|- candidate number||13199|
|- NTR Number||NTR3569|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||2-aug-2012|
|- Secondary IDs||4041600989025 ZonMw|
|- Public Title||PRescription Optimization of Psychotropic drugs in Elderly nuRsing home patients with dementia (PROPER study).|
|- Scientific Title||PRescription Optimization of Psychotropic drugs in Elderly nuRsing home patients with dementia.|
|- ACRONYM||PROPER study|
|- hypothesis||The intervention increases the frequency of appropriate psychotropic medication use.|
|- Healt Condition(s) or Problem(s) studied||Psychotropic medication, Nursing home, Dementia|
|- Inclusion criteria||All or a random selection of at least 15 nursing home patients of dementia special care units participating in the study.|
|- Exclusion criteria||Objection to participation in this study.|
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-sep-2012|
|- planned closingdate||31-jul-2014|
|- Target number of participants||360|
|- Interventions||Structured, 6-monthly medication review including training/education, control is usual care.
Nursing homes randomized to the intervention group, will implement a structured and repeated medication review. This comprises training on the implementation of medication reviews, and the actual conduct of the medication reviews per individual patient. The training consists of four sessions: a kick-off meeting, a medication review course and two evaluation sessions. The training will be given by the Dutch Institute for Rational Use of Medicine (IVM). Medication reviews are conducted shortly after the 0, 6, and 12-month assessments and subsequent training sessions. In the medication reviews, the pharmacist, physician and nurse will discuss all medication of the individual patients. In nursing homes randomized to the control group, usual care is continued.
|- Primary outcome||Prevalence of patients with appropriate psychotropic medication use.|
|- Secondary outcome||Neuropsychiatric symptoms: |
Neuropsychiatric Inventory-Questionaire (NPI-Q), Cohen-Mansfield Agitation Inventory (CMAI), Nijmegen Observer-Rated Depression scale (NORD), Depression Rating Scale (DRS).
Quality of life:
Qualidem, Revised Index Social Engagement (RISE).
Activities of daily living:
Minimum Data Set-Activities of Daily Living-Self-Performance Hierarchy (MDS-ADL-SPH).
Short Side effect Scale for Psychotropic Drugs (3SPD).
Severe Impairment Battery-8 (SIB-8).
|- Timepoints||0, 6, 12, and 18 months.|
|- 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||In this cluster randomised controlled pragmatic trial, the effect of a structured, 6-monthly medication review including training/education compared to usual care is studied in nursing home patients with dementia. The intervention is expected to improve appropriate psychotropic drug use and quality of life, and to decrease adverse events without increasing neuropsychiatric symptoms. The study is conducted in 26 dementia special care units of 13 nursing homes throughout the Netherlands.|
|- Main changes (audit trail)|
|- RECORD||2-aug-2012 - 25-sep-2012|