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
  Purpose

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?


Condition Intervention
Diabetes Mellitus
Behavioral: Internet intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Sugarsquare. Focus on the Adolescent: Digital Treatment of Type 1 Diabetes Through the Internet

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 65
Study Start Date: February 2009
Study Completion Date: November 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
  Eligibility

Ages Eligible for Study:   12 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01249742

Locations
Netherlands
Children's Diabetes Center Nijmegen
Nijmegen, Gelderland, Netherlands, Postbus 9015; 6500 GS
Sponsors and Collaborators
Radboud University
Dutch Diabetes Research Foundation
Investigators
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
  More Information

No publications provided

Responsible Party: Dr. C. Verhaak, Radboud University Nijmegen, Medical Center
ClinicalTrials.gov Identifier: NCT01249742     History of Changes
Other Study ID Numbers: 2007.13.003
Study First Received: November 22, 2010
Last Updated: November 26, 2010
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Radboud University:
diabetes mellitus
adolescent
online intervention
psychosocial
quality of life

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on July 22, 2014