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Web-based guided insulin self-titration in patients with type 2 diabetes: the Di@log study. Design of a cluster randomised controlled trial [TC1316]

Web-based guided insulin self-titration in patients with type 2 diabetes: the Di@log study.... Background: Many patients with type 2 diabetes (T2DM) are not able to reach the glycaemic target level of HbA1c < 7.0%, and therefore are at increased risk of developing severe complications. Transition to insulin therapy is one of the obstacles in diabetes management, because of barriers of both patient and health care providers. Patient empowerment, a patient-centred approach, is vital for improving diabetes management. We developed a web-based self-management programme for insulin titration in T2DM patients. The aim of our study is to investigate if this internet programme helps to improve glycaemic control more effectively than usual care. Methods/Design: T2DM patients (n = 248), aged 35–75 years, with an HbA1c ≥ 7.0%, eligible for treatment with insulin and able to use the internet will be selected from general practices in two different regions in the Netherlands. Cluster randomisation will be performed at the level of general practices. Patients in the intervention group will use a self-developed internet programme to assist them in self- titrating insulin. The control group will receive usual care. Primary outcome is the difference in change in HbA1c between intervention and control group. Secondary outcome measures are quality of life, treatment satisfaction, diabetes self-efficacy and frequency of hypoglycaemic episodes. Results will be analysed according to the intention-to-treat principle. Discussion: An internet intervention supporting self-titration of insulin therapy in T2DM patients is an innovative patient-centred intervention. The programme provides guided self-monitoring and evaluation of health and self-care behaviours through tailored feedback on input of glucose values. This is expected to result in a better performance of self-titration of insulin and consequently in the improvement of glycaemic control. The patient will be enabled to 'discover and use his or her own ability to gain mastery over his/her diabetes' and therefore patient empowerment will increase. Based on the self-regulation theory of Leventhal, we hypothesize that additional benefits will be achieved in terms of increases in treatment satisfaction, quality of life and self-efficacy. Trial registration: Dutch Trial Register TC1316. Page 1 of 9 (page number not for citation purposes) BMC Family Practice 2009, 10:40 http://www.biomedcentral.com/1471-2296/10/40 IBCTs with different characteristics, for a wide range of Background The prevalence and incidence of type 2 diabetes mellitus chronic diseases. (T2DM) is high and the number of persons with T2DM is growing rapidly to be 366 million in 2030 [1]. Interna- The use of IBCT in diabetes care has been mainly focussed tional guidelines recommend tight glycaemic control, in on the improvement of glycaemic control. Several studies order to prevent the onset or to reduce the progression of found promising results making use of different aspects of complications associated with T2DM [2-5]. However, the opportunities of IBCT: improving communication achieving tight glycaemic targets represents a major chal- and computerized educational programs [13,14], or mak- lenge. A Dutch study found that at least 30 percent of ing use of a web-based glucose monitoring system [15- T2DM patients under care of General Practitioners (GPs) 19]. A meta-analysis of 16 studies in which home glucose do not achieve good glycaemic control [6]. records were used to perform computer-assisted insulin dose adjustment by clinicians showed a significant Insulin therapy should be started when other therapies improvement of HbA1c [20]. To our knowledge, compu- fail to reach the glycaemic target of HbA1c < 7.0% [5]. ter-assisted insulin self-titration has not yet been studied Nonetheless, both patients and health care providers in (previous insulin-naive) T2DM patients. In addition, often appear reluctant to start insulin therapy [7-9]. GPs the causal pathways between supposed improved out- largely do not feel familiar with the perceived complexity comes and IBCT applications in diabetes care remained of the insulin treatment regimen or they think it is too unclear, because of lack of clarity in how technological time consuming [7,8]. Patients as well as health profes- innovations of IBCTs were defined and how their impact sionals fear negative side effects like weight gain and was measured [21]. In this study we will investigate the hypoglycaemia feeding into "psychological insulin resist- use of an IBCT application in T2DM patients based on a ance", causing unwanted delay of insulin initiation [9]. theoretical framework for a better understanding and Therefore, it is important to develop tools that facilitate interpretation of the outcomes. the transition to insulin therapy with subsequent positive effects on glycaemic control. Interactive Behaviour Theoretical background Change Technology (IBCT), including the use of hardware The self-titration of insulin supported by an internet pro- gramme is based on the patient empowerment approach, and software to promote and sustain behaviour changes, could provide such a tool [10], and make the titration of defined as 'helping people to discover and use their own insulin become easier for both the patient and the health ability to gain mastery over their diabetes' [22]. The key care provider. Moreover, a patient-driven insulin titration element of patient empowerment in diabetes is to facili- has already proven to be successful [11]. With IBCT in the tate self-management [22,23]. Diabetes outcomes are form of an internet programme, self-titration (i.e. self- largely dependent on the daily self-care activities of the monitoring of blood glucose and self-adjustment of insu- patient [24-26]. Empowering patients to better under- lin dose) could be further facilitated. stand and self-manage their diabetes therefore is key, to achieve satisfactory diabetes outcomes, quality of life, sat- Web-based diabetes management isfaction with treatment and better communication with IBCT is one potential resource for improving diabetes caregivers [27-29]. The benefits for the caregivers are an management. In general it assists patients and their clini- increased satisfaction in work, and achievement of treat- cians in monitoring changes in health and self-care needs. ment goals [29]. Secondly, it supports patients' efforts to make behaviour changes by promoting health and effective self-care, and Building on the patient empowerment approach, we thirdly it enhances communication between patients and developed the content and process of our study guided by potential supports for their disease management. IBCT the principles of the self-regulation theory. This theory increases patients' access to the types of services available was elaborated by Leventhal and colleagues and it pro- from their health care team [10]. poses that individuals will use strategies that are based on the understanding of their illness and new experiences Several reviews about utilization of IBCT applications to [30,31]. The theory delineates five core dimensions of ill- improve care of chronic illness have been published, and ness representations (peoples' perceptions of and beliefs these generally have been positive [10]. A systematic about an illness): identity, cause, timeline, consequences review assessing the effects of IBCT for people with a and controllability of the disease in terms of prevention chronic disease found that IBCTs appeared to improve and cure. Through experience and feedback mechanisms, users' knowledge, social support, health behaviours, self- perceptions can be influenced [32]. Web-based support efficacy (a person's belief in their capacity to perform spe- programmes can provide instant and constructive feed- cific skills in a specific situation) and clinical outcomes back. Illness perceptions could change and confidence [12]. However, the