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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
88

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Norwegian University of Life Sciences

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Vestfold University College

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 19, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 27, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 29, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 29, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 26, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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