NCT02008630

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 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:

  1. 1.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?
  2. 2.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?
  3. 3.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?
  4. 4.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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

21 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 6, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 11, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

September 29, 2014

Status Verified

September 1, 2014

Enrollment Period

1.3 years

First QC Date

December 6, 2013

Last Update Submit

September 26, 2014

Conditions

Dementia

Outcome Measures

Primary Outcomes (1)

  • Change in Norwegian version of Berg balance test

    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)

    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

Other Outcomes (3)

  • Change in physical activity measured by Actigraphy

    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 of two group session at each location

    After two and ten weeks of the intervention

  • Change in optional and ordinary medication

    Second last or last week before the intervention starts, first or second week after the end of intervention. A follow-up measure 3 months after end of the intervention

Study Arms (3)

Animal-assisted activity

EXPERIMENTAL

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

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

Other: Animal-assisted therapy

Control

NO INTERVENTION

Control group with treatment as usual

Interventions

Animal-assisted activityOTHER
Animal-assisted activity
Animal-assisted therapyOTHER
Animal-assisted therapy

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Diagnosis of dementia or having a cognitive deficit measured as a score less than 25 on Mini-Mental State Examination.

You may not qualify if:

  • Fear of dogs, dog allergy or need of wheel chair

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (21)

Solgården Dagsenter

Asker, Norway

Location

Lommedalen dagsenter

Bærum, Norway

Location

Vallerhjemmet dagsenter

Bærum, Norway

Location

Pålsetunet dagsenter

Fet, Norway

Location

Fjerdingby dagsenter

Fjerdingby, Norway

Location

Glemmen dagsenter

Fredrikstad, Norway

Location

Tjølling dagsenter

Larvik, Norway

Location

Husebyjordet dagsenter

Lillestrøm, Norway

Location

Åråsveien dagsenter

Lillestrøm, Norway

Location

Myraveien Dagsenter

Moss, Norway

Location

Skogbrynet dagsenter

Moss, Norway

Location

Dagsenter Nedre Eiker

Nedre Eiker, Norway

Location

Nes Dagsenter

Nes, Norway

Location

Bjønnesåsen Dagsenter

Nøtterøy, Norway

Location

Bjørkås dagsenter

Oppegård, Norway

Location

Re Dagsenter

Re, Norway

Location

Sandetun dagsenter

Sande, Norway

Location

Lunden dagsenter

Sandefjord, Norway

Location

Sørvald dagsenter

Sørum, Norway

Location

Eik dagsenter

Tønsberg, Norway

Location

Nes dagsenter

Tønsberg, Norway

Location

Related Publications (1)

  • 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.

    PMID: 27155968DERIVED

MeSH Terms

Conditions

Dementia

Interventions

Animal Assisted Therapy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPsychotherapyBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Camilla Ihlebæk, PhD

    Norwegian University of Life Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 6, 2013

First Posted

December 11, 2013

Study Start

January 1, 2013

Primary Completion

May 1, 2014

Study Completion

August 1, 2014

Last Updated

September 29, 2014

Record last verified: 2014-09

Locations

NO(21)