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

Primary Purpose

Stroke, Quality of Life

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Ergonomic intervention
Postural plus kinesiotherapy intervention program
Control or conservative intervention
Sponsored by
Universidad de Granada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Being caregivers of post-stroke patients
  • Being over 18 years old

Exclusion Criteria:

  • Being caregiver of patients with other neurological patients

Sites / Locations

  • José Manuel Pérez Mármol

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Other

Arm Label

Ergonomic intervention group

Postural + kinesiotherapy intervention group

Control or conservative group

Arm Description

Ergonomic intervention program at home for caregivers

A postural + kinesiotherapy intervention program at home for caregivers

A conservative intervention by general information for caregivers

Outcomes

Primary Outcome Measures

Change from WhoQol-Bref at 8 weeks
This test measures quality of life
Change from WhoQol-Bref at 16 weeks
This test measures quality of life

Secondary Outcome Measures

Change from ergonomic evaluation of the domestic environment at 8 weeks
This measurement evaluates if domestic environment is ergonomic
Change from ergonomic evaluation of the domestic environment at 16 weeks
This measurement evaluates if domestic environment is ergonomic

Full Information

First Posted
September 13, 2017
Last Updated
September 14, 2017
Sponsor
Universidad de Granada
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1. Study Identification

Unique Protocol Identification Number
NCT03284580
Brief Title
Effectiveness of a Home-based Ergonomic Intervention Program in Caregivers of Chronic Post-stroke Patients
Official Title
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 Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
January 8, 2017 (Actual)
Primary Completion Date
August 9, 2017 (Actual)
Study Completion Date
August 20, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Granada

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Quality of Life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ergonomic intervention group
Arm Type
Experimental
Arm Description
Ergonomic intervention program at home for caregivers
Arm Title
Postural + kinesiotherapy intervention group
Arm Type
Experimental
Arm Description
A postural + kinesiotherapy intervention program at home for caregivers
Arm Title
Control or conservative group
Arm Type
Other
Arm Description
A conservative intervention by general information for caregivers
Intervention Type
Other
Intervention Name(s)
Ergonomic intervention
Intervention Description
An ergonomic intervention program focused to caregivers, including recommendation about how they should help themself and the patients activities at home.
Intervention Type
Other
Intervention Name(s)
Postural plus kinesiotherapy intervention program
Other Intervention Name(s)
A postural plus kinesiotherapy intervention program, including excercises for caregivers
Intervention Description
An ergonomic intervention program focused to caregivers, including recommendation about how they should help themself and the patients activities at home.
Intervention Type
Other
Intervention Name(s)
Control or conservative intervention
Intervention Description
A control or conservative intervention, including general information about stroke disease for the caregivers of these patients
Primary Outcome Measure Information:
Title
Change from WhoQol-Bref at 8 weeks
Description
This test measures quality of life
Time Frame
Eight weeks
Title
Change from WhoQol-Bref at 16 weeks
Description
This test measures quality of life
Time Frame
Sixteen weeks
Secondary Outcome Measure Information:
Title
Change from ergonomic evaluation of the domestic environment at 8 weeks
Description
This measurement evaluates if domestic environment is ergonomic
Time Frame
Eight weeks
Title
Change from ergonomic evaluation of the domestic environment at 16 weeks
Description
This measurement evaluates if domestic environment is ergonomic
Time Frame
Sixteen weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Being caregivers of post-stroke patients Being over 18 years old Exclusion Criteria: Being caregiver of patients with other neurological patients
Facility Information:
Facility Name
José Manuel Pérez Mármol
City
Córdoba
ZIP/Postal Code
18007
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
29452985
Citation
de Araujo Freitas Moreira KL, Abalos-Medina GM, Villaverde-Gutierrez C, Gomes de Lucena NM, Belmont Correia de Oliveira A, Perez-Marmol JM. Effectiveness of two home ergonomic programs in reducing pain and enhancing quality of life in informal caregivers of post-stroke patients: A pilot randomized controlled clinical trial. Disabil Health J. 2018 Jul;11(3):471-477. doi: 10.1016/j.dhjo.2018.01.003. Epub 2018 Feb 13.
Results Reference
derived

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

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