Clinical trial NCT02977624: 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
Overall status: COMPLETED
Phase: NA
Conditions: Brain Injury, Chronic
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2016-11-30
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This exploratory study was a partially randomized controlled trial with a waitlist control crossover design.
Primary purpose: TREATMENT

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:

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.

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.

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.

Primary outcomes:
measure: The Canadian Occupational Performance Measure (COPM)
timeFrame: 6 months: baseline, post intervention (after 3 months), follow-up (after 3 more months)
measure: The Performance Quality Rating Scale (PQRS)
timeFrame: 6 months: baseline, post intervention (after 3 months), follow-up (after 3 more months)
measure: The Mayo-Portland Adaptability Inventory (MPAI-4)
timeFrame: 6 months: baseline, post intervention (after 3 months), follow-up (after 3 more months)
Secondary outcomes:
measure: The Dysexecutive Questionnaire (DEX)
timeFrame: 6 months: baseline, post intervention (after 3 months), follow-up (after 3 more months)
measure: The New General Self-Efficacy Scale (NGSE)
timeFrame: 6 months: baseline, post intervention (after 3 months), follow-up (after 3 more months)
measure: the Short Form Zarit Burden Interview
timeFrame: 6 months: baseline, post intervention (after 3 months), follow-up (after 3 more months)
Other outcomes:
measure: Satisfaction questionnaire
timeFrame: Post intervention
measure: Background questionnaire
timeFrame: 6 months: baseline, post intervention (after 3 months), follow-up (after 3 more months)
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