- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03270592
Assessment of Service and Hearing Dogs
September 1, 2017 updated by: Martina Lundqvist, Linkoeping University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
56
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (ADULT, OLDER_ADULT, CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: Service dogs
Single arm study using a before after design where Before represent having a regular companion dog and after represent having a certified service dog
|
Use of a individualized certified service dog
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total costs
Time Frame: Three months follow-up
|
Health care costs, cost of informal care, municipal costs
|
Three months follow-up
|
Health related quality of life, EQ-5D
Time Frame: Tree months follow-up
|
EQ-5D is a generic quality of life instrument including five dimensions
|
Tree months follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cost-effectiveness
Time Frame: Life time perspective
|
Cost per quality adjusted life years (QALY)
|
Life time perspective
|
Health related quality of life, RAND-36
Time Frame: Three months follow-up
|
RAND-36 is a generic quality of life instrument including eight dimensions
|
Three months follow-up
|
WHO-5 wellbeing index
Time Frame: Three months follow-up
|
WHO-5 wellbeing index is an index measuring wellbeing on five dimensions
|
Three months follow-up
|
Rosenberg self-esteem scale
Time Frame: Three month follow-up
|
Rosenberg self-esteem scale measures self esteem with ten questions
|
Three month follow-up
|
EQ-VAS
Time Frame: Three months follow-up
|
EQ-VAS is a Visual analogue scale ranging from 0 to 100 (perfect Health)
|
Three months follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: Lars-Åke Levin, Professor, Linkoeping University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
September 17, 2009
Primary Completion (ACTUAL)
July 2, 2014
Study Completion (ACTUAL)
July 2, 2014
Study Registration Dates
First Submitted
August 31, 2017
First Submitted That Met QC Criteria
August 31, 2017
First Posted (ACTUAL)
September 1, 2017
Study Record Updates
Last Update Posted (ACTUAL)
September 5, 2017
Last Update Submitted That Met QC Criteria
September 1, 2017
Last Verified
September 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Dnr 157-09
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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