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ClinicalTrials.gov ID

NCT05588947

Lead Sponsor

University of CalgaryOTHER

Overall Status

Unknown status

Study Type

Interventional

Phase

Not Applicable

Enrollment

150Estimated

Last Update Posted

Oct 20, 2022Actual

Start Date

Oct 10, 2022Estimated

Primary Completion Date

Nov 10, 2023Estimated

Completion Date

Nov 10, 2023Estimated

Official Title

The Tele-Taking Charge After Stroke (TeleTaCAS) Randomized Controlled Feasibility Trial of Telehealth Take Charge vs Control

Brief Summary

Take Charge is a novel, community-based treatment for stroke developed to harness a person's self-determination. Two prior clinical trials with 572 stroke survivors showed that Take Charge improves quality of life, independence, and social participation up to a year after stroke. Take Charge has also been shown to be overall cost-saving to the health system and is a useful adjunct to standard care after stroke.

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.

Detailed Description

For adults diagnosed with acute stroke who are discharged to community living (non-institutionalized), we wish to evaluate whether delivering two Take Charge sessions by telehealth is (1) acceptable to the population of Southern Alberta, and (2) feasible to do.

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.

• Stroke/Brain Attack

• Take Charge session
• Active Control

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• Discharged with diagnosis of stroke to non-institutionalised community living situation
• 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:

• Major comorbid illness that would dictate functional outcome at 12 months or life expectancy < 12 months
• Pre-stroke dependency (mRS > 2 before index stroke)

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Single

Lead Sponsor

University of CalgaryOTHER

vivian.fu@ucalgary.ca5879687352