NCT03284580

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Jan 2017

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 8, 2017

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 9, 2017

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2017

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2017

Completed
Last Updated

September 15, 2017

Status Verified

September 1, 2017

Enrollment Period

7 months

First QC Date

September 13, 2017

Last Update Submit

September 14, 2017

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change from WhoQol-Bref at 8 weeks

    This test measures quality of life

    Eight weeks

  • Change from WhoQol-Bref at 16 weeks

    This test measures quality of life

    Sixteen weeks

Secondary Outcomes (2)

  • Change from ergonomic evaluation of the domestic environment at 8 weeks

    Eight weeks

  • Change from ergonomic evaluation of the domestic environment at 16 weeks

    Sixteen weeks

Study Arms (3)

Ergonomic intervention group

EXPERIMENTAL

Ergonomic intervention program at home for caregivers

Other: Ergonomic intervention

Postural + kinesiotherapy intervention group

EXPERIMENTAL

A postural + kinesiotherapy intervention program at home for caregivers

Other: Postural plus kinesiotherapy intervention program

Control or conservative group

OTHER

A conservative intervention by general information for caregivers

Other: Control or conservative intervention

Interventions

An ergonomic intervention program focused to caregivers, including recommendation about how they should help themself and the patients activities at home.

Ergonomic intervention group

An ergonomic intervention program focused to caregivers, including recommendation about how they should help themself and the patients activities at home.

Also known as: A postural plus kinesiotherapy intervention program, including excercises for caregivers
Postural + kinesiotherapy intervention group

A control or conservative intervention, including general information about stroke disease for the caregivers of these patients

Control or conservative group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Being caregiver of patients with other neurological patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

José Manuel Pérez Mármol

Córdoba, 18007, Spain

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Stroke

Interventions

Caregivers

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Health PersonnelHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 13, 2017

First Posted

September 15, 2017

Study Start

January 8, 2017

Primary Completion

August 9, 2017

Study Completion

August 20, 2017

Last Updated

September 15, 2017

Record last verified: 2017-09

Locations