The Tele-Taking Charge After Stroke Randomized Controlled Feasibility Trial
NCT ID: NCT05588947
Last Updated: 2022-10-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
150 participants
INTERVENTIONAL
2022-10-10
2023-11-10
Brief Summary
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Because of the COVID-19 pandemic, a lot of healthcare has moved into a telehealth approach. The simplicity of Take Charge may lend itself to being effective if delivered by telehealth, allowing greater access for people with stroke in rural communities. Improving the care we provide in underserved regions of the country is important to help the health of Canadians.
We are proposing a new study, working closely with the researchers who ran the previous Take Charge studies.
The goal of this feasibility clinical trial is to learn about Tele-Take Charge in adults with stroke who live in Southern Alberta. The main questions it aims to answer are:
* is delivering Take Charge by telehealth feasible?
* is Take Charge by telehealth acceptable to this population?
Participants will meet with facilitators online via Zoom at 4 to 16 weeks after stroke, and be randomized to receive either:
* two Tele-Take Charge sessions six weeks apart
* one control tele-education session.
Researchers will compare the Tele-Take Charge and control groups to see if there are any differences in outcome measures. these differences will help researchers to estimate the number of participants that will be needed for a larger, multi-centred effectiveness trial.
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Detailed Description
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Subjects will be randomly assigned to receive either two Tele-Take Charge sessions or one tele-education session (Life After Stroke video) by telehealth (the active control).
The primary feasibility outcome will be recruitment rate. Secondary outcomes will be measured by a blinded outcomes assessor at 6 and 12 months, either by e-questionnaire or by telephone.
Those who received Tele-Take Charge will also be asked to complete an acceptability questionnaire, and will be invited to take part in an in-depth interview about their experience as part of a qualitative substudy.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Tele-TaCAS
Two Take Charge sessions delivered by telehealth six weeks apart, the first being at 2 to 16 weeks after stroke, the earliest possible time after discharge to the community.
Take Charge session
A 'talk therapy' session designed to harness the person's self-determination, re-establishing purpose, identity, autonomy, and skills to Take Charge of their recovery after stroke
Control
Life After Stroke: Survivor Stories video played by telehealth at 2 to 16 weeks after stroke, the earliest possible time after discharge to the community.
Active Control
Life After Stroke educational video
Interventions
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Take Charge session
A 'talk therapy' session designed to harness the person's self-determination, re-establishing purpose, identity, autonomy, and skills to Take Charge of their recovery after stroke
Active Control
Life After Stroke educational video
Eligibility Criteria
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Inclusion Criteria
* Answering 'No' to the question 'Are you fully recovered from your stroke?' (i.e., modified Rankin score \[mRS\] must be \> 0)
* Able to access video calling with a smartphone, computer, or other device
Exclusion Criteria
* Pre-stroke dependency (mRS \> 2 before index stroke)
18 Years
ALL
No
Sponsors
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University of Calgary
OTHER
Responsible Party
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Dr. Sean Dukelow
Associate Professor
Locations
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Dr Vernon Fanning CareWest Rehabilitation Centre
Calgary, , Canada
Foothills Medical Centre
Calgary, , Canada
Countries
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Central Contacts
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Facility Contacts
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Team Leader / Nurse Clinician
Role: primary
Related Links
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Taking Charge After Stroke main results paper
Other Identifiers
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Version 1.0 25Sept2022
Identifier Type: -
Identifier Source: org_study_id
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