Clinical trial NCT02008630: Animal-assisted Interventions in Health Promotion for Elderly With Dementia
Official title: Animal-assisted Interventions in Health Promotion for Elderly With Dementia; Impact on Factors Related to Risk of Falls
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Lead sponsor: Norwegian University of Life Sciences
Sponsor class: OTHER
First posted: 2013-12-11
Enrollment: 122
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 interventions. Also relatives' experience of own and the elderly's situation during and after the intervention will be examined. 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 day care centers diagnosed with dementia, or having a cognitive deficit. The intervention will consist of 30 minutes sessions with animal-assisted activity or animal-assisted therapy 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 day care centers participating in animal-assisted interventions compared to a control group?
2. Is there an effect on social interaction, quality of life, activeness and wellbeing among elderly persons with dementia at day care centers participating in animal-assisted interventions compared to a control group?
3. Is there an effect on balance among elderly persons with dementia at day care centers participating in animal-assisted therapy compared to animal-assisted activity or a control group?
4. Do relatives of elderly persons with dementia at day care centers experience a change in their own and the elderly's situation after the intervention compared with before the intervention started?


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 or need of wheel chair

Primary outcomes:
measure: Change in Norwegian version of Berg balance test
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:
measure: Change in Norwegian version of Quality of Life in Late-Stage Dementia (QUALID)
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. A follow-up measure 3 months after end of the intervention
Other outcomes:
measure: Change in physical activity measured by 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 of two group session at each location
timeFrame: After two and ten weeks of the intervention
measure: Change in optional and ordinary medication
timeFrame: Second last or last week before the intervention starts, first or second week after the end of intervention. A follow-up measure 3 months after end of the intervention
Locations:
city: Asker
country: Norway
facility: Solgården Dagsenter
city: Bærum
country: Norway
facility: Lommedalen dagsenter
city: Bærum
country: Norway
facility: Vallerhjemmet dagsenter
city: Fet
country: Norway
facility: Pålsetunet dagsenter
city: Fjerdingby
country: Norway
facility: Fjerdingby dagsenter
city: Fredrikstad
country: Norway
facility: Glemmen dagsenter
city: Larvik
country: Norway
facility: Tjølling dagsenter
city: Lillestrøm
country: Norway
facility: Husebyjordet dagsenter
city: Lillestrøm
country: Norway
facility: Åråsveien dagsenter
city: Moss
country: Norway
facility: Myraveien Dagsenter
city: Moss
country: Norway
facility: Skogbrynet dagsenter
city: Nedre Eiker
country: Norway
facility: Dagsenter Nedre Eiker
city: Nes
country: Norway
facility: Nes Dagsenter
city: Nøtterøy
country: Norway
facility: Bjønnesåsen Dagsenter
city: Oppegård
country: Norway
facility: Bjørkås dagsenter
city: Re
country: Norway
facility: Re Dagsenter
city: Sandefjord
country: Norway
facility: Lunden dagsenter
city: Sande
country: Norway
facility: Sandetun dagsenter
city: Sørum
country: Norway
facility: Sørvald dagsenter
city: Tønsberg
country: Norway
facility: Eik dagsenter
city: Tønsberg
country: Norway
facility: Nes dagsenter
Study officials:
affiliation: Norwegian University of Life Sciences
name: Camilla Ihlebæk, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Olsen C, Pedersen I, Bergland A, Enders-Slegers MJ, Ihlebaek C. Effect of animal-assisted activity on balance and quality of life in home-dwelling persons with dementia. Geriatr Nurs. 2016 Jul-Aug;37(4):284-91. doi: 10.1016/j.gerinurse.2016.04.002. Epub 2016 May 4.