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Completed

NCT Number: NCT01998490

Animal-assisted or Robot-assisted Interventions in Health Promotion for Elderly With Dementia

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?

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Key information

Conditions

Dementia Brain Diseases Central Nervous System Diseases Mental Disorders Nervous System Diseases Neurocognitive Disorders

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pålsetunet bo- og servicesenter, Fet, Norway

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

animal-assisted activity

Other

Robot-assisted activity

Other

Primary outcomes

  1. 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

Other outcomes

  1. 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

  2. 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

  3. 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.

  4. 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.

  5. 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

  6. 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

Sponsors and collaborators

Lead sponsor

Norwegian University of Life Sciences

Other

Collaborators

  • Vestfold University College

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Nov 29, 2013
Registry last updated
Sep 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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