|- candidate number||2865|
|- NTR Number||NTR1122|
|- ISRCTN||Geen aanvraag/Observational study|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||7-nov-2007|
|- Secondary IDs||incomplete |
|- Public Title||Small scale living facilities for older people with dementia.|
|- Scientific Title||Effects of small scale living facilities for older people with dementia on residents' quality of life and functioning, family caregivers' burden, care satisfaction, and professional caregivers' job satisfaction. |
|- hypothesis||It is hypothesized that residents in small scale living facilities, compared to those in regular nursing home care, have a higher quality of life and functioning. In addition, it is hypothesized that their family caregivers experience less burden and have a higher care satisfaction. Profesional caregivers are expected to have a higher job satisfaction. |
|- Healt Condition(s) or Problem(s) studied||Dementia|
|- Inclusion criteria||Psychogeriatric residents living in regular nursing homes or in small scale living facilities with the (probable) diagnosis dementia, their family caregivers and professional caregivers.|
|- Exclusion criteria||1. Residents in a terminal disease stage, who are expected being transferred within 6 months;|
2. Residents who live less than 4 months in the facility;
3. Korsakov or other psychiatric diseases except for dementia.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||1-feb-2008|
|- planned closingdate||1-okt-2009|
|- Target number of participants||200|
|- Interventions||Small scale living facilities have a maximum of 8 residents per house or unit. Residents and professional caregivers form a household: activities of daily life are central and they cook together. Professional caregivers have integrated tasks: e.g. personal/medical care, cooking, cleaning, activities. Residents and family care givers have a large amount of control over their daily life. In addition, the physical setting resembles a homelike, archetype house and household.
Control group: regular psychogeriatric wards in a large nursing home, with 15 ore more residents per ward. Professional caregivers have differentiated tasks: they only provide personal and medical care. Residents and family caregivers have little control over the daily life: this is largely determined by the nursing home's organisation.|
|- Primary outcome||Residents: quality of life. |
Family caregivers: care burden, satisfaction and involvement with care and wellbeing.
Professional caregivers: job satisfaction.
|- Secondary outcome||Residents: behavioral problems, ADL, Cognition, Mood, Social functioning, use of physical restraints, use of heath care services, weight, psychofarmaca
Family caregivers: sense of competence
Professional caregivers: workload, autonomy, social support.
|- Timepoints||3 measurements: baseline, after 6 months (T1) and after 1 year (T2).|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||MSc Hilde Verbeek,|
|- CONTACT for SCIENTIFIC QUERIES||MSc Hilde Verbeek,|
|- Sponsor/Initiator ||University Hospital Maastricht (AZM)|
(Source(s) of Monetary or Material Support)
|University Maastricht (UM), MeanderGroep Zuid-Limburg, Orbis Medisch en Zorgcentrum|
|- Brief summary||In dementia care, interest has been raised in small, domestic style care settings. The effects of these small-scale living facilities are not clear yet. Positive as well as negative influences have been suggested. The aim of the current study is to examine the effects of small-scale living arrangements on residents, family caregivers and professional caregivers.
A longitudinal quasi-experiment study is carried out in the south of the Netherlands (2008-2010). The intervention consists of small-scale living arrangements, regular nursing home care is the control condition. Residents (n=200), family caregivers (n=160) and professional caregivers (n=300) are compared on several outcome measures. The primary outcome measure for residents is quality of life; in addition behavioral problems, medication, functional status and use of physical restraints are measured. Family caregivers are compared on involvement with care, care burden and health. Job satisfaction is the primary outcome measure for professional caregivers; secondary measures include health status and autonomy. Measurements are performed at baseline, after 6 and 12 months.
|- Main changes (audit trail)|
|- RECORD||7-nov-2007 - 12-nov-2008|