The Tele-Taking Charge After Stroke Randomized Controlled Feasibility Trial
TeleTaCAS
1 other identifier
interventional
150
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2022
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 10, 2022
CompletedFirst Submitted
Initial submission to the registry
October 17, 2022
CompletedFirst Posted
Study publicly available on registry
October 20, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 10, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 10, 2023
CompletedOctober 20, 2022
October 1, 2022
1.1 years
October 17, 2022
October 17, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of recruitment
Number of participants recruited per month
12 months
Secondary Outcomes (9)
Eligibility
12 months
Treatment adherence
12 months
Acceptability of Tele-TaCAS
2 weeks after receiving Tele-TaCAS
Health-related quality of life
6 and 12 months after stroke
Independence - modified Rankin scale 0 to 2
6 and 12 months after stroke
- +4 more secondary outcomes
Study Arms (2)
Tele-TaCAS
EXPERIMENTALTwo 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.
Control
ACTIVE COMPARATORLife After Stroke: Survivor Stories video played by telehealth at 2 to 16 weeks after stroke, the earliest possible time after discharge to the community.
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Major comorbid illness that would dictate functional outcome at 12 months or life expectancy \< 12 months
- Pre-stroke dependency (mRS \> 2 before index stroke)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Dr Vernon Fanning CareWest Rehabilitation Centre
Calgary, Canada
Foothills Medical Centre
Calgary, Canada
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
October 17, 2022
First Posted
October 20, 2022
Study Start
October 10, 2022
Primary Completion
November 10, 2023
Study Completion
November 10, 2023
Last Updated
October 20, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share