Condition category
Mental and Behavioural Disorders
Date applied
05/06/2017
Date assigned
21/06/2017
Last edited
21/06/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Dementia is a broad category of brain diseases that cause a long-term gradual decrease in the ability to think and remember that affects a person's daily functioning. Evidence shows that treatment in a small scaled home-like Special Care Unit (SCU) can have positive effects on the behavioral and psychological symptoms of patients with dementia. Aspects of cognition (thinking), rest/activity, mood and medication use are scarcely investigated. The aim of this study is to gain more insight into the effects of living in a small-scale home-like SCU compared to a regular traditional SCU for residents with dementia.

Who can participate?
Patients aged 65 – 100 with dementia living in two regular SCUs

What does the study involve?
Participants living in one of the SCUs move to a small scaled home-like SCU (intervention group) and the participants in the other SCU stay at their regular SCU (control group). The participants’ cognitive functions, rest/activity, mood and medication use are assessed with tests, observations, questionnaires and information from medical files. All the data are collected 3 months before, 3 months after and 6 months after the relocation of the intervention group.

What are the possible benefits and risks of participating?
No benefits or risks are expected for the participants.

Where is the study run from?
Dignis|Lentis - Nursing home 'De Enk' (Netherlands)

When is the study starting and how long is it expected to run for?
June 2009 to December 2012

Who is funding the study?
Lentis (Netherlands)

Who is the main contact?
Mr Jeroen Kok

Trial website

Contact information

Type

Scientific

Primary contact

Mr Jeroen Kok

ORCID ID

http://orcid.org/0000-0003-3969-572X

Contact details

Dignis|Lentis
PO Box 128
9470AC
Zuidlaren
9470AC
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

009-2302

Study information

Scientific title

A longitudinal controlled trial comparing patients with dementia living in a regular special care unit with patients with dementia living in a small scaled home-like special care unit

Acronym

Study hypothesis

The aim of the study is to investigate the possible positive effects on patients with dementia of living in a small scaled homelike special care unit (SCU) on cognition, rest/activity, mood, quality of life and medication use compared to patients with dementia living in a regular special care unit.

Ethics approval

The Ethical Committee of the Department of Psychology of the University of Groningen, 03/06/2009, ref: PPO-008-093

Study design

Longitudinal quasi-experimental field study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Dementia

Intervention

The patients were living in two different nursing homes before the study started. Patients of the intervention group were relocated from their regular SCU to a small-scale home-like SCU due to organizational reasons (the building no longer met the requirements of the current healthcare standards). The control group stayed in their regular SCU during the study. All measurements were conducted at baseline (3 months before intervention), follow up 1 (3 months after intervention) and follow up 2 (6 months after intervention).

Intervention type

Other

Phase

Drug names

Primary outcome measures

All measurements conducted at baseline (3 months before intervention), follow up 1 (3 months after intervention) and follow up 2 (6 months after intervention).

1. Cognition:
1.1. Cognitive status, assessed using the Dutch version of the Standardized Mini-Mental State Examination
1.2. Verbal memory, assessed using the Eight Word Verbal Memory Test of the Amsterdam Dementia Screening Test (ADS)
1.3. Visual memory, recognition of pictures and recognition of faces, assessed using two subtests of the Rivermead Behavioural Memory Test (RBMT)
1.4. Language functioning, assessed using the shortened Boston Naming Test-15 (BNT)
1.5. Different aspects of praxis, assessed using the diagnostic test for apraxia of van Heugten
1.6. Executive control, measured using the Trail Making Test A and B, The Category Fluency Task from the Groningen Intelligence Test (GIT) and a Clock Drawing test
1.7. Figure recognition, assessed using a subtask of the GIT, Incomplete Drawings
1.8. Aspects of cognition, observed by nursing personnel with a behavioural observation scale for intramural psychogeriatry (GIP)
1.9. Cognitive decline, measured using the Information Questionnaire on Cognitive Decline in the Elderly

2. Rest/activity:
2.1. Objective rest-activity variables, measured with an Actiwatch (Cambridge Neurotechnology Ltd, Cambridge, UK)
2.2. Intersubjective activity level, assessed by using two scales of a behavioral observation scale for intramural psychogeriatry (GIP)

3. Quality of life:
3.1. Quality of life, assessed using the QUALIDEM
3.2. Relevant neuropsychiatric symptoms of quality of life, collected with subscales of the GIP

4. Mood, assessed with the Dutch version of the Geriatric Depression Scale-15 (GDS-15)

5. Medication use, assessed using tnformation from medical files

Secondary outcome measures

No secondary outcome measures

Overall trial start date

03/06/2009

Overall trial end date

12/12/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age 65 - 100
2. Diagnosis of dementia reported in the medical file

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

145 patients

Participant exclusion criteria

No dementia reported in the medical file

Recruitment start date

01/01/2009

Recruitment end date

01/06/2009

Locations

Countries of recruitment

Netherlands

Trial participating centre

Dignis|Lentis - Nursing home 'De Enk'
Zuidlaren
9470AC
Netherlands

Sponsor information

Organisation

VU University Amsterdam

Sponsor details

Department of Clinical Neuropsychology
van der Boechorstraat 1
Amsterdam
1081BT
Netherlands
+31 (0)20 598 8888
eja.scherder@vu.nl

Sponsor type

University/education

Website

www.vu.nl

Funders

Funder type

Hospital/treatment centre

Funder name

Lentis

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

1. Rest-activity Rhythms in Small Scale Homelike Care and Traditional Care for Residents with Dementia: July 2017
2. Quality of life and mood in small scaled homelike nursing homes: a 1-year follow up study: September 2017
3. Medication use in small scaled homelike nursing homes: a 1-year follow up study: January 2018

IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Mr Jeroen Kok

Intention to publish date

01/01/2018

Participant level data

Available on request

Results - basic reporting

Publication summary

2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/26883324

Publication citations

Additional files

Editorial Notes