Plain English Summary
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
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
NL50623.096.14
Study information
Scientific title
Animal-assisted interventions in Dutch dementia care: effects on quality of life and neuropsychiatric symptoms
Acronym
Study hypothesis
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
Medical Ethics Committee Atrium-Orbis-Zuyd (Heerlen, The Netherlands), 10/11/2014, ref: NL50623096.14
Study design
Single-centre randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
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
Phase
Drug names
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 trial start date
01/09/2014
Overall trial end date
01/03/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. 24/7 nursing home client
2. Diagnosis of dementia
3. Consent by legal guardian
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
120
Participant 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
Recruitment start date
01/11/2014
Recruitment end date
01/01/2015
Locations
Countries of recruitment
Netherlands
Trial participating centre
De Zorgboog
Bakel
5760 AA
Netherlands
Sponsor information
Organisation
Open Universiteit Nederland
Sponsor details
Valkenburgerweg 177
Heerlen
6419 AT
Netherlands
Sponsor type
University/education
Website
Funders
Funder type
Hospital/treatment centre
Funder name
De Zorgboog Nursing Homes
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
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 statement
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.
Intention to publish date
01/03/2019
Participant level data
Not expected to be available
Basic results (scientific)
Publication list