The evaluation of a careprogram to increase the detection and treatment of depression in nursing homes|
|- candidate number||4173|
|- NTR Number||NTR1477|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||3-okt-2008|
|- Secondary IDs||170992801 ZonMw projectnumber|
|- Public Title||The evaluation of a careprogram to increase the detection and treatment of depression in nursing homes|
|- Scientific Title||The evaluation of a careprogram to increase the detection and treatment of depression in nursing homes|
|- hypothesis||Research question: From a healthcare perspective, is careprovision according to the careprogram ‘Doen bij Depressie’ more efficient than usual care with regard to the management of depression and the quality of life of nursing home patients?
|- Healt Condition(s) or Problem(s) studied||Depression, Nursing home|
|- Inclusion criteria||1. All patients from 14 somatic and 14 dementia units of Dutch nursing homes|
|- Exclusion criteria||None|
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jun-2009|
|- planned closingdate||31-dec-2011|
|- Target number of participants||560|
|- Interventions||The multifaceted and multidisciplinary careprogram ‘Doen bij Depressie’ [Act in case of depression] starts with a training program for nursing staff on how to identify symptoms of depression using an observation scale (Hammond, 2000) and how to support NH patients with depressive symptoms or depression in close collaboration with the NH’s psychologist. In a recent review Llewellyn-Jones et al. (2007) concluded that psychosocial and environmental interventions are important in all types of depression and may prove to be even more effective than the use of antidepressants. |
Further, it comprises plans of work for the identification, screening, diagnosing, treatment and monitoring of depression.
|- Primary outcome||1. Frequency of depression: the percentage of patients with depression on a unit Somatic units: |
- Geriatric Depression Scale (GDS)(Yesavage et al., 1983) In this study we use the 8-item GDS-NH version of Jongenelis et al. (2007), which was made by deleting GDS-items that are not applicable to most NH patients.
- Cornell Scale for Depression in Dementia (CSDD)(Alexopoulos et al., 1988)
2. Quality of life Somatic units:
- EQ-5D (EuroQol group, 1999).
- EQ-5D proxy version (Jönsson et al., 2006)
|- Secondary outcome||- Response to treatment of depressed patients, using the GDS (somatic) or Cornell (dementia units) scale. |
- Percentage accuracy of detection of depression in usual care, using the units’ patient files.
- Diagnostic interview and physical exam by unit’s psychologist and physician, using DSM-IV depression criteria for somatic patients (APA, 1994), and Olin’s depression criteria for dementia patients (Olin et al., 2002).
Cognition: Mini Mental State Examination (MMSE) (Folstein et al., 1975).
Patient files will be checked for sociodemographic variables, mental health history (including prior depressive episode) and present condition (including a dementia diagnosis and possible treatment for depression) as known by the institution.
|- Timepoints||The study proposed is a stepped wedge, multicentre intervention study on 14 somatic and 14 dementia units of UVNN-NH.|
A stepped wedge design is a type of crossover design in which different clusters (here: units) cross over from control to intervention at different time points.
All clusters are measured at each time point. The first time point corresponds to a baseline measurement where none of the clusters receive the intervention of interest, at the last time point all clusters receive the intervention.
After intermediate time points, clusters initiate the intervention.
At the start of the data collection, all patients of all 28 units will be screened for depression (T0).
Following this, each of the units will be randomly assigned to one of 5 groups. Each group will start the intervention at different time points, directly after one of the measurements (T0-T4), which are each 4 months apart. In the four- month interval between T0 and T1, nursing staff of the first group (6 units) will be trained within the first month. After this month, the intervention runs for the subsequent 3 months in the first group before the second measurement (T1) of all 28 units takes place.
After T1, the second group (6 units) will be trained, and the intervention will be started in this group (and continue in the first group).
This procedure will be repeated for the remaining 3 groups (6 units after T2, 6 units after T3 and 4 units after T4), until at the last measurement (T5) all 28 units will be measured as they are in the intervention condition.
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||Mw. Dr. D.L. Gerritsen|
|- CONTACT for SCIENTIFIC QUERIES||Mw. Dr. D.L. Gerritsen|
|- Sponsor/Initiator ||University Medical Center St. Radboud|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||Objective: |
To quantify cost-effectiveness of a multidisciplinary, guideline based, careprogram for detection and treatment of depression in nursing homes.
A longitudinal controlled study on 14 somatic and 14 dementia units that, in a stepped wedge design, all will implement the program.
All patients on participating units.
Evidence based standardization of the management of depression, including standardized use of measurement instruments and diagnostical methods, and psychosocial, psychological and pharmacological treatment according to protocol.
Frequency of depression on unit; quality of life (EQ-5D).
Power analysis: 6 measurements on 14 somatic units are needed (based on: prevalence 22%, effect 40%, maximum attrition rate 20%, alpha 0.05, power 0.80, ICC 0.1). 6 measurements on 14 dementia units are needed (prevalence 30%, effect 35%, almost no attrition, alpha 0.05, power 0.80, ICC 0.1).
From a healthcare perspective, two ICERs will be calculated for costs per:
1) percentage point decrease in frequency of depression.
2) one QALY increase.
|- Main changes (audit trail)|
|- RECORD||3-okt-2008 - 12-okt-2008|
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