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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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28 April 2013 |
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Main ID: |
NTR835 |
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Date of registration:
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11/12/2006 |
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Primary sponsor: |
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Public title:
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PRoactive Management Of Depression in the Elderly.
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Scientific title:
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Effects and costs of a combined screening and treatment program for elderly (aged 75 years and over) with depressive symptoms in general practice. - PROMODE |
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Date of first enrolment:
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1/3/2007 |
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Target sample size:
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4000 |
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Recruitment status: |
pending |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=835 |
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Study type:
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intervention |
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Study design:
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Randomised: Yes; Masking: None; Control: Not applicable; Group: Parallel; Type: -
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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G.M.
Weele, van der |
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Address:
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Leiden University Medical Center (LUMC), Department of Public Health and Primary Care,
P.O. Box 9600
2300 RC
Leiden
The Netherlands |
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Telephone:
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+31 (0)71 5268444 |
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Email:
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G.M.van_der_Weele@lumc.nl |
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Affiliation:
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Name:
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J.
Gussekloo |
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Address:
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Leiden University Medical Center (LUMC), Department of Public Health and Primary Care,
P.O. Box 9600
2300 RC
Leiden
The Netherlands |
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Telephone:
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+31 (0)71 5268444 |
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Email:
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J.Gussekloo@lumc.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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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).
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Depressive symptoms
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Intervention(s)
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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.
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Primary Outcome(s)
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Difference in severity of depressive symptoms (MADRS baseline - 6 months).
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Secondary Outcome(s)
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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.
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Secondary ID(s)
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ISRCTN71142851
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N/A
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Source(s) of Monetary Support
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ZON-MW, The Netherlands Organization for Health Research and Development
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