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Clinical Trials/NCT04586842
NCT04586842
Unknown
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Study Protocol For A Non-Randomised Controlled Trial: A Community-Based Occupational Therapy Intervention On Mental Health For People With Acquired Brain Injury (COT-MHABI)

Institut Guttmann1 site in 1 country134 target enrollmentSeptember 1, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Acquired Brain Injury
Sponsor
Institut Guttmann
Enrollment
134
Locations
1
Primary Endpoint
Canadian Occupational Performance Measure, spanish version (COPM)
Last Updated
3 years ago

Overview

Brief Summary

The main purpose of this research project is to analyze the effectiveness of a Community-based Occupational Therapy Intervention on mental health for people with acquired brain injury. To this end, variables such as quality of life, occupational performance and balance, participation in significant roles and community integration will be measured.

The research will be carried out as a non-randomized controlled trial study in which the participants in the experimental arm will receive a community-based occupational therapy intervention (domiciliary and telehealth intervention sessions) based on the stages of the Human Occupation Model's Remotivation Process. The participants at the control arm will receive the regular (public or private) services provision for this population profile.

It is expected to be able to demonstrate the effectiveness of the intervention based on a positive result in the change in the variables, so as to increase the chance and performance of occupational participation after the acquired brain injury. Also, it is intended that families and the community are key elements of agency and support in occupational participation.

Registry
clinicaltrials.gov
Start Date
September 1, 2020
End Date
September 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Institut Guttmann
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Canadian Occupational Performance Measure, spanish version (COPM)

Time Frame: 1 year

This scale is an evidence-based outcome measure designed to capture a client's self-perception of performance in everyday living, over time.

World Health Organization Quality of Life-BREF, spanish version (WHOQoL-BREF)

Time Frame: 1 year

This scale provides a profile of quality of life perceived by the subject.

Secondary Outcomes

  • Community Integration Questionnaire, spanish version (CIQ)(1 year)
  • Activity Card Sort, spanish version (ACS)(1 year)
  • Satisfaction with Daily Occupations and Occupational Balance, spanish version (SOD-EO)(1 year)
  • Role Checklist Version 3 (RCV3)(1 year)
  • Functional Independence Measure (FIM)(1 year)

Study Sites (1)

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