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Completed

NCT Number: NCT02008630

Animal-assisted Interventions in Health Promotion for Elderly With Dementia

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?

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Key information

Conditions

Dementia Brain Diseases Central Nervous System Diseases Mental Disorders Nervous System Diseases Neurocognitive Disorders

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Solgården Dagsenter, Asker, Norway

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

animal-assisted activity

Other

Animal-assisted therapy

Other

Primary outcomes

  1. Change in Norwegian version of Berg balance test

    Time frame: 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

  1. Change in Norwegian version of Quality of Life in Late-Stage Dementia (QUALID)

    Time frame: 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

  1. Change in physical activity measured by Actigraphy

    Time frame: 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 device worn by the participants for one week at each time point of measure, night and day, measuring physical movement. Will be used to calculate physical activity during day time and sleep efficacy during the night.

  2. Video recordings of two group session at each location

    Time frame: After two and ten weeks of the intervention

    The video recordings will be analyzed with respect to social interaction and group dynamics

  3. Change in optional and ordinary medication

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Norwegian University of Life Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 11, 2013
Registry last updated
Sep 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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