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Optimal Dog Visits

Primary Purpose

Dementia, Aging

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Dog visit
Encourage to engage in activity
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Dementia focused on measuring Animal-assisted therapy, visiting dog, non-pharmacological, nursing home

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

• Being able to sit up during the visits

Exclusion Criteria:

  • Dog allergy
  • Fear of dogs
  • Health problems that make participation unadvisable

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Experimental

    Active Comparator

    Arm Label

    1: Dog visit with a dog, no additional activity (D)

    2: Dog visit with an additional activity (DA)

    3: Visit without dog, with an additional activity (A)

    Arm Description

    The nursing home resident receives 12 10-minute visits in their own room. The visitor is accompanied with a dog, and the resident can touch the dog. Apart from the visitor, an observer is present.

    The nursing home resident receives 12 10-minute visits in their own room. The visitor is accompanied with a dog, and the resident can touch the dog. During the visit, the visitor offers the resident to participate in an activity that involves interacting with the dog. Apart from the visitor, an observer is present.

    The nursing home resident receives 12 10-minute visits in their own room. During the visit, the visitor offers the resident to participate in an activity. Apart from the visitor, an observer is present, but no dog is present..

    Outcomes

    Primary Outcome Measures

    Behavioural response during visits
    The behaviour of the residents is recorded by direct observation using continuous recording. In all visits, the frequency and duration of talk and physical contact to the persons present are recorded. Talk is classified into talk about the dog and/or activity, depending on the visit type. In visits with dogs (D, DA), the frequency and duration of physical contact and talk directed to the dog are recorded, and in visits involving an activity (DA, A), the frequency and duration of the residents' involvement in the activity are recorded.

    Secondary Outcome Measures

    Cognitive impairment level, before intervention
    All participants were scored on the Mini-Mental State Examination (MMSE), which gives information about the participants' cognitive status.The MMSE score has a minimum and maximum value of 0 and 30, respectively. The lower the score, the more severe the cognitively impairment level.
    Daily function level, before intervention
    All participants were scored on The Gottfries-Bråne-Steen Scale (GBS), which is an evaluation of disabilities, language, psychiatric symptoms, average daily living function, and behaviour of the participants. The GBS score has a minimum and maximum value of 0 and 156, respectively. The lower the score, the more well-functioning the patient.
    Symptoms of depression, before intervention
    All participants were scored on the Geriatric Depression Scale (GDS), to screen for symptoms of depression. The GDS score has a minimum and maximum value of 0 and 15, respectively.A high score indicates more symptoms of depression.
    Cognitive impairment level, after intervention
    All participants were scored on the Mini-Mental State Examination (MMSE), which gives information about the participants' cognitive status. The MMSE score has a minimum and maximum value of 0 and 30, respectively. The lower the score, the more severe the cognitively impairment level.
    Daily function level,, after intervention
    All participants were scored on The Gottfries-Bråne-Steen Scale (GBS), which is an evaluation of disabilities, language, psychiatric symptoms, average daily living function, and behaviour of the participants. The GBS score has a minimum and maximum value of 0 and 156, respectively. The lower the score, the more well-functioning the patient.
    Symptoms of depression, after intervention
    All participants were scored on the Geriatric Depression Scale (GDS), to screen for symptoms of depression. The GDS score has a minimum and maximum value of 0 and 15, respectively.A high score indicates more symptoms of depression.

    Full Information

    First Posted
    November 16, 2020
    Last Updated
    November 17, 2020
    Sponsor
    University of Aarhus
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04635124
    Brief Title
    Optimal Dog Visits
    Official Title
    Optimal Dog Visits
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2015 (Actual)
    Primary Completion Date
    November 1, 2017 (Actual)
    Study Completion Date
    November 1, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Aarhus

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The aim of this project is to study how an the intensity of dog contact during dog visits in nursing homes can affect the immediate response to, and the general effect of the visits, and whether the residents' level of cognitive impairment affects the response and benefit of dog visits. The participants are randomly assigned to receive one type of visits (12 visits in total) out of three possible visit types (1: visit with a dog; 2: visit with a dog, including a planned activity, 3 visit without a dog, including a planned activity). The residents received 2 visits per week for 6 weeks. The behaviour of the participants during visits is recorded. Before and after the intervention period, participants are scores on psychometric scales for cognitive impairment level, daily function level and symptoms of depression.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dementia, Aging
    Keywords
    Animal-assisted therapy, visiting dog, non-pharmacological, nursing home

