| - candidate number | 2552 |
| - NTR Number | NTR957 |
| - ISRCTN | ISRCTN91626621 |
| - Date ISRCTN created | 30-mei-2007 |
| - date ISRCTN requested | 22-mei-2007 |
| - Date Registered NTR | 16-apr-2007 |
| - Secondary IDs | |
| - Public Title | Expert patiënts as a coach in a selfmanagementprogram for newly diagnosed patients with diabetes type 2: a randomised controlled trial |
| - Scientific Title | Expert patiënts as a coach in a selfmanagementprogram for newly diagnosed patients with diabetes type 2: a randomised controlled trial |
| - ACRONYM | DIO |
| - hypothesis | Selfmanagement coaching by an expert patient leads to more control and better quality of life in newly diagnosed patients with diabetes type 2. Selfmanagement coaching by an expert patient leads to better coping in newly diagnosed patients with diabetes type 2 Selfmanagement coaching by an expert patient leads to better quality of care in newly diagnosed patients with diabetes type 2 |
| - Healt Condition(s) or Problem(s) studied | Diabetes Mellitus type 2 (DM type II), Quality of Health Care, Quality of life, Expert patients, Selfmanagement, Self-efficacy |
| - Inclusion criteria | 1. Patients with diabetes type 2; 2. Good understanding of Dutch language |
| - Exclusion criteria | 1. Impaired cognitive function belonging to minority group for which separate intervention is needed (Turkish, Maroccon, etc.) |
| - mec approval received | no |
| - multicenter trial | no |
| - randomised | yes |
| - masking/blinding | Single |
| - control | Active |
| - group | Parallel |
| - Type | - |
| - Studytype | intervention |
| - planned startdate | 15-sep-2007 |
| - planned closingdate | 1-apr-2009 |
| - Target number of participants | 200 |
| - Interventions | Selfmanagement coaching by an expert patient: patient-tailored information and counseling about diabetes and its consequenses 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 3 months. A selfmanagement 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, 3 and 6 months after the intervention, all patients complete a questionnaire about quality of life, quality of care, self-efficacy, selfmanagement behaviour and coping. |
| - Primary outcome | Self-efficacy |
| - Secondary outcome | 1. Quality of life; 2. Coping; 3. Selfmanagement behaviour; 4. Quality of care |
| - Timepoints | |
| - Trial web site | |
| - status | planned |
| - CONTACT FOR PUBLIC QUERIES | Dr. J.R.J. Leeuw, de |
| - CONTACT for SCIENTIFIC QUERIES | Dr. J.R.J. Leeuw, de |
| - Sponsor/Initiator | University Medical Center Utrecht (UMCU), Julius Center, Nursing Sciences |
| - Funding (Source(s) of Monetary or Material Support) | Diabetes Research Fund |
| - Publications | |
| - Brief summary | Recently diagnosed patients with diabetes type 2 are confronted with many new selfmanagement tasks and guidelines regarding lifestyle and coping with their disease. The main purpose of this study is to investigate if selfmanagement coaching by expert patients leads to more perceived control over diabetes and better quality of life in newly diagnosed patients with diabetes type 2. 200 patients that are 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 3 months. A selfmanagement 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, 3 and 6 months after the intervention, all patients complete a questionnaire about quality of life, quality of care, self-efficacy, selfmanagement behaviour and coping. It is expected that the intervention will result in more self-efficacy, better selfmanagement, better quality of life, less depressive symptoms and a better quality of care as compared with patients only receiving usual care. |
| - Main changes (audit trail) | |
| - RECORD | 16-apr-2007 - 11-jun-2007 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl