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

Study Overview
=================
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.

Official Title
-----------------
Effectiveness of a Telerehabilitation Intervention to Improve Activity and Participation Among Adults Following Acquired Brain Injury

Conditions
-----------------
Brain Injury, Chronic

Intervention / Treatment
-----------------
* Behavioral: The Cognitive Orientation to daily Occupational Performance


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: This exploratory study was a partially randomized controlled trial with a waitlist control crossover design.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tele-CO-OP<br>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. | Behavioral: The Cognitive Orientation to daily Occupational Performance<br> <br> |
| No Intervention: Waitlist control<br>The waitlist control group did not receive the intervention during the same time period | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months: baseline, post intervention (after 3 months), follow-up (after 3 more months) | 
| The Performance Quality Rating Scale (PQRS) | The PQRS is an observational measure of activity performance. | 6 months: baseline, post intervention (after 3 months), follow-up (after 3 more months) | 
| 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). | 6 months: baseline, post intervention (after 3 months), follow-up (after 3 more months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Dysexecutive Questionnaire (DEX) | The DEX is a 20-item questionnaire to assess executive function in daily life among people with ABI | 6 months: baseline, post intervention (after 3 months), follow-up (after 3 more months) | 
| 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 | 6 months: baseline, post intervention (after 3 months), follow-up (after 3 more months) | 
| the Short Form Zarit Burden Interview | A measure of caregiver burden | 6 months: baseline, post intervention (after 3 months), follow-up (after 3 more months) |