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

November 26, 2010 updated by: Radboud University Medical Center

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?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
    • Gelderland
      • Nijmegen, Gelderland, Netherlands, Postbus 9015; 6500 GS
        • Children's Diabetes Center Nijmegen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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
Time Frame: T0: baseline (1 month prior to acces to intervention); T1: (6 months following T0); T2: (12 months following T0).
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
Time Frame: T0: baseline (1 month prior to acces to intervention); T1: (6 months following T0); T2: (12 months following T0).
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
Time Frame: T0: baseline (1 month prior to acces to intervention); T1: (6 months following T0); T2: (12 months following T0).
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)
Time Frame: T0: baseline (1 month prior to acces to intervention); T1: (6 months following T0); T2: (12 months following T0).
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
Time Frame: T1 (6 months following start 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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radboud University Medical Center

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

April 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

November 22, 2010

First Submitted That Met QC Criteria

November 26, 2010

First Posted (Estimate)

November 30, 2010

Study Record Updates

Last Update Posted (Estimate)

November 30, 2010

Last Update Submitted That Met QC Criteria

November 26, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007.13.003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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