Animal-assisted or Robot-assisted Interventions in Health Promotion for Elderly With Dementia
1 other identifier
interventional
88
1 country
15
Brief Summary
The overall research aim of this study is to investigate changes in measures related to the risk of falls among elderly with dementia participating in animal-assisted or robot-assisted interventions. In addition the study will investigate how knowledge transfer occurs among involved health personnel, and how knowledge is refined and transformed as practical competence. The design will be a prospective and cluster randomized multicenter trial, but mixed-methods will be used to target different outcomes. The study population will be elderly (age above 65) at nursing homes diagnosed with dementia, or having a cognitive deficit. The intervention will consist of 30 minutes sessions with animal-assisted activity or robot-assisted activity two times a week for 12 weeks in groups of 4-6 participants. Control groups will receive treatment as usual. Research questions:
- 1.Is there an effect in use of ordinary and optional medication among elderly persons with dementia at nursing homes participating in animal-assisted or robot-assisted interventions compared to a control group?
- 2.Is there an effect on agitation, restlessness and depression among elderly persons with dementia at nursing homes participating in animal-assisted or robot-assisted interventions compared to a control group?
- 3.Is there an effect on social interaction, activeness and wellbeing among elderly persons with dementia at nursing homes participating in animal-assisted or robot-assisted interventions compared to a control group?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2013
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
November 19, 2013
CompletedFirst Posted
Study publicly available on registry
November 29, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedSeptember 29, 2014
September 1, 2014
1.3 years
November 19, 2013
September 26, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Norwegian version of The Brief Agitation Rating Scale
Second last or last week before the intervention starts, after 4 and 8 weeks of the intervention, and first or second week after end of intervention. A follow-up measure 3 months after end of the intervention
Other Outcomes (6)
Change in Norwegian version of Cornell scale for depression
Second last or last week before the intervention starts, after 4 and 8 weeks of the intervention, and first or second week after end of intervention. A follow-up measure 3 months after end of the intervention
Change in Norwegian version of QUALID
Second last og last week before the intervention starts, after 6 weeks of the intervention, and first or second week after end of intervention. A follow-up measure 3 months after end of the intervention
Change in behaviours, engagement and well-being measured by use of Dementia Care Mapping
Second last or last week before the intervention starts, after 6 weeks of the intervention, and first or second week after end of intervention.
- +3 more other outcomes
Study Arms (3)
Animal-assisted activity
EXPERIMENTAL30 minutes group session with animal-assisted activity twice a week for 12 weeks in groups of 4-6 participants.
Robot-assisted activity
EXPERIMENTAL30 minutes group session with robot-assisted activity with the robot seal Paro twice a week for 12 weeks in groups of 4-6 participants
Control
NO INTERVENTIONControl group with treatment as usual
Interventions
Eligibility Criteria
You may qualify if:
- \- Diagnosis of dementia or having a cognitive deficit measured as a score less than 25 on Mini-Mental State Examination.
You may not qualify if:
- Fear of dogs
- Dog allergy
- Need of wheel chair
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Norwegian University of Life Scienceslead
- Vestfold University Collegecollaborator
Study Sites (15)
Pålsetunet bo- og servicesenter
Fet, Norway
Solliheimen Sykehjem
Fredrikstad, Norway
Solheimen senter
Halden, Norway
Frida Sykehjem
Larvik, Norway
Lørenskog Sykehjem, avd. Losbyveien
Lørenskog, Norway
Løreskog sykhjem, avd Krydderhagen
Lørenskog, Norway
Orkerød Sykehjem
Moss, Norway
Ryggeheimen
Moss, Norway
Gipø Sykehjem
Nøtterøy, Norway
Greverud Sykehjem
Oppegård, Norway
Høyås Sykehjem
Oppegård, Norway
Sandetun Sykehjem
Sande, Norway
Kamfjordhjemmet
Sandefjord, Norway
Sørvald bo- og behandlingssenter
Sørum, Norway
Tjøme Sykehjem
Tjøme, Norway
Related Publications (1)
Joranson N, Pedersen I, Rokstad AM, Ihlebaek C. Change in quality of life in older people with dementia participating in Paro-activity: a cluster-randomized controlled trial. J Adv Nurs. 2016 Dec;72(12):3020-3033. doi: 10.1111/jan.13076. Epub 2016 Aug 16.
PMID: 27434512DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Camilla Ihlebæk, PhD
Norwegian University of Life Sciences
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 19, 2013
First Posted
November 29, 2013
Study Start
January 1, 2013
Primary Completion
May 1, 2014
Study Completion
August 1, 2014
Last Updated
September 29, 2014
Record last verified: 2014-09