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Assessment of Service and Hearing Dogs

Primary Purpose

Impairment, Diabetes, Epilepsy

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Service dog
Sponsored by
Linkoeping University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Impairment focused on measuring Service dogs, Alert dogs, Costs, Quality of Life, Cost-effectiveness

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age over 16 years
  • Having a regular companion dog
  • Being in need of a certified service dog (due to impairment, diabetes, epilepsy and deafness)

Exclusion Criteria:

  • Psychiatric illness

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Service dogs

    Arm Description

    Single arm study using a before after design where Before represent having a regular companion dog and after represent having a certified service dog

    Outcomes

    Primary Outcome Measures

    Total costs
    Health care costs, cost of informal care, municipal costs
    Health related quality of life, EQ-5D
    EQ-5D is a generic quality of life instrument including five dimensions

    Secondary Outcome Measures

    Cost-effectiveness
    Cost per quality adjusted life years (QALY)
    Health related quality of life, RAND-36
    RAND-36 is a generic quality of life instrument including eight dimensions
    WHO-5 wellbeing index
    WHO-5 wellbeing index is an index measuring wellbeing on five dimensions
    Rosenberg self-esteem scale
    Rosenberg self-esteem scale measures self esteem with ten questions
    EQ-VAS
    EQ-VAS is a Visual analogue scale ranging from 0 to 100 (perfect Health)

    Full Information

    First Posted
    August 31, 2017
    Last Updated
    September 1, 2017
    Sponsor
    Linkoeping University
    Collaborators
    Ministry of Health and Social Affairs, Sweden
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03270592
    Brief Title
    Assessment of Service and Hearing Dogs
    Official Title
    Assessment of Service and Hearing Dogs
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    September 17, 2009 (Actual)
    Primary Completion Date
    July 2, 2014 (Actual)
    Study Completion Date
    July 2, 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Linkoeping University
    Collaborators
    Ministry of Health and Social Affairs, Sweden

    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
    For persons with impairments and certain illnesses the use of service dogs may have positive effect. The effects of using these dogs to assist in every day life need to be studied further.The aim of the study was to assess how health care consumption was effected by using certified service dogs and to study the cost-effectiveness of having a certified service dog.
    Detailed Description
    This is an exploratory before and after study with the aim to study how health care consumption was effected by using certified service dogs and to study the cost-effectiveness of having a certified service dog. Data was collected before the education of the dog started and the follow-up was made three months after completion of the education. Data was collected on Health care consumption and outcomes in terms Health related quality of life and Health outcomes.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Impairment, Diabetes, Epilepsy
    Keywords
    Service dogs, Alert dogs, Costs, Quality of Life, Cost-effectiveness

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    56 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Service dogs
    Arm Type
    Other
    Arm Description
    Single arm study using a before after design where Before represent having a regular companion dog and after represent having a certified service dog
    Intervention Type
    Other
    Intervention Name(s)
    Service dog
    Intervention Description
    Use of a individualized certified service dog
    Primary Outcome Measure Information:
    Title
    Total costs
    Description
    Health care costs, cost of informal care, municipal costs
    Time Frame
    Three months follow-up
    Title
    Health related quality of life, EQ-5D
    Description
    EQ-5D is a generic quality of life instrument including five dimensions
    Time Frame
    Tree months follow-up
    Secondary Outcome Measure Information:
    Title
    Cost-effectiveness
    Description
    Cost per quality adjusted life years (QALY)
    Time Frame
    Life time perspective
    Title
    Health related quality of life, RAND-36
    Description
    RAND-36 is a generic quality of life instrument including eight dimensions
    Time Frame
    Three months follow-up
    Title
    WHO-5 wellbeing index
    Description
    WHO-5 wellbeing index is an index measuring wellbeing on five dimensions
    Time Frame
    Three months follow-up
    Title
    Rosenberg self-esteem scale
    Description
    Rosenberg self-esteem scale measures self esteem with ten questions
    Time Frame
    Three month follow-up
    Title
    EQ-VAS
    Description
    EQ-VAS is a Visual analogue scale ranging from 0 to 100 (perfect Health)
    Time Frame
    Three months follow-up

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Age over 16 years Having a regular companion dog Being in need of a certified service dog (due to impairment, diabetes, epilepsy and deafness) Exclusion Criteria: Psychiatric illness
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Lars-Åke Levin, Professor
    Organizational Affiliation
    Linkoeping University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    29945630
    Citation
    Lundqvist M, Levin LA, Roback K, Alwin J. The impact of service and hearing dogs on health-related quality of life and activity level: a Swedish longitudinal intervention study. BMC Health Serv Res. 2018 Jun 27;18(1):497. doi: 10.1186/s12913-018-3014-0.
    Results Reference
    derived

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    Assessment of Service and Hearing Dogs

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