Ignite Creation Date:
2024-05-06 @ 6:13 PM
Last Modification Date:
2024-10-26 @ 2:44 PM
Study NCT ID:
NCT05588947
Status:
UNKNOWN
Last Update Posted:
2022-10-20
First Post:
2022-10-17
Brief Title:
The Tele-Taking Charge After Stroke Randomized Controlled Feasibility Trial
Sponsor:
University of Calgary
Organization:
University of Calgary
Study Overview
Official Title:
The Tele-Taking Charge After Stroke TeleTaCAS Randomized Controlled Feasibility Trial of Telehealth Take Charge vs Control
Status:
UNKNOWN
Status Verified Date:
2022-10
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TeleTaCAS
Brief Summary:
Take Charge is a novel community-based treatment for stroke developed to harness a persons 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None