NCT01249742

Brief Summary

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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P25-P50 for not_applicable diabetes-mellitus

Timeline
Completed

Started Feb 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

November 22, 2010

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 30, 2010

Completed
Last Updated

November 30, 2010

Status Verified

November 1, 2010

Enrollment Period

1.2 years

First QC Date

November 22, 2010

Last Update Submit

November 26, 2010

Conditions

Keywords

diabetes mellitusadolescentonline interventionpsychosocialquality of life

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Health Related Quality of Life

    T0: baseline (1 month prior to acces to intervention); T1: (6 months following T0); T2: (12 months following T0).

  • Adolescents' disease knowledge

    T0: baseline (1 month prior to acces to intervention); T1: (6 months following T0); T2: (12 months following T0).

  • Confidence In Diabetes Selfcare

    T0: baseline (1 month prior to acces to intervention); T1: (6 months following T0); T2: (12 months following T0).

  • Glycemic control (HbA1c)

    T0: baseline (1 month prior to acces to intervention); T1: (6 months following T0); T2: (12 months following T0).

  • Degree of use of intervention

    T1 (6 months following start of intervention)

Interventions

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 Criteria

Age12 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • adolescents who were unable to read questionnaires because of language, or cognitive problems were excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Diabetes Center Nijmegen

Nijmegen, Gelderland, Postbus 9015; 6500 GS, Netherlands

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 22, 2010

First Posted

November 30, 2010

Study Start

February 1, 2009

Primary Completion

April 1, 2010

Study Completion

November 1, 2010

Last Updated

November 30, 2010

Record last verified: 2010-11

Locations