included studies involved different and autonomy could increase. Higher self-efficacy beliefs Page 2 of 9 (page number not for citation purposes) BMC Family Practice 2009, 10:40 http://www.biomedcentral.com/1471-2296/10/40 and higher control perceptions are associated with better Setting metabolic control [33]. Participants will be recruited from general practitioners in the region of Amsterdam and Twente in The Netherlands. In our study we will investigate a patient-centred internet A pilot study among diabetes nurses (n = 2) and diabetes intervention supporting self-titration of insulin therapy in patients using insulin (n = 4) from the Diabetes Research T2DM patients. The internet programme will promote Center VUmc in Hoorn has preceded the intervention to self-regulatory behaviour by effective self-monitoring and test the user friendliness and content of the internet pro- evaluation of self-care behaviours through feedback on gramme. The user friendliness was experienced as good by input of the patients' glucose values. This is expected to means that both the nurses and patients were satisfied result in improved self-management skills, self-efficacy about the content of the program and were able to use all and subsequent glycaemic control. Successful self-regula- aspects of the programme easily. They also had the opin- tion of diabetes is expected to translate into better quality ion that the program could be used by people not very of life and treatment satisfaction compared to the control familiar with using the internet. Only some textual group, where there is less emphasis on patients' self-man- changes in the software were made. The present manu- agement. script can be regarded as the definitive study protocol. Objectives Study population The primary objective of the study is to determine the The target population consists of T2DM patients (35–75 effect on glycaemic control (HbA1c) of a patient-centred years) from general practitioners with suboptimal con- web-based insulin-titration programme in suboptimal trolled glucose (i.e. HbA1c ≥ 7.0%) and maximal oral controlled T2DM patients starting insulin treatment. hypoglycaemic agents, not using insulin. Inclusion and exclusion criteria are listed in Table 1. Secondary objectives are to assess the effects of the inter- vention on frequency of hypoglycaemic episodes, illness Randomisation and treatment allocation perceptions, self-efficacy, treatment satisfaction, and qual- General practices will be randomly assigned to the inter- ity of life. vention or control group using a computerized randomi- sation programme. In case a practice nurse takes care of the insulin titration (working for one or more general Methods/Design Design of the study practices), the practice nurse will be randomised and cor- The design of the study will be a cluster randomised con- responding general practice(s) will be allocated to one of trolled trial at the level of general practices in order to the groups. It is desirable that the two groups will be sim- eliminate the influence of contamination of treating ilar with regard to the amount of patients in each group. patients from both the intervention and control group at For that reason we will apply stratified randomisation the same time. The GP or practice nurse can become more [34]. Clusters with one or two general practices and clus- conscious of the treatment process and therefore be stim- ters with three or more general practices will be ran- ulated to improve their usual care for the control group as domised separately. Randomisation will be performed by well. The Medical Ethics Committee of the VU University the manager of the website company (Curavista B.V., Medical Center in Amsterdam approved the study design, Geertruidenberg, the Netherlands), who is independent protocols, information letters and informed consent of the patients and their care. Patients in the intervention form. group will self-adjust the insulin dose supported by an Table 1: Inclusion and exclusion criteria Inclusion criteria • Type 2 diabetes mellitus patients from selected general practices • Between 35 and 75 years • HbA1c ≥ 7.0% in combination with maximal oral hypoglycaemic agents (i.e. the combination of two oral medicines, what cannot further be increased) • Used to a computer and used to the internet • Ability and willingness to inject insulin • Ability and willingness to perform self monitoring of blood glucose • Written informed consent • Understanding of Dutch language Exclusion criteria • Serious cognitive impairment • Serious other endocrine disorders • Serious disease with a life expectancy < 1 year • Corticosteroid use Page 3 of 9 (page number not for citation purposes) BMC Family Practice 2009, 10:40 http://www.biomedcentral.com/1471-2296/10/40 internet programme and receive education before starting practices using a standard protocol provided by the inves- insulin. The control group will receive physician-driven tigators. The patients will receive a manual how to use the (GP or practice nurse) adjustments, i.e. the GP or practice internet programme. nurse will perform the insulin titration in his/her own manner, guided by guidelines from the Dutch College of The internet programme is accessible through a log-in General Practitioners. procedure, requiring a log-in name and a password. The programme is not accessible for the control group or oth- When a patient is eligible to participate in our study the ers without permission. In case of problems, patients can GP or practice nurse will provide a letter of invitation and always contact their practice nurse or GP, who do have an information brochure of the trial based on the assigned access to the online data of their patients. group. The next visit will be scheduled one week later in which the patient can give his or her informed consent to Patients will start with 10 IE insulin glargine. The next participate in the trial. day, a patient has to log-in in order to start the internet programme, that consists of an online-diary with compu- The flow of the patients is registered by the investigator terized algorithms. Feedback will be given on fasting (MR), according to a flow diagram recommended by the blood glucose (FBG) measurements that have to be com- CONSORT statement and its extended version to cluster pleted in the diary. The programme will reply with an randomised trials [35,36]. Reasons for withdrawal are reg- insulin dose advice when two FBG measurements (on two istered by the practice nurse or GP. Figure 1 shows the successive days) are inputted (+ 4 IE when FBG exceeds 10 design of the study. mmol/l for 2 consecutive days; + 2 IE when FBG is between 7–10 mmol/l for 2 consecutive days; – 2 IE when Blinding FBG is between 2.5–4 mmol/l for 2 consecutive days; – 4 It is impossible to blind the participants and health care IE when FBG is below 2.5 mmol/l for 2 consecutive days). providers (GP and practice nurse) for the intervention. In case of a high or low FBG level, the programme will The investigators will remain blinded during the entire also respond with a feedback question, guided by the self- intervention. regulation theory. According to the patients' answer, advice will be given on the concerning item (e.g. adjust- Study procedure ment of diet or increase of physical activity). Feedback will Approximately 62 GPs (see 'sample size calculation') will also be given visually in colours, tables and graphics. be recruited by the principle investigator (MR) and there- after randomly assigned to the intervention group or con- The process of using the online-diary will continue until trol group. Their patients will be allocated to the assigned the patient has reached a normal FBG (FBG between 4.0 group. and 7.0 mmol/L). At that point he/she is advised to make a 5-point day-curve. Dependent on the value of one of the In the present study, eligible patients will receive insulin measured glucose values, the internet programme will glargine. Once-daily injection of a long-acting insulin is automatically respond with a feedback question or will attractive, because of the simple dose adjustments based give advice