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A Telerehabilitation Intervention to Improve Activity and Participation Among Adults Following Acquired Brain Injury

Primary Purpose

Brain Injury, Chronic

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
The Cognitive Orientation to daily Occupational Performance
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Injury, Chronic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

(1) ≥ 6 months post-ABI; (2) age ≥ 18 years; (3) sufficient proficiency in Hebrew or English to participate in the study; (4) modified Rankin scale (mRS) scores of 2-4 reflecting slight to moderate disability [38]; (5) self-reported unmet functional goals; (6) internet access at home; and (7) had an adult significant other who agreed to be involved in the study

Exclusion Criteria:

(1) moderate or severe aphasia; (2) a score of <21 on the Mini Mental Status Examination (MMSE) or Montreal Cognitive Assessment scores: MOCA<19; (3) dementia diagnosis; (3) an acute illness which significantly impacts the ability to participate in the study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Tele-CO-OP

    Waitlist control

    Arm Description

    The intervention included weekly videoconferencing sessions using the Cognitive Orientation to Daily Occupational Performance approach (tele-CO-OP) over a period of three months. Participant identified five functional goals, of which three were directly addressed.

    The waitlist control group did not receive the intervention during the same time period

    Outcomes

    Primary Outcome Measures

    The Canadian Occupational Performance Measure (COPM)
    The COPM is a semi-structured interview to facilitate client-centered goal setting and measure the client's perceived occupational performance and satisfaction levels.
    The Performance Quality Rating Scale (PQRS)
    The PQRS is an observational measure of activity performance.
    The Mayo-Portland Adaptability Inventory (MPAI-4)
    The MPAI-4 measures the recovery progress of people after an ABI and includes 29 items grouped into three subscales: (a) Ability (e.g., motor, sensory and cognitive abilities), (b) Adaptation (e.g., emotional state and social interactions), and (c) Participation (e.g., leisure activities, employment and transportation).

    Secondary Outcome Measures

    The Dysexecutive Questionnaire (DEX)
    The DEX is a 20-item questionnaire to assess executive function in daily life among people with ABI
    The New General Self-Efficacy Scale (NGSE)
    This is an 8-item questionnaire that assesses people's confidence in their ability to accomplish their goals, regardless of the obstacles they may face
    the Short Form Zarit Burden Interview
    A measure of caregiver burden

    Full Information

    First Posted
    November 28, 2016
    Last Updated
    January 17, 2022
    Sponsor
    Hadassah Medical Organization
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02977624
    Brief Title
    A Telerehabilitation Intervention to Improve Activity and Participation Among Adults Following Acquired Brain Injury
    Official Title
    Effectiveness of a Telerehabilitation Intervention to Improve Activity and Participation Among Adults Following Acquired Brain Injury
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2016 (Actual)
    Primary Completion Date
    December 2020 (Actual)
    Study Completion Date
    December 2020 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Hadassah Medical Organization

    4. Oversight

    5. Study Description

    Brief Summary
    Objectives - To evaluate the effectiveness of an telerehabilitation intervention program among acquired brain injury (ABI) survivors in the chronic phase. The aim of the intervention is to improve the transition from rehabilitation units to community dwelling and facilitate activity and participation in life roles in the community. Working hypothesis - The telerehabilitation based program for ABI survivors will be effective in: Improving function in activities of daily living, participation in occupations and health related quality of life. Reducing the need for outpatient clinic and rehabilitation services. The intervention achievements will be maintained in 3-month follow-up Methodology - Participants: ABI survivors will be selected from patients who are referred to the outpatient or home-based rehabilitation unit of Maccabi health services. Following completion of out-patient occupational therapy treatment in the rehabilitation centers the participants will be randomly assigned into two groups: The treatment group will receive the intervention program in addition to standard care, and the waitlist control group will receive standard care only. Outcome measures: The Canadian Occupational Performance Measure (COPM) The Performance Quality Rating Scale (PQRS) Mayo-Portland Adaptability Inventory (MPAI-4) The Dysexecutive Questionnaire (DEX) The New General Self-Efficacy Scale (NGSE) The Zarit Caregiver Burden Scale short version Procedure: The intervention program includes up to 20 video sessions over 3 months between an occupational therapist and the participant. The virtual meetings will be conducted using The Cognitive Orientation to daily Occupational Performance approach. The meetings will focus on problem solving for daily life situations and on the ability to implement the discussed strategies for a variety of activities. Participants will be evaluated at baseline, after the intervention, and after 6 months.
    Detailed Description
    The intervention program includes up to 20 video sessions over 3 months between an occupational therapist and the participant. The virtual meetings will be conducted using The Cognitive Orientation to daily Occupational Performance approach. The meetings will focus on problem solving for daily life situations and on the ability to implement the discussed strategies for a variety of activities. Participants will be evaluated at baseline, after the intervention, and after 6 months.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Brain Injury, Chronic