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    The design of the study is a stratified and randomized complete block design. Each nursing home is a block. The participants are allocated randomly to one of the three visit types (1) Visits with a dog, no activity (D); 2) Visits with a dog, with activity (DA); or 3) Visits without dog, with an activity (A), balancing for the level of cognitive impairment, measured by the MMSE-scale. This was achieved by ranking the participants according to MMSE score within sex and allocating them to the three visit types by using different numerical orders in each nursing home (1, 2, 3; 3, 1, 2; 2, 3, 1 etc.).
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    186 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1: Dog visit with a dog, no additional activity (D)
    Arm Type
    Active Comparator
    Arm Description
    The nursing home resident receives 12 10-minute visits in their own room. The visitor is accompanied with a dog, and the resident can touch the dog. Apart from the visitor, an observer is present.
    Arm Title
    2: Dog visit with an additional activity (DA)
    Arm Type
    Experimental
    Arm Description
    The nursing home resident receives 12 10-minute visits in their own room. The visitor is accompanied with a dog, and the resident can touch the dog. During the visit, the visitor offers the resident to participate in an activity that involves interacting with the dog. Apart from the visitor, an observer is present.
    Arm Title
    3: Visit without dog, with an additional activity (A)
    Arm Type
    Active Comparator
    Arm Description
    The nursing home resident receives 12 10-minute visits in their own room. During the visit, the visitor offers the resident to participate in an activity. Apart from the visitor, an observer is present, but no dog is present..
    Intervention Type
    Behavioral
    Intervention Name(s)
    Dog visit
    Intervention Description
    An visitor visits the participant with a dog
    Intervention Type
    Behavioral
    Intervention Name(s)
    Encourage to engage in activity
    Intervention Description
    In each visit the visitor invites the participant to engage in an activitty
    Primary Outcome Measure Information:
    Title
    Behavioural response during visits
    Description
    The behaviour of the residents is recorded by direct observation using continuous recording. In all visits, the frequency and duration of talk and physical contact to the persons present are recorded. Talk is classified into talk about the dog and/or activity, depending on the visit type. In visits with dogs (D, DA), the frequency and duration of physical contact and talk directed to the dog are recorded, and in visits involving an activity (DA, A), the frequency and duration of the residents' involvement in the activity are recorded.
    Time Frame
    Behaviour is recorded in all of the 12 visits in the 6 week intervention period
    Secondary Outcome Measure Information:
    Title
    Cognitive impairment level, before intervention
    Description
    All participants were scored on the Mini-Mental State Examination (MMSE), which gives information about the participants' cognitive status.The MMSE score has a minimum and maximum value of 0 and 30, respectively. The lower the score, the more severe the cognitively impairment level.
    Time Frame
    This measure is obtained in the week preceeding the intervention period (6 weeks, 2 visits )
    Title
    Daily function level, before intervention
    Description
    All participants were scored on The Gottfries-Bråne-Steen Scale (GBS), which is an evaluation of disabilities, language, psychiatric symptoms, average daily living function, and behaviour of the participants. The GBS score has a minimum and maximum value of 0 and 156, respectively. The lower the score, the more well-functioning the patient.
    Time Frame
    This measure is obtained in the week preceeding the intervention period (6 weeks, 2 visits )
    Title
    Symptoms of depression, before intervention
    Description
    All participants were scored on the Geriatric Depression Scale (GDS), to screen for symptoms of depression. The GDS score has a minimum and maximum value of 0 and 15, respectively.A high score indicates more symptoms of depression.
    Time Frame
    This measure is obtained in the week preceeding the intervention period (6 weeks, 2 visits )
    Title
    Cognitive impairment level, after intervention
    Description
    All participants were scored on the Mini-Mental State Examination (MMSE), which gives information about the participants' cognitive status. The MMSE score has a minimum and maximum value of 0 and 30, respectively. The lower the score, the more severe the cognitively impairment level.
    Time Frame
    This measure is obtained in the week following the intervention period (6 weeks, 2 visits )
    Title
    Daily function level,, after intervention
    Description
    All participants were scored on The Gottfries-Bråne-Steen Scale (GBS), which is an evaluation of disabilities, language, psychiatric symptoms, average daily living function, and behaviour of the participants. The GBS score has a minimum and maximum value of 0 and 156, respectively. The lower the score, the more well-functioning the patient.
    Time Frame
    This measure is obtained in the week following the intervention period (6 weeks, 2 visits )
    Title
    Symptoms of depression, after intervention
    Description
    All participants were scored on the Geriatric Depression Scale (GDS), to screen for symptoms of depression. The GDS score has a minimum and maximum value of 0 and 15, respectively.A high score indicates more symptoms of depression.
    Time Frame
    This measure is obtained in the week following the intervention period (6 weeks, 2 visits )

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: • Being able to sit up during the visits Exclusion Criteria: Dog allergy Fear of dogs Health problems that make participation unadvisable
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Karen Thodberg
    Organizational Affiliation
    University of Aarhus
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Optimal Dog Visits

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