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

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

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

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?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

88

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

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

65 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
  • 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
No Intervention: Control
Control group with treatment as usual
Experimental: Robot-assisted activity
30 minutes group session with robot-assisted activity with the robot seal Paro twice a week for 12 weeks in groups of 4-6 participants
Other: Robot-assisted activity

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Norwegian version of The Brief Agitation Rating Scale
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Norwegian version of Cornell scale for depression
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
Change in Norwegian version of QUALID
Time Frame: 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
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
Change in behaviours, engagement and well-being measured by use of Dementia Care Mapping
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.
Second last or last week before the intervention starts, after 6 weeks of the intervention, and first or second week after end of intervention.
Change in physical activity measured by use of 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.
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
Time Frame: After two and ten weeks of the interventions
The video recorded will be analyzed with respect to social interaction and group dynamics
After two and ten weeks of the interventions
Change in use of ordinary and optional medication
Time Frame: Second last or last week before the intervention starts, first or second week after end of intervention and 3 months after end of intervention
Second last or last week before the intervention starts, first or second week after end of intervention and 3 months after end of intervention

Collaborators and Investigators

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

Sponsor

Norwegian University of Life Sciences

Collaborators

Vestfold University College

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

November 19, 2013

First Submitted That Met QC Criteria

November 27, 2013

First Posted (Estimate)

November 29, 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

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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