Clinical trial NCT05588947: The Tele-Taking Charge After Stroke Randomized Controlled Feasibility Trial
Official title: The Tele-Taking Charge After Stroke (TeleTaCAS) Randomized Controlled Feasibility Trial of Telehealth Take Charge vs Control
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke/Brain Attack
Keywords: self-determination
rehabilitation
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2022-10-20
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective Randomized Controlled Open Blinded Endpoint Feasibility Trial
Primary purpose: TREATMENT

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.

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 outcomes:
measure: Rate of recruitment
timeFrame: 12 months
Secondary outcomes:
measure: Eligibility
timeFrame: 12 months
measure: Treatment adherence
timeFrame: 12 months
measure: Acceptability of Tele-TaCAS
timeFrame: 2 weeks after receiving Tele-TaCAS
measure: Health-related quality of life
timeFrame: 6 and 12 months after stroke
measure: Independence - modified Rankin scale 0 to 2
timeFrame: 6 and 12 months after stroke
measure: Activities of Daily Living - Barthel Index
timeFrame: 6 and 12 months after stroke
measure: Instrumental Activities of Daily Living / Social Participation - Frenchay Activities Index
timeFrame: 6 and 12 months after stroke
measure: Quality of Life - EQ5D5L
timeFrame: 6 and 12 months after stroke
measure: Self-Determination - AMP-C
timeFrame: 6 and 12 months after stroke
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Dr Vernon Fanning CareWest Rehabilitation Centre
city: Calgary
country: Canada
facility: Foothills Medical Centre
Study officials:
References: