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

Brain Injury, Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02977624
• Other study ID #: 0689-15-HMO
• Status: Completed
• Phase: N/A
• Start date: December 2016
• Est. completion date: December 2020

Study information

• Verified date: January 2022
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injury, Chronic
• Wounds and Injuries

Intervention

Behavioral:
• The Cognitive Orientation to daily Occupational Performance

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Satisfaction questionnaire	A measure of the participants' satisfaction with the tele-CO-OP intervention	Post intervention
Other	Background questionnaire	A questionnaire to document sociodemographic and clinical characteristics	6 months: baseline, post intervention (after 3 months), follow-up (after 3 more months)
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)