Clinical trial NCT01998490: Animal-assisted or Robot-assisted Interventions in Health Promotion for Elderly With Dementia
Official title: Animal-assisted or Robot-assisted Interventions in Health Promotion for Elderly With Dementia: Impact on Factors Related to the Risk of Falls, on Evidence Based Practice and on the Relatives' Burden
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Lead sponsor: Norwegian University of Life Sciences
Sponsor class: OTHER
Collaborators: name: Vestfold University College
First posted: 2013-11-29
Enrollment: 88
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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?


Eligibility criteria: Inclusion Criteria:

- Diagnosis of dementia or having a cognitive deficit measured as a score less than 25 on Mini-Mental State Examination.

Exclusion Criteria:

* Fear of dogs
* Dog allergy
* Need of wheel chair

Primary outcomes:
measure: Change in Norwegian version of The Brief Agitation Rating Scale
timeFrame: 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
Secondary outcomes:
Other outcomes:
measure: Change in Norwegian version of Cornell scale for depression
timeFrame: 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
measure: Change in Norwegian version of QUALID
timeFrame: 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
measure: Change in behaviours, engagement and well-being measured by use of Dementia Care Mapping
timeFrame: Second last or last week before the intervention starts, after 6 weeks of the intervention, and first or second week after end of intervention.
measure: Change in physical activity measured by use of Actigraphy
timeFrame: Second last or last week before the intervention starts, after 6 weeks of the intervention, and first or second week after end of intervention
measure: Video recordings
timeFrame: After two and ten weeks of the interventions
measure: Change in use of ordinary and optional medication
timeFrame: Second last or last week before the intervention starts, first or second week after end of intervention and 3 months after end of intervention
Locations:
city: Fet
country: Norway
facility: Pålsetunet bo- og servicesenter
city: Fredrikstad
country: Norway
facility: Solliheimen Sykehjem
city: Halden
country: Norway
facility: Solheimen senter
city: Larvik
country: Norway
facility: Frida Sykehjem
city: Lørenskog
country: Norway
facility: Lørenskog Sykehjem, avd. Losbyveien
city: Lørenskog
country: Norway
facility: Løreskog sykhjem, avd Krydderhagen
city: Moss
country: Norway
facility: Orkerød Sykehjem
city: Moss
country: Norway
facility: Ryggeheimen
city: Nøtterøy
country: Norway
facility: Gipø Sykehjem
city: Oppegård
country: Norway
facility: Greverud Sykehjem
city: Oppegård
country: Norway
facility: Høyås Sykehjem
city: Sandefjord
country: Norway
facility: Kamfjordhjemmet
city: Sande
country: Norway
facility: Sandetun Sykehjem
city: Sørum
country: Norway
facility: Sørvald bo- og behandlingssenter
city: Tjøme
country: Norway
facility: Tjøme Sykehjem
Study officials:
affiliation: Norwegian University of Life Sciences
name: Camilla Ihlebæk, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.