Animal-assisted or Robot-assisted Interventions in Health Promotion for Elderly With Dementia

Dementia Clinical Trial

Official title:

Animal-assisted or Robot-assisted Interventions in Health Promotion for Elderly With Dementia: Impact on Factors Related to the Risk of Falls, on Evidence Based Practice and on the Relatives' Burden

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01998490
• Other study ID #: 2012/1144
• Status: Completed
• Phase: N/A
• First received: November 19, 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 or robot-assisted interventions. In addition the study will investigate how knowledge transfer occurs among involved health personnel, and how knowledge is refined and transformed as practical competence. 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 nursing homes diagnosed with dementia, or having a cognitive deficit. The intervention will consist of 30 minutes sessions with animal-assisted activity or robot-assisted activity 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 nursing homes participating in animal-assisted or robot-assisted interventions compared to a control group?

2. Is there an effect on agitation, restlessness and depression among elderly persons with dementia at nursing homes participating in animal-assisted or robot-assisted interventions compared to a control group?

3. Is there an effect on social interaction, activeness and wellbeing among elderly persons with dementia at nursing homes participating in animal-assisted or robot-assisted interventions compared to a control group?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• 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

• 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

• Robot-assisted activity

Locations

Country	Name	City	State
Norway	Pålsetunet bo- og servicesenter	Fet
Norway	Solliheimen Sykehjem	Fredrikstad
Norway	Solheimen senter	Halden
Norway	Frida Sykehjem	Larvik
Norway	Lørenskog Sykehjem, avd. Losbyveien	Lørenskog
Norway	Løreskog sykhjem, avd Krydderhagen	Lørenskog
Norway	Orkerød Sykehjem	Moss
Norway	Ryggeheimen	Moss
Norway	Gipø Sykehjem	Nøtterøy
Norway	Greverud Sykehjem	Oppegård
Norway	Høyås Sykehjem	Oppegård
Norway	Sandetun Sykehjem	Sande
Norway	Kamfjordhjemmet	Sandefjord
Norway	Sørvald bo- og behandlingssenter	Sørum
Norway	Tjøme Sykehjem	Tjøme

Sponsors (2)

Lead Sponsor	Collaborator
Norwegian University of Life Sciences	Vestfold University College

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Norwegian version of Cornell scale for depression		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
Other	Change in Norwegian version of QUALID		Second last og 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
Other	Change in behaviours, engagement and well-being measured by use of Dementia Care Mapping		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	Change in physical activity measured by use of Actigraphy	A device worn by the participants for one week at each time point of measure, night and day, measuring physical movement.	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	The video recorded will be analyzed with respect to social interaction and group dynamics	After two and ten weeks of the interventions	No
Other	Change in use of ordinary and optional medication		Second last or last week before the intervention starts, first or second week after end of intervention and 3 months after end of intervention	No
Primary	Change in Norwegian version of The Brief Agitation Rating Scale		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