DementiaNCT02008630
Animal-assisted Interventions in Health Promotion for Elderly With Dementia
A study testing Animal-assisted activity and Animal-assisted therapy in people with Dementia, run by Norwegian University of Life Sciences at 21 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 interventions. Also relatives' experience of own and the elderly's situation during and after the intervention will be examined. 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 Animal-assisted therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 21 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 or need of wheel chair
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
Norway21 sites
Solgården Dagsenter
Asker
Lommedalen dagsenter
Bærum
Vallerhjemmet dagsenter
Bærum
Pålsetunet dagsenter
Fet
Fjerdingby dagsenter
Fjerdingby
Glemmen dagsenter
Fredrikstad
Tjølling dagsenter
Larvik
Husebyjordet dagsenter
Lillestrøm
Åråsveien dagsenter
Lillestrøm
Myraveien Dagsenter
Moss
Skogbrynet dagsenter
Moss
Dagsenter Nedre Eiker
Nedre Eiker
Nes Dagsenter
Nes
Bjønnesåsen Dagsenter
Nøtterøy
Bjørkås dagsenter
Oppegård
Re Dagsenter
Re
Sandetun dagsenter
Sande
Lunden dagsenter
Sandefjord
Sørvald dagsenter
Sørum
Eik dagsenter
Tønsberg
Nes dagsenter
Tønsberg
About this study
Official title: Animal-assisted Interventions in Health Promotion for Elderly With Dementia; Impact on Factors Related to Risk of Falls
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 interventions. Also relatives' experience of own and the elderly's situation during and after the intervention will be examined. 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 day care centers diagnosed with dementia, or having a cognitive deficit. The intervention will consist of 30 minutes sessions with animal-assisted activity or animal-assisted therapy 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 day care centers participating in animal-assisted interventions compared to a control group?
- Is there an effect on social interaction, quality of life, activeness and wellbeing among elderly persons with dementia at day care centers participating in animal-assisted interventions compared to a control group?
- Is there an effect on balance among elderly persons with dementia at day care centers participating in animal-assisted therapy compared to animal-assisted activity or a control group?
- Do relatives of elderly persons with dementia at day care centers experience a change in their own and the elderly's situation after the intervention compared with before the intervention started?
- Conditions
- Dementia
- Being tested
- Animal-assisted activity, Animal-assisted therapy
- 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
Animal-assisted therapyOther
| 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 |
| Animal-assisted therapy | Experimental | 30 minutes group session with animal-assisted therapy twice a week for 12 weeks in groups of 4-6 participants Receives: Other: Animal-assisted therapy |
| 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 Berg balance test
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
Secondary outcomes (1)
Change in Norwegian version of Quality of Life in Late-Stage Dementia (QUALID)
Measured: 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 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 posted11 Dec 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
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Life Sciences
- Sponsor type
- University, hospital or other
- 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
- NCT02008630
- Sponsor's protocol ID
- 2012/1144-1
- Status last verified
- Sep 2014
- First submitted
- 6 Dec 2013
- Last updated
- 29 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Olsen C, Pedersen I, Bergland A, Enders-Slegers MJ, Ihlebaek C. Effect of animal-assisted activity on balance and quality of life in home-dwelling persons with dementia. Geriatr Nurs. 2016 Jul-Aug;37(4):284-91. doi: 10.1016/j.gerinurse.2016.04.002. Epub 2016 May 4.
PubMed 27155968
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 Interventions in Health Promotion for Elderly With Dementia; Impact on Factors Related to Risk of Falls
- ClinicalTrials.gov ID
- NCT02008630
- Acronym / sponsor ID
- 2012/1144-1
- Conditions
- Dementia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Norwegian University of Life SciencesUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- May 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 11 Dec 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 interventions. Also relatives' experience of own and the elderly's situation during and after the intervention will be examined. 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 day care centers diagnosed with dementia, or having a cognitive deficit. The intervention will consist of 30 minutes sessions with animal-assisted activity or animal-assisted therapy 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 day care centers participating in animal-assisted interventions compared to a control group?
- Is there an effect on social interaction, quality of life, activeness and wellbeing among elderly persons with dementia at day care centers participating in animal-assisted interventions compared to a control group?
- Is there an effect on balance among elderly persons with dementia at day care centers participating in animal-assisted therapy compared to animal-assisted activity or a control group?
- Do relatives of elderly persons with dementia at day care centers experience a change in their own and the elderly's situation after the intervention compared with before the intervention started?
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. |
| Animal-assisted therapy | Experimental | Other: Animal-assisted therapy30 minutes group session with animal-assisted therapy 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 (1 listed)
- Fear of dogs, dog allergy or 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 |
| Animal-assisted therapy | Other | Animal-assisted therapy |
Primary outcome
Change in Norwegian version of Berg balance test
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
1 secondary outcome
Change in Norwegian version of Quality of Life in Late-Stage Dementia (QUALID)
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 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 27155968Olsen C, Pedersen I, Bergland A, Enders-Slegers MJ, Ihlebaek C. Effect of animal-assisted activity on balance and quality of life in home-dwelling persons with dementia. Geriatr Nurs. 2016 Jul-Aug;37(4):284-91. doi: 10.1016/j.gerinurse.2016.04.002. Epub 2016 May 4.
Related trials for Dementia
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
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
21 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 Animal-assisted therapy in people with Dementia, run by Norwegian University of Life Sciences at 21 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 1 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 21 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 Berg balance test (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 NCT02008630, 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.