Effectiveness of a Home-based Ergonomic Intervention Program in Caregivers of Chronic Post-stroke Patients

September 14, 2017 updated by: José Manuel Pérez Mármol, Universidad de Granada

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Córdoba, Spain, 18007
        • José Manuel Pérez Mármol

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

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: 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
Other: Ergonomic intervention
An ergonomic intervention program focused to caregivers, including recommendation about how they should help themself and the patients activities at home.
Experimental: Postural + kinesiotherapy intervention group
A postural + kinesiotherapy intervention program at home for caregivers
Other: Postural plus kinesiotherapy intervention program
An ergonomic intervention program focused to caregivers, including recommendation about how they should help themself and the patients activities at home.
Other Names:
  • A postural plus kinesiotherapy intervention program, including excercises for caregivers
Other: Control or conservative group
A conservative intervention by general information for caregivers
Other: Control or conservative intervention
A control or conservative intervention, including general information about stroke disease for the caregivers of these patients

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
Eight weeks
Change from WhoQol-Bref at 16 weeks
Time Frame: Sixteen weeks
This test measures quality of life
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
This measurement evaluates if domestic environment is ergonomic
Eight weeks
Change from ergonomic evaluation of the domestic environment at 16 weeks
Time Frame: Sixteen weeks
This measurement evaluates if domestic environment is ergonomic
Sixteen weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad de Granada

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.

General Publications

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)

January 8, 2017

Primary Completion (Actual)

August 9, 2017

Study Completion (Actual)

August 20, 2017

Study Registration Dates

First Submitted

September 13, 2017

First Submitted That Met QC Criteria

September 14, 2017

First Posted (Actual)

September 15, 2017

Study Record Updates

Last Update Posted (Actual)

September 15, 2017

Last Update Submitted That Met QC Criteria

September 14, 2017

Last Verified

September 1, 2017

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

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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