Condition category
Nutritional, Metabolic, Endocrine
Date applied
20/12/2005
Date assigned
20/12/2005
Last edited
31/07/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr M. de Wit

ORCID ID

Contact details

VU University Medical Centre
Medical Psychology
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
+31 (0)20 444 8420
m.dewit@vumc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Diabetes Research Fund: 2003.00.020; NTR149

Study information

Scientific title

Acronym

DiaQuest

Study hypothesis

Three successive health-related quality of life (HRQoL) assessments, performed preceding the outpatient consultation with the paediatrician, impact positively on psychosocial adaptation, satisfaction with care, and glycaemic control at 12 months follow-up.

Ethics approval

Ethics approval received from the local medical ethics committee

Study design

Multicentre, randomised, active controlled crossover trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Diabetes Mellitus Type I (DM type I)

Intervention

In a prospective multi-centre study, the effects are studied of an office-based, computerised Health-Related Quality of Life assessment in adolescent type 1 diabetes patients, prior to their periodic outpatient consultation. The outcomes of the assessment are discussed during consultation, as a means of tailoring care to the (changing) psychosocial needs of the adolescent with diabetes.

The study is carried out in four paediatric diabetes outpatient clinics (n=120), including the VUMC. At baseline, a comprehensive medico-psychosocial assessment is scheduled in participating patients and their parent(s). After randomisation, two centres in the control condition continue to deliver care-as-usual (3-monthly outpatient consultations). In the two centres randomised to the experimental condition, three successive HRQOL assessments are carried out prior to the 3-monthly consultation and outcomes are discussed during consultation.

After 12 months, centres cross over to the other study arm, and patients are followed up for another 12 months. The study thus has a duration of 24 months per patient.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Psychosocial adaptation
2. Satisfaction with care
3. Glycaemic control

Secondary outcome measures

1. Duration of the consultation
2. The topics discussed
3. Diabetes care-related actions
4. Patient-and parent related characteristics

Overall trial start date

01/09/2004

Overall trial end date

01/09/2008

Reason abandoned

Eligibility

Participant inclusion criteria

Adolescents in the age range 13 - 18 with type 1 diabetes.

Participant type

Patient

Age group

Child

Gender

Not Specified

Target number of participants

120

Participant exclusion criteria

1. Unable to read and speak Dutch
2. Mental retardation
3. Treatment for an organic psychiatric disorder

Recruitment start date

01/09/2004

Recruitment end date

01/09/2008

Locations

Countries of recruitment

Netherlands

Trial participating centre

VU University Medical Centre
Amsterdam
1081 BT
Netherlands

Sponsor information

Organisation

Vrije University Medical Centre (VUMC) (The Netherlands)

Sponsor details

EMGO-Institute and Department of Public and Occupational Health
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands

Sponsor type

University/education

Website

http://www.vumc.nl

Funders

Funder type

Charity

Funder name

Diabetes Research Fund (The Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in http://www.ncbi.nlm.nih.gov/pubmed/18509204

Publication citations

  1. Results

    de Wit M, Delemarre-van de Waal HA, Bokma JA, Haasnoot K, Houdijk MC, Gemke RJ, Snoek FJ, Monitoring and discussing health-related quality of life in adolescents with type 1 diabetes improve psychosocial well-being: a randomized controlled trial., Diabetes Care, 2008, 31, 8, 1521-1526, doi: 10.2337/dc08-0394.

Additional files

Editorial Notes