Animal-assisted Interventions in Health Promotion for Elderly With Dementia

Study Overview
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Brief Summary
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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: 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? 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? 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? 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?

Official Title
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Animal-assisted Interventions in Health Promotion for Elderly With Dementia; Impact on Factors Related to Risk of Falls

Conditions
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Dementia

Intervention / Treatment
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* Other: Animal-assisted activity
* Other: Animal-assisted therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Animal-assisted activity<br>30 minutes group session with animal-assisted activity twice a week for 12 weeks in groups of 4-6 participants. | Other: Animal-assisted activity<br> <br> |
| Experimental: Animal-assisted therapy<br>30 minutes group session with animal-assisted therapy twice a week for 12 weeks in groups of 4-6 participants | Other: Animal-assisted therapy<br> <br> |
| No Intervention: Control<br>Control group with treatment as usual | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Norwegian version of Berg balance test |  | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Norwegian version of Quality of Life in Late-Stage Dementia (QUALID) |  | 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 |