Condition category
Mental and Behavioural Disorders
Date applied
23/08/2017
Date assigned
18/09/2017
Last edited
12/09/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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

Contact information

Type

Public

Primary contact

Ms Lonneke Schuurmans

ORCID ID

Contact details

Postalnr: 5330
Postbus 16
Bakel
5760 AA
Netherlands

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 measures

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

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

http://www.ou.nl

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes