| - candidate number | 2363 |
| - NTR Number | NTR835 |
| - ISRCTN | ISRCTN71142851 |
| - Date ISRCTN created | 16-jan-2007 |
| - date ISRCTN requested | 29-dec-2006 |
| - Date Registered NTR | 11-dec-2006 |
| - Secondary IDs | N/A |
| - Public Title | PRoactive Management Of Depression in the Elderly. |
| - Scientific Title | Effects and costs of a combined screening and treatment program for elderly (aged 75 years and over) with depressive symptoms in general practice. |
| - ACRONYM | PROMODE |
| - hypothesis | A screening and stepped care treatment program for elderly with depressive symptoms in general practice will lead to significant reduction of depressive symptoms and costs in comparison to CAU. |
| - Healt Condition(s) or Problem(s) studied | Depressive symptoms |
| - Inclusion criteria | 1. Inclusion criteria for screening: elderly aged 75 years and over enlisted in general practices; 2. Inclusion criteria for treatment-offer: screen positive for depression (GDS-15 > 4). |
| - Exclusion criteria | 1. Exclusion criteria for screening: terminal illness, current treatment for depression, loss of partner/important relative within previous 3 months; 2. Exclusion criteria for treatment-offer: severe cognitive impairment (MMSE < 19). |
| - mec approval received | no |
| - multicenter trial | yes |
| - randomised | yes |
| - masking/blinding | None |
| - control | Not applicable |
| - group | Parallel |
| - Type | - |
| - Studytype | intervention |
| - planned startdate | 1-mrt-2007 |
| - planned closingdate | 1-mrt-2009 |
| - Target number of participants | 4000 |
| - Interventions | In the intervention practices elderly with depressive symptoms will be offered a stepped care treatment program, including 1) individual counselling by a community psychiatric nurse 2) psycho-education by a Coping with Depression group course or a similar therapy on individual basis, and 3) pharmacological treatment and/or referral for patients with persistence of depressive symptoms after step 1 and 2. In the control practices elderly will receive care as usual. |
| - Primary outcome | Difference in severity of depressive symptoms (MADRS baseline - 6 months). |
| - Secondary outcome | Differences (at 6 and 12 months) in: 1. Percentage responders to treatment; 2. Quality of life (SF-36, EQ-5D); 3. Mortality; 4. Use of (in)formal help or home care; 5. Medical consumption; 6. Cost-effectiveness; 7. Costs per QALY. |
| - Timepoints | |
| - Trial web site | N/A |
| - status | planned |
| - CONTACT FOR PUBLIC QUERIES | Drs. G.M. Weele, van der |
| - CONTACT for SCIENTIFIC QUERIES | Dr. J. Gussekloo |
| - Sponsor/Initiator | Leiden University Medical Center (LUMC), Department of Public Health and Primary Care |
| - Funding (Source(s) of Monetary or Material Support) | ZON-MW, The Netherlands Organization for Health Research and Development |
| - Publications | N/A |
| - Brief summary | We aim to study the effects and costs of a screening and treatment program for elderly with depressive symptoms in general practice. The design is a pragmatic cluster randomised controlled trial with the general practice as the unit of randomisation. Elderly aged 75 years and over enlisted in general practices will be screened at baseline for depressive symptoms, measured by the Geriatric Depression Scale (GDS-15). If GDS-15 score is > 4 points intervention or usual care will be offered according to the allocated treatment to their general practice. |
| - Main changes (audit trail) | |
| - RECORD | 11-dec-2006 - 19-jan-2007 |
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