Expert patients as a coach in a self-management program for newly diagnosed patients with diabetes type two: a randomised controlled trial
| ISRCTN | ISRCTN91626621 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN91626621 |
| Secondary identifying numbers | N/A |
- Submission date
- 30/05/2007
- Registration date
- 30/05/2007
- Last edited
- 06/08/2021
- 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 J.R.J. de Leeuw
Scientific
Scientific
University Medical Centre Utrecht (UMCU)
Department of Nursing Science
P.O. Box 80036
Utrecht
3508 TA
Netherlands
| Phone | +31 (0)30 2538879 |
|---|---|
| j.r.j.deleeuw@umcutrecht.nl |
Study information
| Study design | Randomised, single blinded, active controlled, parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Quality of life |
| Scientific title | Expert patients as a coach in a self-management program for newly diagnosed patients with diabetes type two: a randomised controlled trial |
| Study acronym | DIO |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | Self-efficacy. |
| Secondary outcome measures | 1. Quality of life 2. Coping 3. Self-management behaviour 4. Quality of care |
| Overall study start date | 15/09/2007 |
| Completion date | 01/04/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 200 |
| Total final enrolment | 133 |
| Key inclusion criteria | 1. Patients with diabetes type two 2. Good understanding of Dutch language |
| Key exclusion criteria | 1. Impaired cognitive function 2. Belonging to minority group for which separate intervention is needed (Turkish, Moroccan, etc.) |
| Date of first enrolment | 15/09/2007 |
| Date of final enrolment | 01/04/2009 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Medical Centre Utrecht (UMCU)
Utrecht
3508 TA
Netherlands
3508 TA
Netherlands
Sponsor information
University Medical Centre Utrecht (UMCU) (The Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Julius Centre
Nursing Sciences
P.O. Box 85500
Utrecht
3508 GA
Netherlands
| Website | http://www.juliuscentrum.nl/julius/ |
|---|---|
"ROR" |
https://ror.org/04pp8hn57 |
Funders
Funder type
Research organisation
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 | 01/10/2012 | 06/08/2021 | Yes | No |
Editorial Notes
06/08/2021: Publication reference and total final enrolment added.