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Model Description
    This exploratory study was a partially randomized controlled trial with a waitlist control crossover design.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    25 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Tele-CO-OP
    Arm Type
    Experimental
    Arm Description
    The intervention included weekly videoconferencing sessions using the Cognitive Orientation to Daily Occupational Performance approach (tele-CO-OP) over a period of three months. Participant identified five functional goals, of which three were directly addressed.
    Arm Title
    Waitlist control
    Arm Type
    No Intervention
    Arm Description
    The waitlist control group did not receive the intervention during the same time period
    Intervention Type
    Behavioral
    Intervention Name(s)
    The Cognitive Orientation to daily Occupational Performance
    Primary Outcome Measure Information:
    Title
    The Canadian Occupational Performance Measure (COPM)
    Description
    The COPM is a semi-structured interview to facilitate client-centered goal setting and measure the client's perceived occupational performance and satisfaction levels.
    Time Frame
    6 months: baseline, post intervention (after 3 months), follow-up (after 3 more months)
    Title
    The Performance Quality Rating Scale (PQRS)
    Description
    The PQRS is an observational measure of activity performance.
    Time Frame
    6 months: baseline, post intervention (after 3 months), follow-up (after 3 more months)
    Title
    The Mayo-Portland Adaptability Inventory (MPAI-4)
    Description
    The MPAI-4 measures the recovery progress of people after an ABI and includes 29 items grouped into three subscales: (a) Ability (e.g., motor, sensory and cognitive abilities), (b) Adaptation (e.g., emotional state and social interactions), and (c) Participation (e.g., leisure activities, employment and transportation).
    Time Frame
    6 months: baseline, post intervention (after 3 months), follow-up (after 3 more months)
    Secondary Outcome Measure Information:
    Title
    The Dysexecutive Questionnaire (DEX)
    Description
    The DEX is a 20-item questionnaire to assess executive function in daily life among people with ABI
    Time Frame
    6 months: baseline, post intervention (after 3 months), follow-up (after 3 more months)
    Title
    The New General Self-Efficacy Scale (NGSE)
    Description
    This is an 8-item questionnaire that assesses people's confidence in their ability to accomplish their goals, regardless of the obstacles they may face
    Time Frame
    6 months: baseline, post intervention (after 3 months), follow-up (after 3 more months)
    Title
    the Short Form Zarit Burden Interview
    Description
    A measure of caregiver burden
    Time Frame
    6 months: baseline, post intervention (after 3 months), follow-up (after 3 more months)
    Other Pre-specified Outcome Measures:
    Title
    Satisfaction questionnaire
    Description
    A measure of the participants' satisfaction with the tele-CO-OP intervention
    Time Frame
    Post intervention
    Title
    Background questionnaire
    Description
    A questionnaire to document sociodemographic and clinical characteristics
    Time Frame
    6 months: baseline, post intervention (after 3 months), follow-up (after 3 more months)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: (1) ≥ 6 months post-ABI; (2) age ≥ 18 years; (3) sufficient proficiency in Hebrew or English to participate in the study; (4) modified Rankin scale (mRS) scores of 2-4 reflecting slight to moderate disability [38]; (5) self-reported unmet functional goals; (6) internet access at home; and (7) had an adult significant other who agreed to be involved in the study Exclusion Criteria: (1) moderate or severe aphasia; (2) a score of <21 on the Mini Mental Status Examination (MMSE) or Montreal Cognitive Assessment scores: MOCA<19; (3) dementia diagnosis; (3) an acute illness which significantly impacts the ability to participate in the study.

    12. IPD Sharing Statement

    Learn more about this trial

    A Telerehabilitation Intervention to Improve Activity and Participation Among Adults Following Acquired Brain Injury

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