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 |
| Protocol serial number | N/A |
| Sponsor | University Medical Centre Utrecht (UMCU) (The Netherlands) |
| Funder | Diabetes Research Fund (The Netherlands) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, single blinded, active controlled, parallel group trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Self-efficacy. |
| Key secondary outcome measure(s) |
1. Quality of life |
| Completion date | 01/04/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 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
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 | 01/10/2012 | 06/08/2021 | Yes | No |
Editorial Notes
06/08/2021: Publication reference and total final enrolment added.
