Clinical trial NCT01249742: Sugarsquare. Focus on the Adolescent: Digital Treatment of Type 1 Diabetes Through the Internet
Official title: Sugarsquare. Focus on the Adolescent: Digital Treatment of Type 1 Diabetes Through the Internet
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: diabetes mellitus
adolescent
online intervention
psychosocial
quality of life
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Dutch Diabetes Research Foundation
First posted: 2010-11-30
Enrollment: 65
Sex: ALL
Minimum age (years): 12
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: SUPPORTIVE_CARE

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?


Eligibility 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

Primary outcomes:
measure: Patients' Evaluation of Quality of Care
timeFrame: T0: baseline (1 month prior to acces to intervention); T1: (6 months following T0); T2: (12 months following T0).
Secondary outcomes:
measure: Health Related Quality of Life
timeFrame: T0: baseline (1 month prior to acces to intervention); T1: (6 months following T0); T2: (12 months following T0).
measure: Adolescents' disease knowledge
timeFrame: T0: baseline (1 month prior to acces to intervention); T1: (6 months following T0); T2: (12 months following T0).
measure: Confidence In Diabetes Selfcare
timeFrame: T0: baseline (1 month prior to acces to intervention); T1: (6 months following T0); T2: (12 months following T0).
measure: Glycemic control (HbA1c)
timeFrame: T0: baseline (1 month prior to acces to intervention); T1: (6 months following T0); T2: (12 months following T0).
measure: Degree of use of intervention
timeFrame: T1 (6 months following start of intervention)
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Children's Diabetes Center Nijmegen
state: Gelderland
Study officials:
affiliation: Radboud University Nijmegen, Medical Center
name: Emiel Boogerd, MSc.
role: PRINCIPAL_INVESTIGATOR
affiliation: Radboud University Nijmegen, Medical Center
name: Chris Verhaak, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Radboud University Nijmegen, Medical Center
name: Kees Noordam, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.