Animal-assisted Interventions in Health Promotion for Elderly With Dementia

September 26, 2014 updated by: Camilla Ihlebæk, Norwegian University of Life Sciences

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

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?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

122

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Asker, Norway
        • Solgården Dagsenter
      • Bærum, Norway
        • Lommedalen dagsenter
      • Bærum, Norway
        • Vallerhjemmet dagsenter
      • Fet, Norway
        • Pålsetunet dagsenter
      • Fjerdingby, Norway
        • Fjerdingby dagsenter
      • Fredrikstad, Norway
        • Glemmen dagsenter
      • Larvik, Norway
        • Tjølling dagsenter
      • Lillestrøm, Norway
        • Husebyjordet dagsenter
      • Lillestrøm, Norway
        • Åråsveien dagsenter
      • Moss, Norway
        • Myraveien Dagsenter
      • Moss, Norway
        • Skogbrynet dagsenter
      • Nedre Eiker, Norway
        • Dagsenter Nedre Eiker
      • Nes, Norway
        • Nes dagsenter
      • Nøtterøy, Norway
        • Bjønnesåsen Dagsenter
      • Oppegård, Norway
        • Bjørkås dagsenter
      • Re, Norway
        • Re Dagsenter
      • Sande, Norway
        • Sandetun dagsenter
      • Sandefjord, Norway
        • Lunden dagsenter
      • Sørum, Norway
        • Sørvald dagsenter
      • Tønsberg, Norway
        • Eik dagsenter
      • Tønsberg, Norway
        • Nes dagsenter

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

63 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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
Time Frame
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Second last or last week before the intervention starts, after 6 weeks of the intervention, and first or second week after end of intervention
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
After two and ten weeks of the intervention
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norwegian University of Life Sciences

Investigators

  • Principal Investigator: Camilla Ihlebæk, PhD, Norwegian University of Life Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

December 6, 2013

First Submitted That Met QC Criteria

December 10, 2013

First Posted (Estimate)

December 11, 2013

Study Record Updates

Last Update Posted (Estimate)

September 29, 2014

Last Update Submitted That Met QC Criteria

September 26, 2014

Last Verified

September 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012/1144-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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