ImpairmentNCT03270592
Assessment of Service and Hearing Dogs
A study testing Service dog in people with Impairment and Diabetes, run by Linkoeping University.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Impairment, Diabetes, Epilepsy
- What is being tested?
- Service dog
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- 17 Sep 2009to 2 Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age over 16 years
- Having a regular companion dog
- Being in need of a certified service dog (due to impairment, diabetes, epilepsy and deafness)
Who cannot join
- Psychiatric illness
About this study
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.
Read the 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.
- Conditions
- Impairment, Diabetes, Epilepsy
- Being tested
- Service dog
- Keywords
- Service dogs, Alert dogs, Costs, Quality of Life, Cost-effectiveness
- Medical subject headings
- Diabetes Mellitus, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Service dogOther
Use of a individualized certified service dog
| Study group | Role | What they receive |
|---|---|---|
| Service dogs | Other | Single arm study using a before after design where Before represent having a regular companion dog and after represent having a certified service dog Receives: Other: Service dog |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total costs
Health care costs, cost of informal care, municipal costs
Measured: Three months follow-up
Health related quality of life, EQ-5D
EQ-5D is a generic quality of life instrument including five dimensions
Measured: Tree months follow-up
Secondary outcomes (5)
Cost-effectiveness
Cost per quality adjusted life years (QALY)
Measured: Life time perspective
Health related quality of life, RAND-36
RAND-36 is a generic quality of life instrument including eight dimensions
Measured: Three months follow-up
WHO-5 wellbeing index
WHO-5 wellbeing index is an index measuring wellbeing on five dimensions
Measured: Three months follow-up
Rosenberg self-esteem scale
Rosenberg self-esteem scale measures self esteem with ten questions
Measured: Three month follow-up
EQ-VAS
EQ-VAS is a Visual analogue scale ranging from 0 to 100 (perfect Health)
Measured: Three months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2017
- Study start17 Sep 2009
- Primary completion2 Jul 2014
- Study completion2 Jul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ImpairmentStudies of the same condition, open and under way.
- More trials run by Linkoeping UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Collaborators
- Ministry of Health and Social Affairs, Sweden
- Responsible party
- Principal investigator, Martina Lundqvist, Linkoeping University
- Investigators
- Lars-Åke Levin, Professor, Study director, Linkoeping University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03270592
- Sponsor's protocol ID
- Dnr 157-09
- Status last verified
- Sep 2017
- First submitted
- 31 Aug 2017
- Last updated
- 5 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29945630
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Service and Hearing Dogs
- ClinicalTrials.gov ID
- NCT03270592
- Acronym / sponsor ID
- Dnr 157-09
- Conditions
- Impairment, Diabetes, Epilepsy
- Keywords
- Service dogs, Alert dogs, Costs, Quality of Life, Cost-effectiveness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Linkoeping UniversityOther government
- Collaborators
- Ministry of Health and Social Affairs, Sweden
- Study start
- 17 Sep 2009 (actual)
- Primary completion
- 2 Jul 2014 (actual)
- Study completion
- 2 Jul 2014 (actual)
- First posted
- 1 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Service dogs | Other | Other: Service dogSingle arm study using a before after design where Before represent having a regular companion dog and after represent having a certified service dog |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Age over 16 years
- Having a regular companion dog
- Being in need of a certified service dog (due to impairment, diabetes, epilepsy and deafness)
Key exclusion criteria (1 listed)
- Psychiatric illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Service dogUse of a individualized certified service dog | Other | Service dogs |
Primary outcome
Total costs
Time frame: Three months follow-up
Health care costs, cost of informal care, municipal costs
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
5 secondary outcomes
Cost-effectiveness
Time frame: Life time perspective
Health related quality of life, RAND-36
Time frame: Three months follow-up
WHO-5 wellbeing index
Time frame: Three months follow-up
Rosenberg self-esteem scale
Time frame: Three month follow-up
EQ-VAS
Time frame: Three months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2017.
- Derived from this study: PubMed 29945630Lundqvist 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lars-Åke Levin, Professor study director
Linkoeping University
Questions about this trial
What is this clinical trial studying?
A study testing Service dog in people with Impairment and Diabetes, run by Linkoeping University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total costs (time frame: Three months follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03270592, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2017; AzTrials last refreshed its copy on 6 Nov 2026.