Sugarsquare. Focus on the Adolescent: Digital Treatment of Type 1 Diabetes Through the Internet

Study Overview
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Brief Summary
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Background The treatment of diabetes is multidisciplinary. Alignment of care of the various professional disciplines is, however, not always optimal. This can lead to confusion about treatment interventions and behavioral advices. In adolescence, good fine-tuned care is of extreme importance because of the difficulties in regulation of the disease in this phase of life (Snoek, 2004). These difficulties are due to biological changes but also to socio-psychological developmental changes. The adolescents' psychological development demands more autonomy and responsibility for the diabetes (care) by the adolescent. The social development can conflict with the treatment regime, because of the adolescents' social needs (ADA, 2001; Houdijk, 1998; Snoek, 2004). In this study the investigators assess whether an interactive website, on which adolescents with diabetes and their treatment team can communicate, leads to better alignment of care and better control over the disease. Intervention The diabetes has great impact on the adolescents' everyday life. Finding a balance between more autonomy, participating in social life with (healthy) peers and control of the disease is difficult and seems to act as a thread during this phase in life. This can lead to questions and uncertainty at any given moment. The interactive website provides the adolescent access to information and to his or her individual treatment plan and advices fitted to his or her condition and life. The adolescent can pose questions at any given moment through the online forum and their personal treatment page. Since the treatment team answers the question within a day, fit between diabetes care and adolescents' everyday life is optimized. Research question Does an online interactive treatment environment, on which adolescents with diabetes can communicate with their treatment team, lead to better fit of care and to better disease control?

Official Title
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Sugarsquare. Focus on the Adolescent: Digital Treatment of Type 1 Diabetes Through the Internet

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Behavioral: Internet intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adolescents aged 12 and older; diagnosed with diabetes mellitus; receiving regular outpatient hospital-delivered diabetes care provided by the Children's Diabetes Center Nijmegen (CDCN) Exclusion Criteria: adolescents who were unable to read questionnaires because of language, or cognitive problems were excluded

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Internet intervention|Our intervention, Sugarsquare, is a secured treatment environment only accessible by patients of the KDCN and members of the treatment team. Sugarsquare consists of two main sections. The first section is a semi-public setting on which adolescents can exchange experiences with their diabetes (care) through a forum and a real time chat-application. All patients and treatment team members can see all messages posted here. The second section consists of patients' individual pages with treatment overview and an application for private interaction with the treatment team. Patients can only access their own individual page; treatment team members can access pages of all patients. Sugarsquare is a secured webpage, accessible only through computers equipped with the right certificate (access device) and by using the appointed username-password combination.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients' Evaluation of Quality of Care | Participants' appreciation of our diabetes care was assessed using the Patients' Evaluation of Quality of Diabetes care (PEQ-D; Pouwer & Snoek, 2002). This questionnaire consists of 14 items, such as: 'The amount of information I receive from the doctor is…'. The adolescent is asked to answer by means of a 5-point lykert scale varying from 1) bad to 5) excellent. | T0: baseline (1 month prior to acces to intervention); T1: (6 months following T0); T2: (12 months following T0). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health Related Quality of Life | Health-related quality of life was measured by means of the PedsQl 3.0 diabetes module (Varni, 2004). The Dutch translation was used, which shows good psychometric properties for clinical application in pediatric diabetes care (de Wit, 2008). The questionnaire consists of 28 items and can be subdivided into five subscales; diabetes symptoms, treatment barriers, treatment adherence, worry, and communication. Example of item: 'I feel hungry' (subscale diabetes symptoms). Al items can be answered using a 5-point lykert scale, varying from 0 (never) to 4 (almost always). | T0: baseline (1 month prior to acces to intervention); T1: (6 months following T0); T2: (12 months following T0). | 
| Adolescents' disease knowledge | Diabetes knowledge was measured using the Diabetes Knowledge Questionnaire (Fitzgerald, 1998). This questionnaire has shown to have good psychometric properties (Fitzgerald, 1998). The questionnaire was translated in Dutch especially for this study. The final Dutch version, DKT-NL, consisted of 21 multiple choice questions, such as 'sings of ketoacidosis include… '. Possible answers were: a) shakiness, b) sweating, c) vomiting (right answer), d) low blood glucose . | T0: baseline (1 month prior to acces to intervention); T1: (6 months following T0); T2: (12 months following T0). | 
| Confidence In Diabetes Selfcare | Participants' self-efficacy was determined through use of the Confidence In Diabetes Selfcare questionnaire (CIDS; van de ven, 2004). The questionnaire contains 20 items, all referring to the perceived ability to perform diabetes self-care tasks. All items are preceded by I believe I can… , and can be answered on a 5-point lykert scale, varying from 1) No, I am sure I cannot to 5) Yes, I am sure I can). An example is I believe I can… adjust my insulin when I am sick. | T0: baseline (1 month prior to acces to intervention); T1: (6 months following T0); T2: (12 months following T0). | 
| Glycemic control (HbA1c) | Patients' Glycemic control was derived from their files. 'Old' HbA1c values were converted to new HbA1c values using the calculator of the Dutch Diabetes Federation (NDF, 2010). New HbA1c values were used in the analyses. | T0: baseline (1 month prior to acces to intervention); T1: (6 months following T0); T2: (12 months following T0). | 
| Degree of use of intervention | The degree of use of our intervention was measured by frequency of use of adolescents of different applications. We therefore logged all action of adolescents on Sugarsquare. Examples of variables are number of page views, number of posted messages on the forum, number of attended chat sessions and number of started discussions with professional caregivers. Table 3 gives insight in all actions included in the analysis. | T1 (6 months following start of intervention) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes mellitus, adolescent, online intervention, psychosocial, quality of life