to repeat the day-curve after 2 days. When a on fasting blood glucose values. It provides at least equiv- stable insulin dose is reached (all measurements are alent glycaemic control to NPH insulin but with a lower within the range of 4.0 – 9.0 mmol/L), it is advised to incidence of hypoglycaemia [5,25,37]. The GP is free to measure FBG once a week. When repeated day-curves (4 continue all oral agents, except for thiazolidediones [4]. day-curves in approximately one week) are not within normal range, it is advised to contact the GP or practice Intervention group nurse. Protocols for how to act in different situations will When informed consent is given, patients in the interven- be provided to the GP's. If another or additional (short- tion group will receive individual education on diabetes acting) insulin is started, patients will not be able to use in general, all aspects of insulin treatment, the use of a the internet programme any longer. This is also the case if self-monitoring device, the importance of self-monitor- the insulin dose exceeds 80 IE. If the GP or practice nurse ing, and aspects of hypo- and hyperglycaemia. In addi- needs extra advice, a diabetes nurse from the Diabetes tion, information about diabetes in general and its Research Center can be contacted. management is available on the trial website (provided by Control group http://www.diep.info[38]), an online education pro- gramme developed by the University of Maastricht and Patients in the control group will receive individual the Academic Hospital Maastricht, the Netherlands). The instructions with regard to insulin dose-adjustments from education will be given in two sessions (with an interval their GP or practice nurse as usual. The number or type of of 1 or 2 weeks) by the GP or practice nurse in general contacts might differ per practice. The titration scheme of Page 4 of 9 (page number not for citation purposes) BMC Family Practice 2009, 10:40 http://www.biomedcentral.com/1471-2296/10/40 F Figure 1 lowchart of the study Flowchart of the study. The online diary is used for monitoring blood glucose measurements. Feedback consistsof 1. a graphic presentation of the input 2. a dose advice for thenext 2 days or coming period 3. compli- ments/advice. Alerts are generated when there is a medical urgency: hypoglycaemia (< 2.5 mmol/l) or hyperglycaemia (FBG > 20 mmol/l). When the patient gets an alert (feedback and advice), this is also sent to the GP. Follow up consists of questionnaires and measurements of physical and clinical characteristics (see text: 'outcome assess- ment'). Page 5 of 9 (page number not for citation purposes) BMC Family Practice 2009, 10:40 http://www.biomedcentral.com/1471-2296/10/40 insulin glargine will be determined by the GP or practice forming self-care activities on 5-point Likert scale [45]. It nurse. Because there is no strict regimen, this can also dif- will be measured at baseline, 3, 6 and 12 months and will fer per practice. The patients are offered access to the infor- be used in evaluating the theoretical background. mation provided on the trial website and for completing the web-based questionnaires only. GPs or practice nurses � Illness perceptions are assessed with the brief Illness Per- can contact a diabetes nurse from the Diabetes Research ception Questionnaire (brief-IPQ). This is a 9-item ques- Center concerning questions about the insulin therapy. tionnaire assessing the five core dimensions of illness representations (illness identity, timeline, personal con- Outcome assessment trol, treatment control, cause) according to Leventhal's Outcome measurements are assessed by means of self- theory of self-regulation [46]. It will be measured at base- administered web-based questionnaires (accessible with a line, 3, 6 and 12 months to determine changes in patients' log-in name and password provided by email for both the representations regarding diabetes and its controllability intervention and the control group) and physical exami- and will also be used in evaluating the theoretical back- nation at the general practices. If questionnaires are not ground. completed within one week an email-reminder will be sent to the participants. In case of no response, a phone � The patient-reported number of hypoglycaemias will be call to their general practice will be made by the investiga- measured by means of a hypoglycaemia diary in which tor. Physical and clinical data will be obtained from the the patient report the severity of each event, glucose value, usual 3-monthly check-ups for diabetes patients in their self-treatment and need of assistance. own practice. The practice nurse or GP will record patients' diabetes duration, co-morbidity, pre-existing Other data collection diabetes complications, and medication at baseline. � Patient characteristics, internet use (assessed on baseline): demographic variables (age, gender, marital status, Primary outcome measure nationality, socio-economic state); experience in use of The primary outcome measure is the difference in change the internet; smoking (cigarettes/day) and alcohol in glycaemic control (HbA1c) between intervention and (glasses/day) use. control group. HbA1c will be measured at baseline, 3 and 12 months. The measurement of HbA1c at 6 or 9 months � Medication, diabetes care use: Total required insulin dose will take place only if HbA1c is still above 7% at 3 respec- (every 3 months this will be self-reported in the web- tively 6 months. based questionnaire); Time delay to reach stable insulin dose (i.e. HbA1c < 7.0%); (Oral) medication changes Secondary outcome measures (data obtained from pharmacy and GP); Frequency of The following secondary outcomes will be assessed in contacts with health care providers (every 3 months this web-based self-administered questionnaires: will be self-reported in the web-based questionnaire). � Quality of life is assessed with the 12-item Short Form � Physical and clinical measurements (assessed on the usual Health Survey (SF-12) [39], measured at baseline and diabetes check-ups in the general practices every 3 months): after 3 and 12 months. The EuroQol (EQ-5D) [40] will be Weight; Length; Blood pressure; FPG; Lipid spectrum: trig- administered at baseline and after 3, 6 and 12 months. lycerides, total cholesterol, and HDL- and LDL-cholesterol This questionnaire assessing the current health status con- (assessed at baseline and after 12 months). sists of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each with 3 � Depression (assessed on baseline, 3 and 12 months): The levels. Patient Health Questionnaire is used to assess the general health of the patient. This brief PHQ (PHQ-9) consists of � Treatment satisfaction is assessed with the Diabetes 9 items, measured on a four-point scale, in order to assess Treatment Satisfaction Questionnaire status and change depressive disorders during the last two weeks [47]. This version (DTSQs and DTSQc) [41-44]. The 8-item ques- will be assessed because of the possible confounding tionnaires, measure treatment satisfaction and how this effect depression has on self-performing activities. satisfaction has changed on 7-point Likert scale. It will be used as an evaluation instrument of the intervention and � Insulin Perceptions (assessed on baseline, 6 and 12 months): will be measured at baseline, 3 and 12 months. Negative perceptions in insulin naive and insulin-treated patients regarding insulin treatment and changes therein � Self-efficacy beliefs are assessed with the Confidence in are assessed with the Insulin Initiation Perception Scale Diabetes Self Care. This is a 21-item questionnaire, meas- (IIPS), a short version of the Insulin Treatment Appraisal uring the level of confidence a diabetes patient has in per- Scale (ITAS) [48]. Page 6 of 9 (page number not for citation purposes) BMC Family Practice 2009, 10:40 http://www.biomedcentral.com/1471-2296/10/40 Sample size calculation Discussion The sample size is calculated to detect a clinical relevant This article presents a detailed description of a cluster RCT difference of 0.5% in HbA1c between groups. In the Dia- with the aim to investigate the