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

This study has been completed.
Sponsor:
Collaborator:
Dutch Diabetes Research Foundation
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT01249742
First received: November 22, 2010
Last updated: November 26, 2010
Last verified: November 2010

November 22, 2010
November 26, 2010
February 2009
April 2010   (final data collection date for primary outcome measure)
Patients' Evaluation of Quality of Care [ Time Frame: T0: baseline (1 month prior to acces to intervention); T1: (6 months following T0); T2: (12 months following T0). ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01249742 on ClinicalTrials.gov Archive Site
  • Health Related Quality of Life [ Time Frame: T0: baseline (1 month prior to acces to intervention); T1: (6 months following T0); T2: (12 months following T0). ] [ Designated as safety issue: No ]
    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).
  • Adolescents' disease knowledge [ Time Frame: T0: baseline (1 month prior to acces to intervention); T1: (6 months following T0); T2: (12 months following T0). ] [ Designated as safety issue: No ]
    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 .
  • Confidence In Diabetes Selfcare [ Time Frame: T0: baseline (1 month prior to acces to intervention); T1: (6 months following T0); T2: (12 months following T0). ] [ Designated as safety issue: No ]
    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".
  • Glycemic control (HbA1c) [ Time Frame: T0: baseline (1 month prior to acces to intervention); T1: (6 months following T0); T2: (12 months following T0). ] [ Designated as safety issue: No ]
    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.
  • Degree of use of intervention [ Time Frame: T1 (6 months following start of intervention) ] [ Designated as safety issue: No ]
    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.
Same as current
Not Provided
Not Provided
 
Sugarsquare. Focus on the Adolescent: Digital Treatment of Type 1 Diabetes Through the Internet
Sugarsquare. Focus on the Adolescent: Digital Treatment of Type 1 Diabetes Through the Internet

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?

Not Provided
Interventional
Not Provided
Allocation: Randomized
Masking: Open Label
Primary Purpose: Supportive Care
Diabetes Mellitus
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.
Not Provided
Boogerd EA, Noordam C, Kremer JA, Prins JB, Verhaak CM. Teaming up: feasibility of an online treatment environment for adolescents with type 1 diabetes. Pediatr Diabetes. 2014 Aug;15(5):394-402. doi: 10.1111/pedi.12103. Epub 2013 Dec 18.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
65
November 2010
April 2010   (final data collection date for primary outcome measure)

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
Both
12 Years to 21 Years
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01249742
2007.13.003
No
Dr. C. Verhaak, Radboud University Nijmegen, Medical Center
Radboud University
Dutch Diabetes Research Foundation
Principal Investigator: Emiel Boogerd, MSc. Radboud University Nijmegen, Medical Center
Principal Investigator: Chris Verhaak, Dr. Radboud University Nijmegen, Medical Center
Principal Investigator: Kees Noordam, Dr. Radboud University Nijmegen, Medical Center
Radboud University
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP