- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03284580
Effectiveness of a Home-based Ergonomic Intervention Program in Caregivers of Chronic Post-stroke Patients
Effectiveness of a Home-based Ergonomic Intervention Program on Overall Quality of Life, Health Satisfaction, and Home Ergonomics in Caregivers of Chronic Post-stroke Patients: a Randomized Controlled Clinical Trial
Study Overview
Status
Conditions
Detailed Description
Stroke is a neurological pathology that can cause functional problems and an impairment to perform activities of daily living at home.
For this reason, these patients need the support of a caregiver. Caregivers of post-stroke patients often have also problems with their quality of life because of the care that they must provide. These problems appear mainly during the support tasks in the activities performed at the patient's home.
The objective of the present study is to evaluate the effectiveness of two home-based ergonomic intervention programs compared to a control group on the quality of life of caregivers of post-stroke patients
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Córdoba, Spain, 18007
- José Manuel Pérez Mármol
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Being caregivers of post-stroke patients
- Being over 18 years old
Exclusion Criteria:
- Being caregiver of patients with other neurological patients
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ergonomic intervention group
Ergonomic intervention program at home for caregivers
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An ergonomic intervention program focused to caregivers, including recommendation about how they should help themself and the patients activities at home.
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Experimental: Postural + kinesiotherapy intervention group
A postural + kinesiotherapy intervention program at home for caregivers
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An ergonomic intervention program focused to caregivers, including recommendation about how they should help themself and the patients activities at home.
Other Names:
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Other: Control or conservative group
A conservative intervention by general information for caregivers
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A control or conservative intervention, including general information about stroke disease for the caregivers of these patients
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from WhoQol-Bref at 8 weeks
Time Frame: Eight weeks
|
This test measures quality of life
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Eight weeks
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Change from WhoQol-Bref at 16 weeks
Time Frame: Sixteen weeks
|
This test measures quality of life
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Sixteen weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from ergonomic evaluation of the domestic environment at 8 weeks
Time Frame: Eight weeks
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This measurement evaluates if domestic environment is ergonomic
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Eight weeks
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Change from ergonomic evaluation of the domestic environment at 16 weeks
Time Frame: Sixteen weeks
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This measurement evaluates if domestic environment is ergonomic
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Sixteen weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Rehab in carers of post-stroke
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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