effects of a patient-centred betes Care System West-Friesland the standard deviation internet programme supporting self-titration of insulin (sd) of HbA1c of the general diabetes population is 1.2% therapy in type 2 diabetes patients compared with stand- [49]. A difference (d) between the intervention and con- ard-of-care physician-driven insulin titration. This will trol group in changes of 0.5%, a standard deviation (sd) provide researchers and health care providers the oppor- of 1.2%, an alpha of 0.05 (two-sided), and a power of tunity to critically review the methodological quality, the 80%, the number of patients requested in each group is background theory and the practical issues of the RCT 90. [50]. The key element of this trial is that this web-based self-management intervention in the treatment of T2DM Because cluster randomisation is applied at the level of patients is designed to enhance patient empowerment, general practices, the number of patients has to be multi- what could result in adequate self-management behav- plied with the following formula: 1 + (k-1)ρ, in which ρ is iours (including insulin dose adjustments) that in turn the intercorrelation coefficient (ICC) between practices. will help to improve and sustain glycaemic control. The ICC is statistically determined to be 0.05. k is the number of patients per practice that will join the study. Besides the focus on increasing patient empowerment, a Based on our experience, we estimate that 4 patients per strength is the construction of the intervention guided by practice will make the transition to insulin treatment in the self-regulation theory of Leventhal. The use of a theory one year and meet the criteria of our trial. A participation in general is important for several reasons. A theory helps of 26 general practices is needed per group: to design the intervention, it provides a good base for the evaluation of the intervention ('how does it work (or Number of patients per group *[11 +− (k )ρ]= adjusted number of patients per group not)?') and it will enable other researchers to refine the 90 *[1+− (4 1)0.05]= 104 theory or intervention [51,52]. In designing the internet programme of our study we have used an important Adjusted number of patients per group / k = number of practices s per group aspect of the self-regulation theory: providing feedback 104 / 4 = 26 [32]. This will promote effective self-evaluation of health Furthermore, taking into account a possible dropout rate and self-care behaviours and adjustment of cognitive rep- of 15%, the total number of practices needed is: 2 * 26/ resentations and beliefs and subsequent glycaemic con- (1–0.15) = 62, which means that 248 patients will be trol. We will evaluate our theoretical background by required. investigating if the intervention has increased self-efficacy and changed illness perceptions. Another strength is the Analysis use of internet technology. A large part of the population Descriptive statistics (means ± SD or median and inter in the Netherlands (86% of all households in 2008) has quartile range as appropriate) will be used to describe the access to the internet [53]. Internet can meet different study sample with regard to demographics and baseline needs of patients, like the need of adequate information (clinical) characteristics. On the basis of an intention-to- and continue, access to care [54]. E-health applications treat analysis, differences in changes between the inter- are upcoming and the Dutch Patient Consumer Federa- vention group and control group are calculated with 95% tion (NPCF) has published a vision document, stimulat- confidence intervals at 3, 6 and 12 months for both pri- ing e-health developments [54]. mary and secondary outcomes. The intervention will be provided to patients from two Using t-tests and multiple linear regression – duly adapted different regions in the Netherlands: Amsterdam (an for the multilevel structure of the data – we will compare urban region) and Twente (a rural area), which should changes in HbA1c, number of hypoglyceamias, quality of add to external validity, i.e. generalisability. If our inter- life, treatment satisfaction, illness and insulin perceptions vention proves to be more effective than care as usual, the and confidence in diabetes self-care scores at different internet programme could be widely implemented in gen- time intervals between the groups, with adjustment for eral practices in the Netherlands. important prognostic factors like age, diabetes duration, medication and level of education where appropriate. There are also some limitations in the study design. We Separate analyses of possible effect modifiers (i.e. age, will compare the intervention with usual care. In the depression, previous internet use) will be performed in Netherlands, most general practitioners or their practice order to gain a better understanding as to who benefits nurses take care of insulin titration, but there is no strict most from the intervention. insulin regimen. That means that usual care is not the same in each practice. However, in the sample size calcu- Page 7 of 9 (page number not for citation purposes) BMC Family Practice 2009, 10:40 http://www.biomedcentral.com/1471-2296/10/40 lation we accounted for this by multiplying with an inter- References 1. Wild S, Roglic G, Green A, Sicree R, King H: Global prevalence of correlation coefficient, providing sufficient power to diabetes: estimates for the year 2000 and projections for prevent this bias. Another limitation is the use of different 2030. Diabetes Care 2004, 27:1047-1053. co-medication next to insulin. Except for thiazidediones, 2. A desktop guide to Type 2 diabetes mellitus. 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Long-term effect of the Internet-based glucose monitoring system on HbA1c reduction and glucose stability: a 30- month follow-up study for diabetes management with a Authors' contributions ubiquitous medical care system. Diabetes Care 2006, MR is responsible for the data collection and wrote the 29:2625-2631. 17. Gomez EJ, Hernando ME, Garcia A, Del PF, Cermeno J, Corcoy R, manuscript. GN developed the original idea for the study. Brugues E, De Leiva A: Telemedicine as a tool for intensive The study design was further developed by GN, LW and management of diabetes: the DIABTel experience. Comput MR. All authors have read and approved the final manu- Methods Programs Biomed 2002, 69:163-177. 18. McMahon GT, Gomes HE, Hickson HS, Hu TM, Levine BA, Conlin PR: script. Web-based care management in patients with poorly con- trolled diabetes. Diabetes Care 2005, 28:1624-1629. 19. Yoon KH, Kim HS: A short message service by cellular phone Acknowledgements in type 2 diabetic patients for 12 months. Diabetes Res Clin Pract We would like to thank Esther van Noort and Anton Kool from Curavista 2008, 79:256-261. B.V., Geertruidenberg for developing the website in order to implement 20. Balas EA, Krishna S, Kretschmer RA, Cheek TR, Lobach DF, Boren the study. SA: Computerized knowledge management in diabetes care. Med Care 2004, 42:610-621. 21. Mathur A, Kvedar JC, Watson AJ: Connected health: a new The study is sponsored by Sanofi-Aventis Netherlands B.V., Gouda, the framework for evaluation of communication technology use Netherlands. in care improvement strategies for type 2 diabetes. Curr Dia- betes Rev 2007, 3:229-234. Page 8 of 9 (page number not for citation purposes) BMC Family Practice 2009, 10:40 http://www.biomedcentral.com/1471-2296/10/40 22. Funnell MM: Patient empowerment. Crit Care NursQ 2004, 43. 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Heldoorn M: [Vision document Federation of Patients and Consumer 15:733-750. Organisations in the Netherlands: Health 2.0. Future and importance of e- 34. Pocock SJ: Methods of Randomization. In Clinical trials: A practical health for consumers of care] Utrecht: NPCF; 2008. approach Edited by: Pocock SJ. Chichester: John Wiley & Sons; 1983:66-89. Pre-publication history 35. Elbourne DR, Campbell MK: Extending the CONSORT state- ment to cluster randomized trials: for discussion. Stat Med The pre-publication history for this paper can be accessed 2001, 20:489-496. here: 36. Moher D, Schulz KF, Altman DG: The CONSORT statement: revised recommendations for improving the quality of reports of parallel group randomized trials. BMC Med Res http://www.biomedcentral.com/1471-2296/10/40/pre Methodol 2001, 1:2. pub 37. Barnett A: Dosing of insulin glargine in the treatment of type 2 diabetes. Clin Ther 2007, 29:987-999. 