PROactive Management Of Depression in the Elderly
| ISRCTN | ISRCTN71142851 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN71142851 |
| Secondary identifying numbers | N/A |
- 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
| Study design | Pragmatic cluster randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Screening |
| 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 | Difference in severity of depressive symptoms (Montgomery Asberg Depression Rating Scale [MADRS] baseline - six months). |
| Secondary outcome measures | Differences (at six and 12 months) in: 1. Percentage responders to treatment 2. Quality of life (Short Form health survey [SF-36], EuroQol questionnaire [EQ-5D]) 3. Mortality 4. Use of (in)formal help or home care 5. Medical consumption 6. Cost-effectiveness 7. Costs per Quality Adjusted Life Year (QALY) |
| Overall study start date | 01/03/2007 |
| Completion date | 01/03/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 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
Sponsor information
Leiden University Medical Center (LUMC) (Netherlands)
Hospital/treatment centre
Hospital/treatment centre
Department of Public Health and Primary Care
P.O. Box 9600
Leiden
2300 RC
Netherlands
| Website | http://www.lumc.nl/ |
|---|---|
"ROR" |
https://ror.org/05xvt9f17 |
Funders
Funder type
Research organisation
The Netherlands Organisation for Health Research and Development (ZonMw) (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 | results | 01/03/2011 | Yes | No | |
| Results article | results | 01/07/2012 | Yes | No |
