Animal-assisted Interventions in Health Promotion for Elderly With Dementia
Primary Purpose
Dementia
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Animal-assisted activity
Animal-assisted therapy
Sponsored by
About this trial
This is an interventional supportive care trial for Dementia
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
Sites / Locations
- Solgården Dagsenter
- Lommedalen dagsenter
- Vallerhjemmet dagsenter
- Pålsetunet dagsenter
- Fjerdingby dagsenter
- Glemmen dagsenter
- Tjølling dagsenter
- Husebyjordet dagsenter
- Åråsveien dagsenter
- Myraveien Dagsenter
- Skogbrynet dagsenter
- Dagsenter Nedre Eiker
- Nes Dagsenter
- Bjønnesåsen Dagsenter
- Bjørkås dagsenter
- Re Dagsenter
- Lunden dagsenter
- Sandetun dagsenter
- Sørvald dagsenter
- Eik dagsenter
- Nes dagsenter
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Animal-assisted activity
Animal-assisted therapy
Control
Arm Description
30 minutes group session with animal-assisted activity twice a week for 12 weeks in groups of 4-6 participants.
30 minutes group session with animal-assisted therapy twice a week for 12 weeks in groups of 4-6 participants
Control group with treatment as usual
Outcomes
Primary Outcome Measures
Change in Norwegian version of Berg balance test
Secondary Outcome Measures
Change in Norwegian version of Quality of Life in Late-Stage Dementia (QUALID)
Full Information
NCT ID
NCT02008630
First Posted
December 6, 2013
Last Updated
September 26, 2014
Sponsor
Norwegian University of Life Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02008630
Brief Title
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
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Norwegian University of Life Sciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
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:
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?
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
122 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Animal-assisted activity
Arm Type
Experimental
Arm Description
30 minutes group session with animal-assisted activity twice a week for 12 weeks in groups of 4-6 participants.
Arm Title
Animal-assisted therapy
Arm Type
Experimental
Arm Description
30 minutes group session with animal-assisted therapy twice a week for 12 weeks in groups of 4-6 participants
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control group with treatment as usual
Intervention Type
Other
Intervention Name(s)
Animal-assisted activity
Intervention Type
Other
Intervention Name(s)
Animal-assisted therapy
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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 Pre-specified Outcome Measures:
Title
Change in physical activity measured by Actigraphy
Description
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.
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
Title
Video recordings of two group session at each location
Description
The video recordings will be analyzed with respect to social interaction and group dynamics
Time Frame
After two and ten weeks of the intervention
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Camilla Ihlebæk, PhD
Organizational Affiliation
Norwegian University of Life Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Solgården Dagsenter
City
Asker
Country
Norway
Facility Name
Lommedalen dagsenter
City
Bærum
Country
Norway
Facility Name
Vallerhjemmet dagsenter
City
Bærum
Country
Norway
Facility Name
Pålsetunet dagsenter
City
Fet
Country
Norway
Facility Name
Fjerdingby dagsenter
City
Fjerdingby
Country
Norway
Facility Name
Glemmen dagsenter
City
Fredrikstad
Country
Norway
Facility Name
Tjølling dagsenter
City
Larvik
Country
Norway
Facility Name
Husebyjordet dagsenter
City
Lillestrøm
Country
Norway
Facility Name
Åråsveien dagsenter
City
Lillestrøm
Country
Norway
Facility Name
Myraveien Dagsenter
City
Moss
Country
Norway
Facility Name
Skogbrynet dagsenter
City
Moss
Country
Norway
Facility Name
Dagsenter Nedre Eiker
City
Nedre Eiker
Country
Norway
Facility Name
Nes Dagsenter
City
Nes
Country
Norway
Facility Name
Bjønnesåsen Dagsenter
City
Nøtterøy
Country
Norway
Facility Name
Bjørkås dagsenter
City
Oppegård
Country
Norway
Facility Name
Re Dagsenter
City
Re
Country
Norway
Facility Name
Lunden dagsenter
City
Sandefjord
Country
Norway
Facility Name
Sandetun dagsenter
City
Sande
Country
Norway
Facility Name
Sørvald dagsenter
City
Sørum
Country
Norway
Facility Name
Eik dagsenter
City
Tønsberg
Country
Norway
Facility Name
Nes dagsenter
City
Tønsberg
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
27155968
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.
Results Reference
derived
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Animal-assisted Interventions in Health Promotion for Elderly With Dementia
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