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
Secondary identifying numbers	Diabetes Research Fund: 2003.00.020; NTR149

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

VU University Medical Centre
Medical Psychology
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands

Phone	+31 (0)20 444 8420
Email	m.dewit@vumc.nl

Study information

Study design	Multicentre, randomised, active controlled crossover trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
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	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 study start date	01/09/2004
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 number of participants	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

Sponsor information

Vrije University Medical Centre (VUMC) (The Netherlands)
University/education

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

Website	http://www.vumc.nl
"ROR"	https://ror.org/00q6h8f30

Funders

Funder type

Charity

Diabetes Research Fund (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	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