A study into the effects of activities with animals on the well-being of Dutch nursing home patients with dementia
| ISRCTN | ISRCTN93568533 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN93568533 |
| Secondary identifying numbers | NL50623.096.14 |
- Submission date
- 23/08/2017
- Registration date
- 18/09/2017
- Last edited
- 13/04/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
The aim of this study is to explore the effect of dog or robot assisted activities on nursing home clients with dementia. The researchers are specifically interested in what happens during the activities. Do participating clients display less problematic behavior? Do they interact more with either the dog/robot or each other?
Who can participate?
Patients with dementia living in De Zorgboog, a large Dutch nursing home
What does the study involve?
Participants are randomly allocated to attend videotaped weekly group activity sessions with either a dog (and handler), a robot (FurReal Friend, with handler), or a handler only, over a period of 8 weeks. Quality of life, mood and behaviour are assessed during this time period and a 4 week follow-up using questionnaires.
What are the possible benefits and risks of participating?
Participating in this study will provide nursing home clients with an additional weekly activity for 8 weeks providing social contact and the possibility to interact with either a dog or an animal-robot. Interacting with dogs could potentially increase risk of injury, disease or inconvenience due to allergies. These risks have been minimised by using only certified animal-assisted intervention dogs that have been vaccinated and checked by a veterinarian. Furthermore, people with known dog allergies are excluded from participating. The study is also covered by a specific research insurance policy during the course of the intervention period.
Where is the study run from?
De Zorgboog Nursing Homes (Netherlands)
When is the study starting and how long is it expected to run for?
September 2014 to March 2019
Who is funding the study?
De Zorgboog Nursing Homes (Netherlands)
Who is the main contact?
Ms Lonneke Schuurmans
Contact information
Public
Postalnr: 5330
Postbus 16
Bakel
5760 AA
Netherlands
Study information
| Study design | Single-centre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Animal-assisted interventions in Dutch dementia care: effects on quality of life and neuropsychiatric symptoms |
| Study objectives | Quality of life and neuropsychiatric symptoms of nursing home clients with dementia are positively influenced by group sessions offering either dog-assisted activities or robot-assisted activities, when compared with a control group. |
| Ethics approval(s) | Medical Ethics Committee Atrium-Orbis-Zuyd (Heerlen, The Netherlands), 10/11/2014, ref: NL50623096.14 |
| Health condition(s) or problem(s) studied | Dementia |
| Intervention | Nursing home clients are randomised via computer generated random numbers to three groups with protocolled activities: Group 1: dog assisted activity group sessions with handler Group 2: robot assisted activity group sessions with handler (FurReal Friend robot) Group 3: (control): group sessions with a visiting student Nursing home clients attend videotaped once a week group sessions with a total duration of 8 weeks and a 4 week follow-up. Quality of life, mood and behavior of participating clients are measured using questionnaires. |
| Intervention type | Other |
| Primary outcome measure | 1. Social interaction during sessions 2. Neuropsychiatric symptoms during sessions Each client will participate in one intervention session a week. All sessions will be videotaped for the entire duration of the study (8 weeks). Videos will be analysed after the intervention period using video-coding to calculate the amount of social interactions and neuropsychiatric symptoms displayed during the sessions. |
| Secondary outcome measures | Questionnaires will be used to measure several secondary outcomes at all or a subset of the following timepoints: baseline (t0), after 4 weeks (t1, halfway), after 8 weeks (t2, at the end of the intervention period), after 12 weeks (t3, 4 weeks post intervention follow-up): 1. Quality of life, measured using Qualidem at t0, t1, t2, t3 2. Depression, measured using Cornell Scale for Depression in Dementia (CSDD) at t0, t1, t2, t3 3. Neuropsychiatric symptoms, measured using Neuropsychiatric Inventory Questionnaire (NPI-Q) at t0, t1, t2, t3 4. Agitation, measured using Cohen-Mansfield Agitation Inventory (CMAI) at t0, t1, t2, t3 5. Medication usage, measured using medical records at t0, t2 6. Intercurrent diseases, measured using medical records at t0, t2 7. Dementia stage, measured using Clinical Dementia Rating (CDR) at t0, t2 8. Functional state, measured using Interview for Deteriorating in Daily living activities in Dementia (IDDD) at t0, t2 9. Dementia, assessed using Gedragsobservatie Intramurale Psychogeriatrie (GIP, general dementia assessment tool, Dutch) at t0, t2 |
| Overall study start date | 01/09/2014 |
| Completion date | 01/03/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 120 |
| Key inclusion criteria | 1. 24/7 nursing home client 2. Diagnosis of dementia 3. Consent by legal guardian |
| Key exclusion criteria | 1. Clients resisting participation, either verbal or non-verbal 2. Clients with a trauma related to animals in life history 3. Clients with a dog allergy 4. Clients with severe aggression that might endanger other clients or the participating dogs |
| Date of first enrolment | 01/11/2014 |
| Date of final enrolment | 01/01/2015 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
5760 AA
Netherlands
Sponsor information
University/education
Valkenburgerweg 177
Heerlen
6419 AT
Netherlands
| Website | http://www.ou.nl |
|---|---|
"ROR" |
https://ror.org/018dfmf50 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 01/03/2019 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Results will be published as part of a PhD project in several peer reviewed journals. Publication should ensue no later than 01/03/2019. The trialists intend to publish the video-coding sheet and study protocol as an online supplement to the publications in a peer-reviewed journal, if the journal in question offers that type of online supplement. |
| IPD sharing plan | Due to the sensitive nature of the video-material the trialists are obliged under restrictions set by the medical ethics committee to destroy the video-material after completion of the PhD project. The medical records and questionnaires of participants will be kept in the medical archive of the nursing home for 15 years. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 27/09/2019 | 13/04/2021 | Yes | No |
Editorial Notes
13/04/2021: Publication reference added.
