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Completed

NCT Number: NCT02977624

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

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:

1. Improving function in activities of daily living, participation in occupations and health related quality of life. 2. Reducing the need for outpatient clinic and rehabilitation services. 3. 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:

1. The Canadian Occupational Performance Measure (COPM) 2. The Performance Quality Rating Scale (PQRS) 3. Mayo-Portland Adaptability Inventory (MPAI-4) 4. The Dysexecutive Questionnaire (DEX) 5. The New General Self-Efficacy Scale (NGSE) 6. 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.

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Key information

Conditions

Brain Injury, Chronic Brain Damage, Chronic Brain Diseases Brain Injuries Central Nervous System Diseases Chronic Disease Craniocerebral Trauma Disease Attributes Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

The Cognitive Orientation to daily Occupational Performance

Behavioral

Primary outcomes

  1. The Canadian Occupational Performance Measure (COPM)

    Time frame: 6 months: baseline, post intervention (after 3 months), follow-up (after 3 more months)

    The COPM is a semi-structured interview to facilitate client-centered goal setting and measure the client's perceived occupational performance and satisfaction levels.

  2. The Performance Quality Rating Scale (PQRS)

    Time frame: 6 months: baseline, post intervention (after 3 months), follow-up (after 3 more months)

    The PQRS is an observational measure of activity performance.

  3. The Mayo-Portland Adaptability Inventory (MPAI-4)

    Time frame: 6 months: baseline, post intervention (after 3 months), follow-up (after 3 more months)

    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 outcomes

  1. The Dysexecutive Questionnaire (DEX)

    Time frame: 6 months: baseline, post intervention (after 3 months), follow-up (after 3 more months)

    The DEX is a 20-item questionnaire to assess executive function in daily life among people with ABI

  2. The New General Self-Efficacy Scale (NGSE)

    Time frame: 6 months: baseline, post intervention (after 3 months), follow-up (after 3 more months)

    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

  3. the Short Form Zarit Burden Interview

    Time frame: 6 months: baseline, post intervention (after 3 months), follow-up (after 3 more months)

    A measure of caregiver burden

Other outcomes

  1. Satisfaction questionnaire

    Time frame: Post intervention

    A measure of the participants' satisfaction with the tele-CO-OP intervention

  2. Background questionnaire

    Time frame: 6 months: baseline, post intervention (after 3 months), follow-up (after 3 more months)

    A questionnaire to document sociodemographic and clinical characteristics

Sponsors and collaborators

Lead sponsor

Hadassah Medical Organization

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Nov 30, 2016
Registry last updated
Feb 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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