Effects of small scaled special care units for patients with dementia
| ISRCTN | ISRCTN11151241 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11151241 |
| Secondary identifying numbers | 009-2302 |
- Submission date
- 05/06/2017
- Registration date
- 21/06/2017
- Last edited
- 07/03/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
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
Contact information
Scientific
Dignis|Lentis
PO Box 128
9470AC
Zuidlaren
9470AC
Netherlands
 ORCID ID |
0000-0003-3969-572X |
|---|
Study information
| Study design | Longitudinal quasi-experimental field study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| 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 |
| 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(s) | The Ethical Committee of the Department of Psychology of the University of Groningen, 03/06/2009, ref: PPO-008-093 |
| 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 |
| Primary outcome measure | 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 study start date | 03/06/2009 |
| Overall study end date | 12/12/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 145 patients |
| Participant inclusion criteria | 1. Age 65 - 100 2. Diagnosis of dementia reported in the medical file |
| 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
Study participating centre
9470AC
Netherlands
Sponsor information
University/education
Department of Clinical Neuropsychology
van der Boechorstraat 1
Amsterdam
1081BT
Netherlands
| Phone | +31 (0)20 598 8888 |
|---|---|
| eja.scherder@vu.nl | |
| Website | www.vu.nl |
"ROR" |
https://ror.org/008xxew50 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 01/01/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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 plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Mr Jeroen Kok |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 16/02/2016 | Yes | No | |
| Results article | results | 05/07/2017 | Yes | No | |
| Results article | results | 27/02/2018 | Yes | No | |
| Results article | results | 01/04/2020 | 07/03/2019 | Yes | No |
Editorial Notes
07/03/2019: Publication reference added.
07/03/2018: Publication reference added.
19/10/2017: Publication reference added.
