Stroke/Brain AttackTeleTaCASNCT05588947
The Tele-Taking Charge After Stroke Randomized Controlled Feasibility Trial
A study testing Take Charge session in people with Stroke/Brain Attack, run by University of Calgary at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke/Brain Attack
- What is being tested?
- Take Charge session
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesCanada
- Study dates
- 10 Oct 2022to 10 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Major comorbid illness that would dictate functional outcome at 12 months or life expectancy < 12 months
- Pre-stroke dependency (mRS > 2 before index stroke)
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Dr Vernon Fanning CareWest Rehabilitation Centre
Calgary
Team Leader / Nurse Clinician, 4032306900
Foothills Medical Centre
Calgary
Vivian Fu, PhD, 5879687352, vivian.fu@ucalgary.ca
About this study
Official title: The Tele-Taking Charge After Stroke (TeleTaCAS) Randomized Controlled Feasibility Trial of Telehealth Take Charge vs Control
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.
Read more
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.
Read the 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.
- Conditions
- Stroke/Brain Attack
- Being tested
- Take Charge session, Active Control
- Keywords
- self-determination, rehabilitation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Take Charge sessionOther
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 ControlOther
Life After Stroke educational video
| Study group | Role | What they receive |
|---|---|---|
| Tele-TaCAS | Experimental | 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. Receives: Other: Take Charge session |
| Control | Active comparator | 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. Receives: Other: Active Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of recruitment
Number of participants recruited per month
Measured: 12 months
Secondary outcomes (9)
Eligibility
Number of people meeting eligibility criteria
Measured: 12 months
Treatment adherence
Number receiving both sessions
Measured: 12 months
Acceptability of Tele-TaCAS
Participant acceptability questionnaire
Measured: 2 weeks after receiving Tele-TaCAS
Health-related quality of life
Physical Component Summary score of the Short Form 36
The PCS of the SF-36 is a psychometrically robust measure of health-related quality of life. The score is formed from an algorithm comprising 36 questions that assess functional health and well-being from the perspective of the patient. The items contribute to eight health domains of physical functioning, role limitations due to physical problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems and mental health. The eight domains all contribute to physical component summary (PCS) and mental component summary (MCS) scores. The minimal clinically important difference (MCID) of the PCS in stroke is estimated to be 2.5.
Measured: 6 and 12 months after stroke
Independence - modified Rankin scale 0 to 2
The modified Rankin scale (mRS) is a global disability measure used commonly in acute stroke trials. The scale ranges from 0 to 6. 0 = no symptoms, 1 = able to carry out all usual activities despite symptoms, 2 = able to look after own affairs without assistance but unable to carry out all usual activities, 3 moderate disability, unable to look after own affairs but able to walk without assistance, 4 = unable to attend to own bodily needs or unable to walk without assistance, 5 = severe disability, bedridden, 6 = dead.
Measured: 6 and 12 months after stroke
Activities of Daily Living - Barthel Index
The Barthel Index (BI) measures a person's current ability to do 10 different common activities with or without assistance, including bathing, walking upstairs, toileting, and feeding. The total scores range from 0 to 20, with a higher score representing more independence.
Measured: 6 and 12 months after stroke
Instrumental Activities of Daily Living / Social Participation - Frenchay Activities Index
The Frenchay Activities Index (FAI) is a measure of instrumental activities of daily living that assesses a broad range of activities associated with everyday life that a patient has participated in within the recent past. These can be separated into three domains: domestic chores, leisure/work, and outdoor activities. The patient self-reports how frequently each activity was done in the prior 3-6 months, and the total score can range from 0 to 45. The higher the score, the more social participation has been reported.
Measured: 6 and 12 months after stroke
Quality of Life - EQ5D5L
European Quality of Life 5 Dimension 5 Levels (EQ-5D-5L) is a self-reported measure of global quality of life in five domains and at five levels. There is also a visual analogue scale from 0 - 100 to self-rate how healthy a person feels that particular day.
Measured: 6 and 12 months after stroke
Self-Determination - AMP-C
An Autonomy Mastery Purpose Connectedness score derived by our group with four statements and self-reported level of agreement on a Likert scale. Not validated but measured in the last Take Charge trial.
Measured: 6 and 12 months after stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2022
- Study start10 Oct 2022 (estimated)
- Primary completion10 Nov 2023 (estimated)
- Study completion10 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke/Brain AttackStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective Randomized Controlled Open Blinded Endpoint Feasibility Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Sean Dukelow, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05588947
- Sponsor's protocol ID
- Version 1.0 25Sept2022
- Acronym
- TeleTaCAS
- Status last verified
- Oct 2022
- First submitted
- 17 Oct 2022
- Last updated
- 20 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Tele-Taking Charge After Stroke (TeleTaCAS) Randomized Controlled Feasibility Trial of Telehealth Take Charge vs Control
- ClinicalTrials.gov ID
- NCT05588947
- Acronym / sponsor ID
- TeleTaCAS / Version 1.0 25Sept2022
- Conditions
- Stroke/Brain Attack
- Keywords
- self-determination, rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 10 Oct 2022 (estimated)
- Primary completion
- 10 Nov 2023 (estimated)
- Study completion
- 10 Nov 2023 (estimated)
- First posted
- 20 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective Randomized Controlled Open Blinded Endpoint Feasibility Trial
| Arm | Type | Receives |
|---|---|---|
| Tele-TaCAS | Experimental | Other: Take Charge sessionTwo 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 comparator | Other: Active ControlLife After Stroke: Survivor Stories video played by telehealth at 2 to 16 weeks after stroke, the earliest possible time after discharge to the community. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Major comorbid illness that would dictate functional outcome at 12 months or life expectancy < 12 months
- Pre-stroke dependency (mRS > 2 before index stroke)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Take Charge sessionA '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 | Tele-TaCAS |
| Active ControlLife After Stroke educational video | Other | Control |
Primary outcome
Rate of recruitment
Time frame: 12 months
Number of participants recruited per month
9 secondary outcomes
Eligibility
Time frame: 12 months
Treatment adherence
Time frame: 12 months
Acceptability of Tele-TaCAS
Time frame: 2 weeks after receiving Tele-TaCAS
Health-related quality of life
Time frame: 6 and 12 months after stroke
Independence - modified Rankin scale 0 to 2
Time frame: 6 and 12 months after stroke
Activities of Daily Living - Barthel Index
Time frame: 6 and 12 months after stroke
Instrumental Activities of Daily Living / Social Participation - Frenchay Activities Index
Time frame: 6 and 12 months after stroke
Quality of Life - EQ5D5L
Time frame: 6 and 12 months after stroke
Self-Determination - AMP-C
Time frame: 6 and 12 months after stroke
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2022.
- Taking Charge After Stroke main results paperLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Take Charge session in people with Stroke/Brain Attack, run by University of Calgary at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vivian WY Fu, PhD (5879687352, vivian.fu@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of recruitment (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2022.