Contact information
Type
Scientific
Primary contact
Dr J.R.J. de Leeuw
ORCID ID
Contact details
University Medical Centre Utrecht (UMCU)
Department of Nursing Science
P.O. Box 80036
Utrecht
3508 TA
Netherlands
+31 (0)30 2538879
j.r.j.deleeuw@umcutrecht.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
DIO
Study hypothesis
1. Self-management coaching by an expert patient leads to more control and better quality of life in newly diagnosed patients with diabetes type two
2. Self-management coaching by an expert patient leads to better coping in newly diagnosed patients with diabetes type two
3. Self-management coaching by an expert patient leads to better quality of care in newly diagnosed patients with diabetes type two
Ethics approval
Not provided at time of registration
Study design
Randomised, single blinded, active controlled, parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Quality of life
Patient information sheet
Condition
Diabetes Mellitus type 2
Intervention
Self-management coaching by an expert patient:
Patient-tailored information and counselling about diabetes and its consequences for functioning and lifestyle.
200 patients, included in the study within one year, will be randomised and stratified for sex.
Patients in the experimental group (N = 100) are coached by an expert patient for three months. A self-management program is used with a focus on diet and physical activity. The coaching is given additional to the usual care by the general practitioner, dietician and diabetic nurse.
Before, three and six months after the intervention, all patients complete a questionnaire about quality of life, quality of care, self-efficacy, self-management behaviour and coping.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Self-efficacy.
Secondary outcome measures
1. Quality of life
2. Coping
3. Self-management behaviour
4. Quality of care
Overall trial start date
15/09/2007
Overall trial end date
01/04/2009
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients with diabetes type two
2. Good understanding of Dutch language
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
200
Participant exclusion criteria
1. Impaired cognitive function
2. Belonging to minority group for which separate intervention is needed (Turkish, Moroccan, etc.)
Recruitment start date
15/09/2007
Recruitment end date
01/04/2009
Locations
Countries of recruitment
Netherlands
Trial participating centre
University Medical Centre Utrecht (UMCU)
Utrecht
3508 TA
Netherlands
Sponsor information
Organisation
University Medical Centre Utrecht (UMCU) (The Netherlands)
Sponsor details
Julius Centre
Nursing Sciences
P.O. Box 85500
Utrecht
3508 GA
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Research organisation
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