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The Tele-Taking Charge After Stroke Randomized Controlled Feasibility Trial

NCT05588947 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2022-10-20

No results posted yet for this study

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.

Conditions

  • Stroke/Brain Attack

Interventions

OTHER

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

OTHER

Active Control

Life After Stroke educational video

Sponsors & Collaborators

  • University of Calgary

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-10-10
Primary Completion
2023-11-10
Completion
2023-11-10

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05588947 on ClinicalTrials.gov