38. [Diabetes Interactive Education Program]. DIEPproject group [http://www.diep.info] 39. Gandek B, Ware JE, Aaronson NK, Apolone G, Bjorner JB, Brazier JE, Bullinger M, Kaasa S, Leplege A, Prieto L, Sullivan M: Cross-valida- Publish with Bio Med Central and every tion of item selection and scoring for the SF-12 Health Sur- scientist can read your work free of charge vey in nine countries: results from the IQOLA Project. International Quality of LifeAssessment. J Clin Epidemiol 1998, "BioMed Central will be the most significant development for 51:1171-1178. disseminating the results of biomedical researc h in our lifetime." 40. EuroQol – a new facility for the measurement of health- Sir Paul Nurse, Cancer Research UK related quality of life. The EuroQol Group. Health Policy 1990, 16:199-208. Your research papers will be: 41. Bradley C: The Diabetes Treatment SatisfactionQuestion- available free of charge to the entire biomedical community naire: DTSQ. In Handbook of Psychology and Diabetes: a guide to psy- chological measurement in diabetes research and practice Edited by: peer reviewed and published immediately upon acceptance Bradley C. Chur, Switzerland: Harwood Academic Publishers; cited in PubMed and archived on PubMed Central 1994:111-132. 42. Bradley C, Lewis KS: Measures of psychological well-being and yours — you keep the copyright treatment satisfaction developed from the responses of peo- BioMedcentral ple with tablet-treated diabetes. Diabet Med 1990, 7:445-451. Submit your manuscript here: http://www.biomedcentral.com/info/publishing_adv.asp Page 9 of 9 (page number not for citation purposes) http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png BMC Family Practice Springer Journals

Web-based guided insulin self-titration in patients with type 2 diabetes: the Di@log study. Design of a cluster randomised controlled trial [TC1316]

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Springer Journals
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Copyright © 2009 by Roek et al; licensee BioMed Central Ltd.
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Medicine & Public Health; General Practice / Family Medicine; Primary Care Medicine
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19508712
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Abstract

Background: Many patients with type 2 diabetes (T2DM) are not able to reach the glycaemic target level of HbA1c < 7.0%, and therefore are at increased risk of developing severe complications. Transition to insulin therapy is one of the obstacles in diabetes management, because of barriers of both patient and health care providers. Patient empowerment, a patient-centred approach, is vital for improving diabetes management. We developed a web-based self-management programme for insulin titration in T2DM patients. The aim of our study is to investigate if this internet programme helps to improve glycaemic control more effectively than usual care. Methods/Design: T2DM patients (n = 248), aged 35–75 years, with an HbA1c ≥ 7.0%, eligible for treatment with insulin and able to use the internet will be selected from general practices in two different regions in the Netherlands. Cluster randomisation will be performed at the level of general practices. Patients in the intervention group will use a self-developed internet programme to assist them in self- titrating insulin. The control group will receive usual care. Primary outcome is the difference in change in HbA1c between intervention and control group. Secondary outcome measures are quality of life, treatment satisfaction, diabetes self-efficacy and frequency of hypoglycaemic episodes. Results will be analysed according to the intention-to-treat principle. Discussion: An internet intervention supporting self-titration of insulin therapy in T2DM patients is an innovative patient-centred intervention. The programme provides guided self-monitoring and evaluation of health and self-care behaviours through tailored feedback on input of glucose values. This is expected to result in a better performance of self-titration of insulin and consequently in the improvement of glycaemic control. The patient will be enabled to 'discover and use his or her own ability to gain mastery over his/her diabetes' and therefore patient empowerment will increase. Based on the self-regulation theory of Leventhal, we hypothesize that additional benefits will be achieved in terms of increases in treatment satisfaction, quality of life and self-efficacy. Trial registration: Dutch Trial Register TC1316. Page 1 of 9 (page number not for citation purposes) BMC Family Practice 2009, 10:40 http://www.biomedcentral.com/1471-2296/10/40 IBCTs with different characteristics, for a wide range of Background The prevalence and incidence of type 2 diabetes mellitus chronic diseases. (T2DM) is high and the number of persons with T2DM is growing rapidly to be 366 million in 2030 [1]. Interna- The use of IBCT in diabetes care has been mainly focussed tional guidelines recommend tight glycaemic control, in on the improvement of glycaemic control. Several studies order to prevent the onset or to reduce the progression of found promising results making use of different aspects of complications associated with T2DM [2-5]. However, the opportunities of IBCT: improving communication achieving tight glycaemic targets represents a major chal- and computerized educational programs [13,14], or mak- lenge. A Dutch study found that at least 30 percent of ing use of a web-based glucose monitoring system [15- T2DM patients under care of General Practitioners (GPs) 19]. A meta-analysis of 16 studies in which home glucose do not achieve good glycaemic control [6]. records were used to perform computer-assisted insulin dose adjustment by clinicians showed a significant Insulin therapy should be started when other therapies improvement of HbA1c [20]. To our knowledge, compu- fail to reach the glycaemic target of HbA1c < 7.0% [5]. ter-assisted insulin self-titration has not yet been studied Nonetheless, both patients and health care providers in (previous insulin-naive) T2DM patients. In addition, often appear reluctant to start insulin therapy [7-9]. GPs the causal pathways between supposed improved out- largely do not feel familiar with the perceived complexity comes and IBCT applications in diabetes care remained of the insulin treatment regimen or they think it is too unclear, because of lack of clarity in how technological time consuming [7,8]. Patients as well as health profes- innovations of IBCTs were defined and how their impact sionals fear negative side effects like weight gain and was measured [21]. In this study we will investigate the hypoglycaemia feeding into "psychological insulin resist- use of an IBCT application in T2DM patients based on a ance", causing unwanted delay of insulin initiation [9]. theoretical framework for a better understanding and Therefore, it is important to develop tools that facilitate interpretation of the outcomes. the transition to insulin therapy with subsequent positive effects on glycaemic control. Interactive Behaviour Theoretical background Change Technology (IBCT), including the use of hardware The self-titration of insulin supported by an internet pro- gramme is based on the patient empowerment approach, and software to promote and sustain behaviour changes, could provide such a tool [10], and make the titration of defined as 'helping people to discover and use their own insulin become easier for both the patient and the health ability to gain mastery over their diabetes' [22]. The key care provider. Moreover, a patient-driven insulin titration element of patient empowerment in diabetes is to facili- has already proven to be successful [11]. With IBCT