Monitoring health-related quality of life in adolescents with type 1 diabetes prior to periodic outpatient consultation: impact on psychosocial adaptation, satisfaction with care and glycaemic control - a randomised controlled cross-over study
| ISRCTN | ISRCTN65138334 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN65138334 |
| Protocol serial number | Diabetes Research Fund: 2003.00.020; NTR149 |
| Sponsor | Vrije University Medical Centre (VUMC) (The Netherlands) |
| Funder | Diabetes Research Fund (The Netherlands) |
- Submission date
- 20/12/2005
- Registration date
- 20/12/2005
- Last edited
- 31/07/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr M. de Wit
Scientific
Scientific
VU University Medical Centre
Medical Psychology
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands
| Phone | +31 (0)20 444 8420 |
|---|---|
| m.dewit@vumc.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre, randomised, active controlled crossover trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | DiaQuest |
| Study objectives | 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(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
1. Psychosocial adaptation |
| Key secondary outcome measure(s) |
1. Duration of the consultation |
| Completion date | 01/09/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 13 Years |
| Upper age limit | 18 Years |
| Sex | Not Specified |
| Target sample size at registration | 120 |
| Key inclusion criteria | Adolescents in the age range 13 - 18 with type 1 diabetes. |
| Key exclusion criteria | 1. Unable to read and speak Dutch 2. Mental retardation 3. Treatment for an organic psychiatric disorder |
| Date of first enrolment | 01/09/2004 |
| Date of final enrolment | 01/09/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
VU University Medical Centre
Amsterdam
1081 BT
Netherlands
1081 BT
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 01/08/2008 | Yes | No |
