Animal-assisted Interventions in Health Promotion for Elderly With Dementia

Dementia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02008630
• Other study ID #: 2012/1144-1
• Status: Completed
• Phase: N/A
• First received: December 6, 2013
• Last updated: September 26, 2014
• Start date: January 2013
• Est. completion date: August 2014

Study information

• Verified date: September 2014
• Source: Norwegian University of Life Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:The Regional Comittees for Medical and Health Research Ethics in Norway
• Study type: Interventional

Clinical Trial 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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: August 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Dementia

Intervention

Other:
• Animal-assisted activity

• Animal-assisted therapy

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Norwegian University of Life Sciences

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in physical activity measured by Actigraphy	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	No
Other	Video recordings of two group session at each location	The video recordings will be analyzed with respect to social interaction and group dynamics	After two and ten weeks of the intervention	No
Other	Change in optional and ordinary medication		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	No
Primary	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	No
Secondary	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	No