in the tate self-management [22,23]. Diabetes outcomes are form of an internet programme, self-titration (i.e. self- largely dependent on the daily self-care activities of the monitoring of blood glucose and self-adjustment of insu- patient [24-26]. Empowering patients to better under- lin dose) could be further facilitated. stand and self-manage their diabetes therefore is key, to achieve satisfactory diabetes outcomes, quality of life, sat- Web-based diabetes management isfaction with treatment and better communication with IBCT is one potential resource for improving diabetes caregivers [27-29]. The benefits for the caregivers are an management. In general it assists patients and their clini- increased satisfaction in work, and achievement of treat- cians in monitoring changes in health and self-care needs. ment goals [29]. Secondly, it supports patients' efforts to make behaviour changes by promoting health and effective self-care, and Building on the patient empowerment approach, we thirdly it enhances communication between patients and developed the content and process of our study guided by potential supports for their disease management. IBCT the principles of the self-regulation theory. This theory increases patients' access to the types of services available was elaborated by Leventhal and colleagues and it pro- from their health care team [10]. poses that individuals will use strategies that are based on the understanding of their illness and new experiences Several reviews about utilization of IBCT applications to [30,31]. The theory delineates five core dimensions of ill- improve care of chronic illness have been published, and ness representations (peoples' perceptions of and beliefs these generally have been positive [10]. A systematic about an illness): identity, cause, timeline, consequences review assessing the effects of IBCT for people with a and controllability of the disease in terms of prevention chronic disease found that IBCTs appeared to improve and cure. Through experience and feedback mechanisms, users' knowledge, social support, health behaviours, self- perceptions can be influenced [32]. Web-based support efficacy (a person's belief in their capacity to perform spe- programmes can provide instant and constructive feed- cific skills in a specific situation) and clinical outcomes back. Illness perceptions could change and confidence [12]. However, the included studies involved different and autonomy could increase. Higher self-efficacy beliefs Page 2 of 9 (page number not for citation purposes) BMC Family Practice 2009, 10:40 http://www.biomedcentral.com/1471-2296/10/40 and higher control perceptions are associated with better Setting metabolic control [33]. Participants will be recruited from general practitioners in the region of Amsterdam and Twente in The Netherlands. In our study we will investigate a patient-centred internet A pilot study among diabetes nurses (n = 2) and diabetes intervention supporting self-titration of insulin therapy in patients using insulin (n = 4) from the Diabetes Research T2DM patients. The internet programme will promote Center VUmc in Hoorn has preceded the intervention to self-regulatory behaviour by effective self-monitoring and test the user friendliness and content of the internet pro- evaluation of self-care behaviours through feedback on gramme. The user friendliness was experienced as good by input of the patients' glucose values. This is expected to means that both the nurses and patients were satisfied result in improved self-management skills, self-efficacy about the content of the program and were able to use all and subsequent glycaemic control. Successful self-regula- aspects of the programme easily. They also had the opin- tion of diabetes is expected to translate into better quality ion that the program could be used by people not very of life and treatment satisfaction compared to the control familiar with using the internet. Only some textual group, where there is less emphasis on patients' self-man- changes in the software were made. The present manu- agement. script can be regarded as the definitive study protocol. Objectives Study population The primary objective of the study is to determine the The target population consists of T2DM patients (35–75 effect on glycaemic control (HbA1c) of a patient-centred years) from general practitioners with suboptimal con- web-based insulin-titration programme in suboptimal trolled glucose (i.e. HbA1c ≥ 7.0%) and maximal oral controlled T2DM patients starting insulin treatment. hypoglycaemic agents, not using insulin. Inclusion and exclusion criteria are listed in Table 1. Secondary objectives are to assess the effects of the inter- vention on frequency of hypoglycaemic episodes, illness Randomisation and treatment allocation perceptions, self-efficacy, treatment satisfaction, and qual- General practices will be randomly assigned to the inter- ity of life. vention or control group using a computerized randomi- sation programme. In case a practice nurse takes care of the insulin titration (working for one or more general Methods/Design Design of the study practices), the practice nurse will be randomised and cor- The design of the study will be a cluster randomised con- responding general practice(s) will be allocated to one of trolled trial at the level of general practices in order to the groups. It is desirable that the two groups will be sim- eliminate the influence of contamination of treating ilar with regard to the amount of patients in each group. patients from both the intervention and control group at For that reason we will apply stratified randomisation the same time. The GP or practice nurse can become more [34]. Clusters with one or two general practices and clus- conscious of the treatment process and therefore be stim- ters with three or more general practices will be ran- ulated to improve their usual care for the control group as domised separately. Randomisation will be performed by well. The Medical Ethics Committee of the VU University the manager of the website company (Curavista B.V., Medical Center in Amsterdam approved the study design, Geertruidenberg, the Netherlands), who is independent protocols, information letters and informed consent of the patients and their care. Patients in the intervention form. group will self-adjust the insulin dose supported by an Table 1: Inclusion and exclusion criteria Inclusion criteria • Type 2 diabetes mellitus patients from selected general practices • Between 35 and 75 years • HbA1c ≥ 7.0% in combination with maximal oral hypoglycaemic agents (i.e. the combination of two oral medicines, what cannot further be increased) • Used to a computer and used to the internet • Ability and willingness to inject insulin • Ability and willingness to perform self monitoring of blood glucose • Written informed consent • Understanding of Dutch language Exclusion criteria • Serious cognitive impairment • Serious other endocrine disorders • Serious disease with a life expectancy < 1 year • Corticosteroid use Page 3 of 9 (page number not for citation purposes) BMC Family Practice 2009, 10:40 http://www.biomedcentral.com/1471-2296/10/40 internet programme and receive education before starting practices using a standard protocol provided by the inves- insulin. The control group will receive physician-driven tigators. The patients will receive a manual how to use the (GP or practice nurse) adjustments, i.e. the GP or practice internet programme. nurse will perform the insulin titration in his/her own manner, guided by guidelines from the Dutch College of The internet programme is accessible through a log-in General Practitioners. procedure, requiring a log-in name and a password. The programme is not accessible for the control group or oth- When a patient is eligible to participate in our study the ers without permission. In case of problems, patients can GP or practice nurse will provide a letter of invitation and always contact their practice nurse or GP, who do have an information brochure of the trial based on the assigned access to the online data of their patients. group. The next