|- candidate number||8041|
|- NTR Number||NTR2314|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||4-mei-2010|
|- Secondary IDs||171002502 / 2010/147 ; ZonMw / CMO|
|- Public Title||An study of effectiveness of Dementia Care Mapping intervention in nursing home settings.|
|- Scientific Title||An RCT study of (cost)effectiveness of Dementia Care Mapping intervention in nursing home settings.|
|- hypothesis||The main objective of the present study is to evaluate (cost)effectiveness of Dementia Care Mapping (DCM)intervention in nursing home dementia care by performing a large RCT study.|
|- Healt Condition(s) or Problem(s) studied||Dementia|
|- Inclusion criteria||1. 65-up years old;|
2. Diagnosed with dementia by a (psycho)geriatrician, neurologist or old age psychiatrist/psychologist
3. Who have received an assent by the nursing home physician;
4. Who display at least one neuropsychiatric symptom (CMAI, NPI-NH) such as agitation/agression, apathy, verbal and physical aggression, severe vocal and physical perseveration, significant wandering and self-harm;
5. Who have either provided informed consent themselves or by their family/legal guardian.
|- Exclusion criteria||Residents who are in a terminal stage of the illness (estimated life expectancy 6 weeks) or those who are too physically unwell to spend time in common areas of the facility, will not be included in the study.|
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jul-2010|
|- planned closingdate||1-mrt-2013|
|- Target number of participants||280|
|- Interventions||Intervention group:|
1. Dementia Care Mapping (DCM) Organisational Briefing Day;
2. Staff trainings (Certified DCM User);
3. Three DCM-cycles (single cycle: observation, feed-back, development and implementation of action plan(s), evaluation actions).
1. Usual Care.
|- Primary outcome||Residents:|
1. Neuropsychiatric symptoms (CMAI, NPI-NH).
|- Secondary outcome||Residents:|
1. Quality of life (WIB, DQol).
1. Work-stress (GHQ);
2. Stress related absenteeism and turnover;
3. Job satisfaction (MAS, VAS).
|- Timepoints||All outcomes are measured 4 times, starting oktober 2010 with 4 months between every measurement.|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Drs. G. Ven, van de|
|- CONTACT for SCIENTIFIC QUERIES||Drs. G. Ven, van de|
|- 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||Effectiveness and efficiency of nursing home dementia care is sub-optimal with high levels of resident neuropsychiatric symptoms and staff work stress. The main objective of the present study is to evaluate (cost)effectiveness of Dementia Care Mapping (DCM) in nursing home dementia care by performing a large scale RCT study. DCM is a method by which person centred care can be integrated in all facets of nursing home dementia care. There is a strong evidence that person centred care may alleviate both the resident and the staff problems.|
|- Main changes (audit trail)|
|- RECORD||4-mei-2010 - 5-aug-2010|