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

NCT02977624 | Completed

• 1 other identifier: 0689-15-HMO
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

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. 1.Improving function in activities of daily living, participation in occupations and health related quality of life.
2. 2.Reducing the need for outpatient clinic and rehabilitation services.
3. 3.The intervention achievements will be maintained in 3-month follow-up
4. 4.The Canadian Occupational Performance Measure (COPM)
5. 5.The Performance Quality Rating Scale (PQRS)
6. 6.Mayo-Portland Adaptability Inventory (MPAI-4)
7. 7.The Dysexecutive Questionnaire (DEX)
8. 8.The New General Self-Efficacy Scale (NGSE)
9. 9.The Zarit Caregiver Burden Scale short version

Conditions

Brain Injury, Chronic

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• The Dysexecutive Questionnaire (DEX)

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

• The New General Self-Efficacy Scale (NGSE)

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

• the Short Form Zarit Burden Interview

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

Other Outcomes (2)

• Satisfaction questionnaire

  Post intervention

• Background questionnaire

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

Study Arms (2)

Tele-CO-OP

EXPERIMENTAL

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

Waitlist control

NO INTERVENTION

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

Interventions

The Cognitive Orientation to daily Occupational Performance BEHAVIORAL

Tele-CO-OP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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

You may not qualify if:

• (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.

Sponsors & Collaborators

• Hadassah Medical Organization: lead

MeSH Terms

Conditions

Brain Injury, Chronic

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This exploratory study was a partially randomized controlled trial with a waitlist control crossover design.

Study Record Dates

• First Submitted: November 28, 2016
• First Posted: November 30, 2016
• Study Start: December 1, 2016
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: February 1, 2022

Record last verified: 2022-01