Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Animal-assisted Interventions in Health Promotion for Elderly With Dementia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02008630
Recruitment Status : Completed
First Posted : December 11, 2013
Last Update Posted : September 29, 2014
Sponsor:
Information provided by (Responsible Party):
Camilla Ihlebæk, Norwegian University of Life Sciences

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. 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. 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. 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. 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?

Condition or disease Intervention/treatment Phase
Dementia Other: Animal-assisted activity Other: Animal-assisted therapy Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 122 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Animal-assisted Interventions in Health Promotion for Elderly With Dementia; Impact on Factors Related to Risk of Falls
Study Start Date : January 2013
Actual Primary Completion Date : May 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

Arm Intervention/treatment
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
Experimental: Animal-assisted therapy
30 minutes group session with animal-assisted therapy twice a week for 12 weeks in groups of 4-6 participants
Other: Animal-assisted therapy
No Intervention: Control
Control group with treatment as usual



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Other Outcome Measures:
  1. Change in physical activity measured by 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. Will be used to calculate physical activity during day time and sleep efficacy during the night.

  2. Video recordings of two group session at each location [ Time Frame: After two and ten weeks of the intervention ]
    The video recordings will be analyzed with respect to social interaction and group dynamics

  3. Change in optional and ordinary medication [ Time Frame: 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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 or need of wheel chair

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02008630


Locations
Show Show 21 study locations
Sponsors and Collaborators
Norwegian University of Life Sciences
Investigators
Layout table for investigator information
Principal Investigator: Camilla Ihlebæk, PhD Norwegian University of Life Sciences

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Camilla Ihlebæk, Professor, Norwegian University of Life Sciences
ClinicalTrials.gov Identifier: NCT02008630    
Other Study ID Numbers: 2012/1144-1
First Posted: December 11, 2013    Key Record Dates
Last Update Posted: September 29, 2014
Last Verified: September 2014
Additional relevant MeSH terms:
Layout table for MeSH terms
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders