Brain Injury, ChronicNCT02977624
A Telerehabilitation Intervention to Improve Activity and Participation Among Adults Following Acquired Brain Injury
A study testing The Cognitive Orientation to daily Occupational Performance in people with Brain Injury, Chronic, run by Hadassah Medical Organization.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Injury, Chronic
- What is being tested?
- The Cognitive Orientation to daily Occupational Performance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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
Who cannot join
- 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.
About this study
Official title: Effectiveness of 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:
Read more
- 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.
Read the 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.
- Conditions
- Brain Injury, Chronic
- Being tested
- The Cognitive Orientation to daily Occupational Performance
- Medical subject headings
- Brain Injury, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Cognitive Orientation to daily Occupational PerformanceBehavioural
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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).
Measured: 6 months: baseline, post intervention (after 3 months), follow-up (after 3 more months)
Secondary outcomes (3)
The Dysexecutive Questionnaire (DEX)
The DEX is a 20-item questionnaire to assess executive function in daily life among people with ABI
Measured: 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
Measured: 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
Measured: 6 months: baseline, post intervention (after 3 months), follow-up (after 3 more months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2016 (estimated)
- Study startDec 2016
- Primary completionDec 2020
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Injury, ChronicStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This exploratory study was a partially randomized controlled trial with a waitlist control crossover design.
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02977624
- Sponsor's protocol ID
- 0689-15-HMO
- Status last verified
- Jan 2022
- First submitted
- 28 Nov 2016
- Last updated
- 1 Feb 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Telerehabilitation Intervention to Improve Activity and Participation Among Adults Following Acquired Brain Injury
- ClinicalTrials.gov ID
- NCT02977624
- Acronym / sponsor ID
- 0689-15-HMO
- Conditions
- Brain Injury, Chronic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- Dec 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 30 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This exploratory study was a partially randomized controlled trial with a waitlist control crossover design.
| Arm | Type | Receives |
|---|---|---|
| Tele-CO-OP | Experimental | Behavioral: The Cognitive Orientation to daily Occupational PerformanceThe 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. |
| Waitlist control | No intervention | –The waitlist control group did not receive the intervention during the same time period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ≥ 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The Cognitive Orientation to daily Occupational Performance | Behavioural | Tele-CO-OP |
Primary outcome
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.
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.
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).
3 secondary outcomes
The Dysexecutive Questionnaire (DEX)
Time frame: 6 months: baseline, post intervention (after 3 months), follow-up (after 3 more months)
The New General Self-Efficacy Scale (NGSE)
Time frame: 6 months: baseline, post intervention (after 3 months), follow-up (after 3 more months)
the Short Form Zarit Burden Interview
Time frame: 6 months: baseline, post intervention (after 3 months), follow-up (after 3 more months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing The Cognitive Orientation to daily Occupational Performance in people with Brain Injury, Chronic, run by Hadassah Medical Organization.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Canadian Occupational Performance Measure (COPM) (time frame: 6 months: baseline, post intervention (after 3 months), follow-up (after 3 more months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2022.