visit will be scheduled one week later in which the patient can give his or her informed consent to Patients will start with 10 IE insulin glargine. The next participate in the trial. day, a patient has to log-in in order to start the internet programme, that consists of an online-diary with compu- The flow of the patients is registered by the investigator terized algorithms. Feedback will be given on fasting (MR), according to a flow diagram recommended by the blood glucose (FBG) measurements that have to be com- CONSORT statement and its extended version to cluster pleted in the diary. The programme will reply with an randomised trials [35,36]. Reasons for withdrawal are reg- insulin dose advice when two FBG measurements (on two istered by the practice nurse or GP. Figure 1 shows the successive days) are inputted (+ 4 IE when FBG exceeds 10 design of the study. mmol/l for 2 consecutive days; + 2 IE when FBG is between 7–10 mmol/l for 2 consecutive days; – 2 IE when Blinding FBG is between 2.5–4 mmol/l for 2 consecutive days; – 4 It is impossible to blind the participants and health care IE when FBG is below 2.5 mmol/l for 2 consecutive days). providers (GP and practice nurse) for the intervention. In case of a high or low FBG level, the programme will The investigators will remain blinded during the entire also respond with a feedback question, guided by the self- intervention. regulation theory. According to the patients' answer, advice will be given on the concerning item (e.g. adjust- Study procedure ment of diet or increase of physical activity). Feedback will Approximately 62 GPs (see 'sample size calculation') will also be given visually in colours, tables and graphics. be recruited by the principle investigator (MR) and there- after randomly assigned to the intervention group or con- The process of using the online-diary will continue until trol group. Their patients will be allocated to the assigned the patient has reached a normal FBG (FBG between 4.0 group. and 7.0 mmol/L). At that point he/she is advised to make a 5-point day-curve. Dependent on the value of one of the In the present study, eligible patients will receive insulin measured glucose values, the internet programme will glargine. Once-daily injection of a long-acting insulin is automatically respond with a feedback question or will attractive, because of the simple dose adjustments based give advice to repeat the day-curve after 2 days. When a on fasting blood glucose values. It provides at least equiv- stable insulin dose is reached (all measurements are alent glycaemic control to NPH insulin but with a lower within the range of 4.0 – 9.0 mmol/L), it is advised to incidence of hypoglycaemia [5,25,37]. The GP is free to measure FBG once a week. When repeated day-curves (4 continue all oral agents, except for thiazolidediones [4]. day-curves in approximately one week) are not within normal range, it is advised to contact the GP or practice Intervention group nurse. Protocols for how to act in different situations will When informed consent is given, patients in the interven- be provided to the GP's. If another or additional (short- tion group will receive individual education on diabetes acting) insulin is started, patients will not be able to use in general, all aspects of insulin treatment, the use of a the internet programme any longer. This is also the case if self-monitoring device, the importance of self-monitor- the insulin dose exceeds 80 IE. If the GP or practice nurse ing, and aspects of hypo- and hyperglycaemia. In addi- needs extra advice, a diabetes nurse from the Diabetes tion, information about diabetes in general and its Research Center can be contacted. management is available on the trial website (provided by Control group http://www.diep.info[38]), an online education pro- gramme developed by the University of Maastricht and Patients in the control group will receive individual the Academic Hospital Maastricht, the Netherlands). The instructions with regard to insulin dose-adjustments from education will be given in two sessions (with an interval their GP or practice nurse as usual. The number or type of of 1 or 2 weeks) by the GP or practice nurse in general contacts might differ per practice. The titration scheme of Page 4 of 9 (page number not for citation purposes) BMC Family Practice 2009, 10:40 http://www.biomedcentral.com/1471-2296/10/40 F Figure 1 lowchart of the study Flowchart of the study. The online diary is used for monitoring blood glucose measurements. Feedback consistsof 1. a graphic presentation of the input 2. a dose advice for thenext 2 days or coming period 3. compli- ments/advice. Alerts are generated when there is a medical urgency: hypoglycaemia (< 2.5 mmol/l) or hyperglycaemia (FBG > 20 mmol/l). When the patient gets an alert (feedback and advice), this is also sent to the GP. Follow up consists of questionnaires and measurements of physical and clinical characteristics (see text: 'outcome assess- ment'). Page 5 of 9 (page number not for citation purposes) BMC Family Practice 2009, 10:40 http://www.biomedcentral.com/1471-2296/10/40 insulin glargine will be determined by the GP or practice forming self-care activities on 5-point Likert scale [45]. It nurse. Because there is no strict regimen, this can also dif- will be measured at baseline, 3, 6 and 12 months and will fer per practice. The patients are offered access to the infor- be used in evaluating the theoretical background. mation provided on the trial website and for completing the web-based questionnaires only. GPs or practice nurses � Illness perceptions are assessed with the brief Illness Per- can contact a diabetes nurse from the Diabetes Research ception Questionnaire (brief-IPQ). This is a 9-item ques- Center concerning questions about the insulin therapy. tionnaire assessing the five core dimensions of illness representations (illness identity, timeline, personal con- Outcome assessment trol, treatment control, cause) according to Leventhal's Outcome measurements are assessed by means of self- theory of self-regulation [46]. It will be measured at base- administered web-based questionnaires (accessible with a line, 3, 6 and 12 months to determine changes in patients' log-in name and password provided by email for both the representations regarding diabetes and its controllability intervention and the control group) and physical exami- and will also be used in evaluating the theoretical back- nation at the general practices. If questionnaires are not ground. completed within one week an email-reminder will be sent to the participants. In case of no response, a phone � The patient-reported number of hypoglycaemias will be call to their general practice will be made by the investiga- measured by means of a hypoglycaemia diary in which tor. Physical and clinical data will be obtained from the the patient report the severity of each event, glucose value, usual 3-monthly check-ups for diabetes patients in their self-treatment and need of assistance. own practice. The practice nurse or GP will record patients' diabetes duration, co-morbidity, pre-existing Other data collection diabetes complications, and medication at baseline. � Patient characteristics, internet use (assessed on baseline): demographic variables (age, gender, marital status, Primary outcome measure nationality, socio-economic state); experience in use of The primary outcome measure is the difference in change the internet; smoking (cigarettes/day) and alcohol in glycaemic control (HbA1c) between intervention and (glasses/day) use. control group. HbA1c will be measured at baseline, 3 and 12 months. The measurement of HbA1c at 6 or 9 months � Medication, diabetes care use: Total required insulin dose will take place only if HbA1c is still above 7% at 3 respec- (every 3 months this will be self-reported in the web- tively 6 months. based questionnaire); Time delay to reach stable insulin dose (i.e. HbA1c < 7.0%); (Oral) medication changes Secondary outcome measures (data obtained from pharmacy and GP); Frequency of The following secondary outcomes will be assessed in contacts with health care providers (every 