Condition category
Mental and Behavioural Disorders
Date applied
29/04/2010
Date assigned
12/05/2010
Last edited
03/04/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Ietje de Rooij

ORCID ID

Contact details

Care Centre De Kievitshorst
Beneluxlaan 101
Tilburg
5042WN
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Perspectives on the results of small-scale living facilities in the Netherlands and Belgium

Acronym

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?

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

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 measures

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.

Overall trial start date

01/06/2007

Overall trial end date

01/06/2010

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

180

Participant 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.

Recruitment start date

01/06/2007

Recruitment end date

01/06/2010

Locations

Countries of recruitment

Belgium, Netherlands

Trial participating centre

Care Centre De Kievitshorst
Tilburg
5042WN
Netherlands

Sponsor information

Organisation

University of Tilburg (Netherlands) - Department Tranzo

Sponsor details

Faculty of Social and Behavioral Sciences
Po box 90153
Tilburg
5000 LE
Netherlands
+ 31 (0)13 466 2969
tranzo@uvt.nl

Sponsor type

University/education

Website

http://www.tilburguniversity.nl/faculties/fsw/departments/tranzo/

Funders

Funder type

University/education

Funder name

University of Tilburg (Netherlands) - Department Tranzo

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

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

Publication citations

  1. Results

    de Rooij AH, Luijkx KG, Spruytte N, Emmerink PM, Schols JM, Declercq AG, Family caregiver perspectives on social relations of elderly residents with dementia in small-scale versus traditional long-term care settings in the Netherlands and Belgium., J Clin Nurs, 2012, 21, 21-22, 3106-3116, doi: 10.1111/j.1365-2702.2012.04110.x.

  2. de Rooij AH, Luijkx KG, Declercq AG, Emmerink PM, Schols JM, Professional caregivers' mental health problems and burnout in small-scale and traditional long term care settings for elderly people with dementia in the Netherlands and Belgium., J Am Med Dir Assoc, 2012, 13, 5, 486.e7-11, doi: 10.1016/j.jamda.2012.01.001.

Additional files

Editorial Notes