search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


PRoactive Management Of Depression in the Elderly.


- candidate number2363
- NTR NumberNTR835
- ISRCTNISRCTN71142851
- Date ISRCTN created16-jan-2007
- date ISRCTN requested29-dec-2006
- Date Registered NTR11-dec-2006
- Secondary IDsN/A 
- Public TitlePRoactive Management Of Depression in the Elderly.
- Scientific TitleEffects and costs of a combined screening and treatment program for elderly (aged 75 years and over) with depressive symptoms in general practice.
- ACRONYMPROMODE
- hypothesisA 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) studiedDepressive symptoms
- Inclusion criteria1. 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 criteria1. 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 receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 1-mrt-2007
- planned closingdate1-mrt-2009
- Target number of participants4000
- InterventionsIn 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 outcomeDifference in severity of depressive symptoms (MADRS baseline - 6 months).
- Secondary outcomeDifferences (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 siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDrs. G.M. Weele, van der
- CONTACT for SCIENTIFIC QUERIESDr. 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
- PublicationsN/A
- Brief summaryWe 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)
- RECORD11-dec-2006 - 19-jan-2007


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl