PROactive Management Of Depression in the Elderly
| ISRCTN | ISRCTN71142851 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN71142851 |
| Protocol serial number | N/A |
| Sponsor | Leiden University Medical Center (LUMC) (Netherlands) |
| Funder | The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands) |
- Submission date
- 16/01/2007
- Registration date
- 16/01/2007
- Last edited
- 22/03/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr G M van der Weele
Scientific
Scientific
Leiden University Medical Center (LUMC)
Department of Public Health and Primary Care
P.O. Box 9600
Leiden
2300 RC
Netherlands
| Phone | +31 (0)71 526 8444 |
|---|---|
| G.M.van_der_Weele@lumc.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Pragmatic cluster randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | PROMODE |
| Study objectives | 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 Care As Usual (CAU). |
| Ethics approval(s) | Approval received from the Medical Ethics Committee of the Leiden University Medical Centre (Commissie medische ethiek van het Leids Universitair Medisch Centrum [LUMC]) on the 27th February 2007. We also received a letter of approval from the Raad van Bestuur (Board of Directors) of the LUMC. |
| Health condition(s) or problem(s) studied | Depressive symptoms |
| Intervention | 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. |
| Intervention type | Other |
| Primary outcome measure(s) |
Difference in severity of depressive symptoms (Montgomery Asberg Depression Rating Scale [MADRS] baseline - six months). |
| Key secondary outcome measure(s) |
Differences (at six and 12 months) in: |
| Completion date | 01/03/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | All |
| Target sample size at registration | 4000 |
| Key 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 (Geriatric Depression Scale [GDS-15] more than four) |
| Key exclusion criteria | 1. Exclusion criteria for screening: terminal illness, current treatment for depression, loss of partner/important relative within previous three months 2. Exclusion criteria for treatment-offer: severe cognitive impairment (Mini Mental State Examination [MMSE] less than 19) |
| Date of first enrolment | 01/03/2007 |
| Date of final enrolment | 01/03/2009 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Leiden University Medical Center (LUMC)
Leiden
2300 RC
Netherlands
2300 RC
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 | results | 01/03/2011 | Yes | No | |
| Results article | results | 01/07/2012 | Yes | No |
