DementiaNCT01998490
Animal-assisted or Robot-assisted Interventions in Health Promotion for Elderly With Dementia
A study testing Animal-assisted activity and Robot-assisted activity in people with Dementia, run by Norwegian University of Life Sciences at 15 sites in Norway.
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dementia
- What is being tested?
- Animal-assisted activity and Robot-assisted activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 15 sitesNorway
- Study dates
- Jan 2013to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Diagnosis of dementia or having a cognitive deficit measured as a score less than 25 on Mini-Mental State Examination.
Who cannot join
- Fear of dogs
- Dog allergy
- Need of wheel chair
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Norway15 sites
Pålsetunet bo- og servicesenter
Fet
Solliheimen Sykehjem
Fredrikstad
Solheimen senter
Halden
Frida Sykehjem
Larvik
Lørenskog Sykehjem, avd. Losbyveien
Lørenskog
Løreskog sykhjem, avd Krydderhagen
Lørenskog
Orkerød Sykehjem
Moss
Ryggeheimen
Moss
Gipø Sykehjem
Nøtterøy
Greverud Sykehjem
Oppegård
Høyås Sykehjem
Oppegård
Sandetun Sykehjem
Sande
Kamfjordhjemmet
Sandefjord
Sørvald bo- og behandlingssenter
Sørum
Tjøme Sykehjem
Tjøme
About this study
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
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?
- Conditions
- Dementia
- Being tested
- Animal-assisted activity, Robot-assisted activity
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Animal-assisted activityOther
Robot-assisted activityOther
| Study group | Role | What they receive |
|---|---|---|
| Animal-assisted activity | Experimental | 30 minutes group session with animal-assisted activity twice a week for 12 weeks in groups of 4-6 participants. Receives: Other: Animal-assisted activity |
| Robot-assisted activity | Experimental | 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 Receives: Other: Robot-assisted activity |
| Control | No intervention | Control group with treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Norwegian version of The Brief Agitation Rating Scale
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2013 (estimated)
- Study startJan 2013
- Primary completionMay 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Life Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Vestfold University College
- Responsible party
- Principal investigator, Camilla Ihlebæk, Norwegian University of Life Sciences
- Investigators
- Camilla Ihlebæk, PhD, Principal investigator, Norwegian University of Life Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01998490
- Sponsor's protocol ID
- 2012/1144
- Status last verified
- Sep 2014
- First submitted
- 19 Nov 2013
- Last updated
- 29 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27434512
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01998490
- Acronym / sponsor ID
- 2012/1144
- Conditions
- Dementia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Norwegian University of Life SciencesUniversity, hospital or other
- Collaborators
- Vestfold University College
- Study start
- Jan 2013
- Primary completion
- May 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 29 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Animal-assisted activity | Experimental | Other: Animal-assisted activity30 minutes group session with animal-assisted activity twice a week for 12 weeks in groups of 4-6 participants. |
| Robot-assisted activity | Experimental | Other: Robot-assisted activity30 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 | No intervention | –Control group with treatment as usual |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Diagnosis of dementia or having a cognitive deficit measured as a score less than 25 on Mini-Mental State Examination.
Key exclusion criteria (3 listed)
- Fear of dogs
- Dog allergy
- Need of wheel chair
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Animal-assisted activity | Other | Animal-assisted activity |
| Robot-assisted activity | Other | Robot-assisted activity |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2014.
- Derived from this study: PubMed 27434512Joranson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Camilla Ihlebæk, PhD principal investigator
Norwegian University of Life Sciences
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Animal-assisted activity and Robot-assisted activity in people with Dementia, run by Norwegian University of Life Sciences at 15 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01998490, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2014.