Behavioral problems in nursing residents with dementia.|
|- candidate number||6805|
|- NTR Number||NTR2141|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||11-dec-2009|
|- Secondary IDs||171002212 ZonMW|
|- Public Title||Behavioral problems in nursing residents with dementia.|
|- Scientific Title||Managing behavioral problems in nursing home residents with dementia.|
|- hypothesis||Of major concern in dementia are accompanying behavioral problems. Clinically relevant behavioral problems (aggression, agitation, apathy) occur frequently and are mostly chronical. They result in considerable distress and workload for nursing staff, are associated with high costs and with a diminished quality of life.|
This study investigates the cost effectiveness of an evidence and practice based care program for multidisciplinary teams to detect, analyze and treat behavior problems in nursing home residents with dementia and to evaluate treatment effects.
It is hypothesized that the care program will result in less behavioral problems,less distress for care personnel and less costs and also will improve quality of life.
|- Healt Condition(s) or Problem(s) studied||Dementia, Behavioural disorders|
|- Inclusion criteria||Nursing home residents with dementia residing on dementia special care units.|
|- Exclusion criteria||Refusal to participate.|
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-feb-2011|
|- planned closingdate||30-sep-2012|
|- Target number of participants||280|
|- Interventions||Intervention: |
Evidence and practice based care program for management of behavioral problems in nursing home residents with dementia.
(the care program includes an evidence based standardisation of the phases in the management of BP: detection, analysis, treatment and evaluation. Cooperation between disciplines is prearranged.
A general training of nursing staff about all phases of management of behavioral problems is the starting point. The care program itself is directed at specific behavioral problems of individual nursing home residents with specific analysis and specific interventions, followed by a close monitoring of treatment effects.)
Usual care for behavioral problems in nursing home residents with dementia.
|- Primary outcome||Prevalence of behavioral problems (CMAI).|
|- Secondary outcome||1. Quality of life (EuroQol: EQ5D, by proxy version);|
2. Prescription rate of antipsychotics;
3. Use of restraints;
4. Workload nursing staff (Utrecht Burnout Scale);
5. Jobsatisfaction nursing staff (Leiden Quality of Work Questionnaire).
|- Timepoints||1. Behavioral problems: measured at 0, 4,8, 12, 16 and 20 months: total score on CMAI;|
2. Quality of life: score on EQ-5D by proxy version, measured at 0, 4,8, 12, 16 and 20 months;
3. Prescription rate of antipsychotics: % of residents using an antipsychotic measured at at 0, 4,8, 12, 16 and 20 months;
4. Use of restraints: % of residents using a restraint measured at at 0, 4,8, 12, 16 and 20 months;
5. Workload nursing staff: score on Utrecht Burnout scale, measured at 0, 12 and 20 months;
6. Jobsatisfaction nursing staff: score on Leiden Quality of Work Questionnaire, measured at 0, 12 and 20 months.
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||Dr. Martin Smalbrugge|
|- CONTACT for SCIENTIFIC QUERIES||Dr. Martin Smalbrugge|
|- Sponsor/Initiator ||VU University Medical Center, EMGO Institute|
(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, care program 'managing behavior problems (BPs) in nursing home (NH) residents with dementia'.
A longitudinal controlled study on 14 dementia special care units in the Netherlands that, in a stepped wedge design, all will implement the program.
Study population: all patients on participating units.
Intervention: evidence based standardization of the management of BP in NH residents with dementia, including standardized use of measurement instruments, a standardized method of analysis, and individually tailored psychosocial, psychological and pharmacological treatment according to protocol.
Prevalence of behavioral problems (CMAI); quality of life (EQ-5D).
Sample size calculation/data analysis:
Sample size: 6 measurements on 14 dementia special care units (each with 20 residents on average) are needed (assumptions: BP prevalence 80%, effect 10 points decrease CMAI-score, almost no attrition, alpha 0.05, power 0.80, ICC 0.1).
Data analysis: primary effects will be calculated using multilevel linear and logistic regression analyses. Prescription rate of antipsychotics and the EQ5D will be used in the primary analysis. Secondary analyses will include: prescription rate of antipsychotics; workload (burnout) and job satisfaction of nursing staff; use of restraints.
Economic evaluation: From a healthcare perspective, two ICERs will be calculated for costs per: 1 one point decrease in CMAI-score; 2) one QALY increase.
Time schedule: 48 months (21 months data collection).
|- Main changes (audit trail)|
|- RECORD||11-dec-2009 - 18-dec-2009|
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