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The pros and cons of small-scale living for elderly people suffering from dementia in the Netherlands and Belgium
ISRCTN ISRCTN23772945
DOI 10.1186/ISRCTN23772945
ClinicalTrials.gov identifier
EudraCT number
Public title The pros and cons of small-scale living for elderly people suffering from dementia in the Netherlands and Belgium
Scientific title Perspectives on the results of small-scale living facilities in the Netherlands and Belgium
Acronym N/A
Serial number at source N/A
Study hypothesis 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?
Lay summary Not provided at time of registration
Ethics approval 1. Ethics committee of the University of Tilburg approved in April 2007
2. Ethics committee of De Wever approved in April 2007
Study design Multicentre cross-national longitudinal qualitative study
Countries of recruitment Belgium, Netherlands
Disease/condition/study domain Severe dementia
Participants - 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
Participants - 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.
Anticipated start date 01/06/2007
Anticipated end date 01/06/2010
Status of trial Completed
Patient information material Not available in web format, please use contact details below to request a patient information sheet
Target number of participants 180
Interventions 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.
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.
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.
Sources of funding University of Tilburg (Netherlands) - Department Tranzo
Trial website
Publications 1. 2012 caregivers' questionnaire results in http://www.ncbi.nlm.nih.gov/pubmed/22326947
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22882729
Contact name Ms  Ietje  de Rooij
  Address Care Centre De Kievitshorst
Beneluxlaan 101
  City/town Tilburg
  Zip/Postcode 5042WN
  Country Netherlands
Sponsor University of Tilburg (Netherlands) - Department Tranzo
  Address Faculty of Social and Behavioral Sciences
Po box 90153
  City/town Tilburg
  Zip/Postcode 5000 LE
  Country Netherlands
  Tel + 31 (0)13 466 2969
  Fax + 31 (0)13 466 3637
  Email tranzo@uvt.nl
  Sponsor website: http://www.tilburguniversity.nl/faculties/fsw/departments/tranzo/
Date applied 29/04/2010
Last edited 03/04/2013
Date ISRCTN assigned 12/05/2010
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