The pros and cons of small-scale living for elderly people suffering from dementia in the Netherlands and Belgium

ISRCTN	ISRCTN23772945
DOI	https://doi.org/10.1186/ISRCTN23772945
Protocol serial number	N/A
Sponsor	University of Tilburg (Netherlands) - Department Tranzo
Funder	University of Tilburg (Netherlands) - Department Tranzo

Submission date: 29/04/2010
Registration date: 12/05/2010
Last edited: 03/04/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Ms Ietje de Rooij
Scientific

Care Centre De Kievitshorst
Beneluxlaan 101
Tilburg
5042WN
Netherlands

Study information

Primary study design	Observational
Study design	Multicentre cross-national longitudinal qualitative study
Secondary study design	Cohort study
Study type	Participant information sheet
Scientific title	Perspectives on the results of small-scale living facilities in the Netherlands and Belgium
Study objectives	What is the effect of living in a small-scale facility compared to living in a traditional care ward on patient outcomes, including quality of life, for elderly people suffering from dementia?
Ethics approval(s)	1. Ethics committee of the University of Tilburg approved in April 2007 2. Ethics committee of De Wever approved in April 2007
Health condition(s) or problem(s) studied	Severe dementia
Intervention	Participants will be followed for a year during their stay at a closed-environment dementia care ward. They were not assigned a kind of ward by the researchers. At three points during the study (the beginning, after six months, after a year) participants will fill out the Standardized Mini Mental State Examination with the help of a psychologist, care givers will provide information on quality of life measures, activities of daily living, depression, neuropsychatric symptoms and social engagement. The family will provide information about the quality of the care received at the start and end of the study. The participating care giving staff will provide information about their workload and work experiences at the start and the end of the study.
Intervention type	Other
Primary outcome measure(s)	1. Quality of life, assessed by Quality of Life in Dementia (QUALIDEM) 2. Activities of daily living (ADL), assessed by Barthel Index 3. Depression, assessed by Cornell Scale for Depression in Dementia (CSDD) 4. Neuropsychiatric symptoms, assessed by Neuropsychiatric Inventory, Nursing Home Version (NPI-NH) 5. Social engagement, assessed by Revised Index of Social Engagement (RISE) taken from the Resident Assessment Instrument (RAI 2.0) All outcomes were measured at baseline (i.e. start of study), 6 months and one year. All questionnaires used were in the Dutch language.
Key secondary outcome measure(s)	1. Control measures: 1.1. Severity of dementia, assessed by Standardized Mini Mental State Examination (S-MMSE) 1.2. Medications falling in the category antipsychotics, antidepressants and sedatives were 1.3. Restriction measures, kind of measure and number of measures were noted 1.4. Visitors, a single question was answered how many times a month the patient gets a visit from family or friends 1.5. Weight, registered fully clothed and with shoes on 2. Family: 2.1. Quality of care 2.2. Interactive activities with their loved one The questionnaire they received was designed by the researchers themselves. A copy can be requested through the contact details below. 3. Staff: 3.1. Work load and work experience The questionnaire they received was designed by the researchers themselves. A copy can be requested through the contact details below. Additionally, staff filled out the Utrecht Burnout Scale (Utrechtse Burnout Schaal) (UBOS-C), a questionnaire for professions in which physical contact is present All patient and family outcomes will be measured at baseline (i.e. start of study), 6 months and one year. Staff outcomes will be measured at the beginning and end of the study. All questionnaires used were in the Dutch language.
Completion date	01/06/2010

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	All
Target sample size at registration	180
Key inclusion criteria	Care centres were selected based on the kind of wards existing contacts and willingness to participate. Traditional and Small-scale closed-environment wards were selected with a policy indicating that a patient can stay there till the end of their life. From those care centres participants were selected who were patients suffering from dementia, over the age of 70, of either sex. Also, information from family and direct care-givers of the participants were included in the study. For every participant a compliance form was filled out and returned by the family to the researchers
Key exclusion criteria	1. Patients did not fit the inclusion criteria 2. Patients did not finish the study. This could happen for example by a death or by moving to another institution.
Date of first enrolment	01/06/2007
Date of final enrolment	01/06/2010

Locations

Countries of recruitment

Belgium
Netherlands

Study participating centre

Care Centre De Kievitshorst

Tilburg
5042WN
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	caregivers' questionnaire results	01/06/2012		Yes	No
Results article	results	01/11/2012		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes