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Animal-assisted or Robot-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
Robot-assisted activity
Sponsored by
Norwegian University of Life Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Dementia

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Pålsetunet bo- og servicesenter
  • Solliheimen Sykehjem
  • Solheimen senter
  • Frida Sykehjem
  • Lørenskog Sykehjem, avd. Losbyveien
  • Løreskog sykhjem, avd Krydderhagen
  • Orkerød Sykehjem
  • Ryggeheimen
  • Gipø Sykehjem
  • Greverud Sykehjem
  • Høyås Sykehjem
  • Kamfjordhjemmet
  • Sandetun Sykehjem
  • Sørvald bo- og behandlingssenter
  • Tjøme Sykehjem

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Animal-assisted activity

Robot-assisted activity

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 robot-assisted activity with the robot seal Paro 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 The Brief Agitation Rating Scale

Secondary Outcome Measures

Full Information

First Posted
November 19, 2013
Last Updated
September 26, 2014
Sponsor
Norwegian University of Life Sciences
Collaborators
Vestfold University College
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1. Study Identification

Unique Protocol Identification Number
NCT01998490
Brief Title
Animal-assisted or Robot-assisted Interventions in Health Promotion for Elderly With Dementia
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
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
Collaborators
Vestfold University College

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 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: 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? 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? 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?

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
88 (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
Robot-assisted activity
Arm Type
Experimental
Arm Description
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
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)
Robot-assisted activity
Primary Outcome Measure Information:
Title
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
Other Pre-specified Outcome Measures:
Title
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
Title
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
Title
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.
Title
Change in physical activity measured by use of Actigraphy
Description
A device worn by the participants for one week at each time point of measure, night and day, measuring physical movement.
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
Description
The video recorded will be analyzed with respect to social interaction and group dynamics
Time Frame
After two and ten weeks of the interventions
Title
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

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
27434512
Citation
Joranson N, Pedersen I, Rokstad AM, Ihlebaek C. Change in quality of life in older people with dementia participating in Paro-activity: a cluster-randomized controlled trial. J Adv Nurs. 2016 Dec;72(12):3020-3033. doi: 10.1111/jan.13076. Epub 2016 Aug 16. Erratum In: J Adv Nurs. 2017 Jun;73(6):1531.
Results Reference
derived

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

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