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

NCT ID: NCT01998490

Last Updated: 2014-09-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2014-08-31

Brief Summary

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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?

Detailed Description

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Conditions

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Dementia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Animal-assisted activity

30 minutes group session with animal-assisted activity twice a week for 12 weeks in groups of 4-6 participants.

Group Type EXPERIMENTAL

Animal-assisted activity

Intervention Type OTHER

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

Group Type EXPERIMENTAL

Robot-assisted activity

Intervention Type OTHER

Control

Control group with treatment as usual

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Animal-assisted activity

Intervention Type OTHER

Robot-assisted activity

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vestfold University College

OTHER

Sponsor Role collaborator

Norwegian University of Life Sciences

OTHER

Sponsor Role lead

Responsible Party

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Camilla Ihlebæk

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Camilla Ihlebæk, PhD

Role: PRINCIPAL_INVESTIGATOR

Norwegian University of Life Sciences

Locations

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Pålsetunet bo- og servicesenter

Fet, , Norway

Site Status

Solliheimen Sykehjem

Fredrikstad, , Norway

Site Status

Solheimen senter

Halden, , Norway

Site Status

Frida Sykehjem

Larvik, , Norway

Site Status

Lørenskog Sykehjem, avd. Losbyveien

Lørenskog, , Norway

Site Status

Løreskog sykhjem, avd Krydderhagen

Lørenskog, , Norway

Site Status

Orkerød Sykehjem

Moss, , Norway

Site Status

Ryggeheimen

Moss, , Norway

Site Status

Gipø Sykehjem

Nøtterøy, , Norway

Site Status

Greverud Sykehjem

Oppegård, , Norway

Site Status

Høyås Sykehjem

Oppegård, , Norway

Site Status

Sandetun Sykehjem

Sande, , Norway

Site Status

Kamfjordhjemmet

Sandefjord, , Norway

Site Status

Sørvald bo- og behandlingssenter

Sørum, , Norway

Site Status

Tjøme Sykehjem

Tjøme, , Norway

Site Status

Countries

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Norway

References

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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.

Reference Type DERIVED
PMID: 27434512 (View on PubMed)

Other Identifiers

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2012/1144

Identifier Type: -

Identifier Source: org_study_id

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