3 months this web-based self-administered questionnaires: will be self-reported in the web-based questionnaire). � Quality of life is assessed with the 12-item Short Form � Physical and clinical measurements (assessed on the usual Health Survey (SF-12) [39], measured at baseline and diabetes check-ups in the general practices every 3 months): after 3 and 12 months. The EuroQol (EQ-5D) [40] will be Weight; Length; Blood pressure; FPG; Lipid spectrum: trig- administered at baseline and after 3, 6 and 12 months. lycerides, total cholesterol, and HDL- and LDL-cholesterol This questionnaire assessing the current health status con- (assessed at baseline and after 12 months). sists of 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression), each with 3 � Depression (assessed on baseline, 3 and 12 months): The levels. Patient Health Questionnaire is used to assess the general health of the patient. This brief PHQ (PHQ-9) consists of � Treatment satisfaction is assessed with the Diabetes 9 items, measured on a four-point scale, in order to assess Treatment Satisfaction Questionnaire status and change depressive disorders during the last two weeks [47]. This version (DTSQs and DTSQc) [41-44]. The 8-item ques- will be assessed because of the possible confounding tionnaires, measure treatment satisfaction and how this effect depression has on self-performing activities. satisfaction has changed on 7-point Likert scale. It will be used as an evaluation instrument of the intervention and � Insulin Perceptions (assessed on baseline, 6 and 12 months): will be measured at baseline, 3 and 12 months. Negative perceptions in insulin naive and insulin-treated patients regarding insulin treatment and changes therein � Self-efficacy beliefs are assessed with the Confidence in are assessed with the Insulin Initiation Perception Scale Diabetes Self Care. This is a 21-item questionnaire, meas- (IIPS), a short version of the Insulin Treatment Appraisal uring the level of confidence a diabetes patient has in per- Scale (ITAS) [48]. Page 6 of 9 (page number not for citation purposes) BMC Family Practice 2009, 10:40 http://www.biomedcentral.com/1471-2296/10/40 Sample size calculation Discussion The sample size is calculated to detect a clinical relevant This article presents a detailed description of a cluster RCT difference of 0.5% in HbA1c between groups. In the Dia- with the aim to investigate the effects of a patient-centred betes Care System West-Friesland the standard deviation internet programme supporting self-titration of insulin (sd) of HbA1c of the general diabetes population is 1.2% therapy in type 2 diabetes patients compared with stand- [49]. A difference (d) between the intervention and con- ard-of-care physician-driven insulin titration. This will trol group in changes of 0.5%, a standard deviation (sd) provide researchers and health care providers the oppor- of 1.2%, an alpha of 0.05 (two-sided), and a power of tunity to critically review the methodological quality, the 80%, the number of patients requested in each group is background theory and the practical issues of the RCT 90. [50]. The key element of this trial is that this web-based self-management intervention in the treatment of T2DM Because cluster randomisation is applied at the level of patients is designed to enhance patient empowerment, general practices, the number of patients has to be multi- what could result in adequate self-management behav- plied with the following formula: 1 + (k-1)ρ, in which ρ is iours (including insulin dose adjustments) that in turn the intercorrelation coefficient (ICC) between practices. will help to improve and sustain glycaemic control. The ICC is statistically determined to be 0.05. k is the number of patients per practice that will join the study. Besides the focus on increasing patient empowerment, a Based on our experience, we estimate that 4 patients per strength is the construction of the intervention guided by practice will make the transition to insulin treatment in the self-regulation theory of Leventhal. The use of a theory one year and meet the criteria of our trial. A participation in general is important for several reasons. A theory helps of 26 general practices is needed per group: to design the intervention, it provides a good base for the evaluation of the intervention ('how does it work (or Number of patients per group *[11 +− (k )ρ]= adjusted number of patients per group not)?') and it will enable other researchers to refine the 90 *[1+− (4 1)0.05]= 104 theory or intervention [51,52]. In designing the internet programme of our study we have used an important Adjusted number of patients per group / k = number of practices s per group aspect of the self-regulation theory: providing feedback 104 / 4 = 26 [32]. This will promote effective self-evaluation of health Furthermore, taking into account a possible dropout rate and self-care behaviours and adjustment of cognitive rep- of 15%, the total number of practices needed is: 2 * 26/ resentations and beliefs and subsequent glycaemic con- (1–0.15) = 62, which means that 248 patients will be trol. We will evaluate our theoretical background by required. investigating if the intervention has increased self-efficacy and changed illness perceptions. Another strength is the Analysis use of internet technology. A large part of the population Descriptive statistics (means ± SD or median and inter in the Netherlands (86% of all households in 2008) has quartile range as appropriate) will be used to describe the access to the internet [53]. Internet can meet different study sample with regard to demographics and baseline needs of patients, like the need of adequate information (clinical) characteristics. On the basis of an intention-to- and continue, access to care [54]. E-health applications treat analysis, differences in changes between the inter- are upcoming and the Dutch Patient Consumer Federa- vention group and control group are calculated with 95% tion (NPCF) has published a vision document, stimulat- confidence intervals at 3, 6 and 12 months for both pri- ing e-health developments [54]. mary and secondary outcomes. The intervention will be provided to patients from two Using t-tests and multiple linear regression – duly adapted different regions in the Netherlands: Amsterdam (an for the multilevel structure of the data – we will compare urban region) and Twente (a rural area), which should changes in HbA1c, number of hypoglyceamias, quality of add to external validity, i.e. generalisability. If our inter- life, treatment satisfaction, illness and insulin perceptions vention proves to be more effective than care as usual, the and confidence in diabetes self-care scores at different internet programme could be widely implemented in gen- time intervals between the groups, with adjustment for eral practices in the Netherlands. important prognostic factors like age, diabetes duration, medication and level of education where appropriate. There are also some limitations in the study design. We Separate analyses of possible effect modifiers (i.e. age, will compare the intervention with usual care. In the depression, previous internet use) will be performed in Netherlands, most general practitioners or their practice order to gain a better understanding as to who benefits nurses take care of insulin titration, but there is no strict most from the intervention. insulin regimen. That means that usual care is not the same in each practice. However, in the sample size calcu- Page 7 of 9 (page number not for citation purposes) BMC Family Practice 2009, 10:40 http://www.biomedcentral.com/1471-2296/10/40 lation we accounted for this by multiplying with an inter- References 1. Wild S, Roglic G, Green A, Sicree R, King H: Global prevalence of correlation coefficient, providing sufficient power to diabetes: estimates for the year 2000 and projections for prevent this bias. Another limitation is the use of different 2030. Diabetes Care 2004, 27:1047-1053. co-medication next to insulin. Except for thiazidediones, 2. A desktop guide to Type 2 diabetes mellitus. 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