Ignite Creation Date:
2024-05-06 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 2:13 PM
Study NCT ID:
NCT05049109
Status:
WITHDRAWN
Last Update Posted:
2024-06-12
First Post:
2021-09-03
Brief Title:
Integrated Telehealth After Stroke Care
Sponsor:
Columbia University
Organization:
Columbia University
Study Overview
Official Title:
Integrated Telehealth After Stroke Care
Status:
WITHDRAWN
Status Verified Date:
2024-06
Last Known Status:
Not yet recruiting
Delayed Posting:
No
If Stopped, Why?:
No funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
iTASC
Brief Summary:
In this pilot trial the investigator will compare early post-stroke BP management using an integrated Telehealth After Stroke Care iTASC to usual care with a primary outcome of BP control defined by the mean 24-hr blood pressure through remote monitoring at 3 months and survey patient reported outcomes
As this is a preliminary trial with a small sample estimates derived will be used to plan the subsequent larger confirmatory trial Descriptive statistics will characterize the randomized patients completing surveys and outcome assessments The study will evaluate the primary clinical outcome BP 14090 mmHg 90 days post-discharge as a function of treatment and adjusted for from baseline BP Change from baseline BP will also be assessed as an outcome Change in activity level and duration as well as trends in sedentary time will be compared between arms and pre- and post-intervention with visual tailored infographics in the intervention arm Moderating effects of demographics will also be evaluated Decisions regarding the pursuit of a subsequent trial will use the primary outcome and analysis of all other measures will be hypothesis generating
As this is a preliminary trial with a small sample estimates derived will be used to plan the subsequent larger confirmatory trial Descriptive statistics will characterize the randomized patients completing surveys and outcome assessments The study will evaluate the primary clinical outcome BP 14090 mmHg 90 days post-discharge as a function of treatment and adjusted for from baseline BP Change from baseline BP will also be assessed as an outcome Change in activity level and duration as well as trends in sedentary time will be compared between arms and pre- and post-intervention with visual tailored infographics in the intervention arm Moderating effects of demographics will also be evaluated Decisions regarding the pursuit of a subsequent trial will use the primary outcome and analysis of all other measures will be hypothesis generating
Detailed Description:
Hypertension is the single most modifiable risk factor for prevention of secondary stroke However blood pressure BP remains poorly controlled after a stroke in up to 55 of survivors Uncontrolled hypertension is associated with lack of support low level of independence poor medication adherence and limited self-efficacy These barriers are compounded following stroke with limited access to outpatient care Sedentary behavior prevalence after stroke is high in both inpatient and community settings Addressing physical activity may be a simple strategy to help counter growing health concerns during the pandemic from social restrictions
Pre-COVID the investigator created TASC Telehealth After Stroke Care an interdisciplinary telehealth clinic inclusive of primary care pharmacy and stroke specialists to address complex post-acute transitions of care and improve BP control However BP monitoring alone at best has a modest impact on medication adherence and health behaviors As telehealth services expand during the pandemic there is greater incentivization to devise interventions that utilize remote care to foster effective self-management
Improving health behaviors through remote monitoring and patient tailored feedback in an integrated post-acute stroke care model has not been studied Integrated TASC iTASC is a telehealth intervention inclusive of interdisciplinary care and remote technology including BP monitoring and tracked activity supplemented by infographics tailored with the patients own data to enhance BP control and drive health behavior modification
In this proof-of-concept trial the investigator will compare early post-stroke BP management among post-acute stroke patients at discharge randomized to the iTASC intervention or usual care primary care and stroke physician follow up without remote monitoring with a primary outcome of BP control defined by the mean 24-hr BP at 3 months
Pre-COVID the investigator created TASC Telehealth After Stroke Care an interdisciplinary telehealth clinic inclusive of primary care pharmacy and stroke specialists to address complex post-acute transitions of care and improve BP control However BP monitoring alone at best has a modest impact on medication adherence and health behaviors As telehealth services expand during the pandemic there is greater incentivization to devise interventions that utilize remote care to foster effective self-management
Improving health behaviors through remote monitoring and patient tailored feedback in an integrated post-acute stroke care model has not been studied Integrated TASC iTASC is a telehealth intervention inclusive of interdisciplinary care and remote technology including BP monitoring and tracked activity supplemented by infographics tailored with the patients own data to enhance BP control and drive health behavior modification
In this proof-of-concept trial the investigator will compare early post-stroke BP management among post-acute stroke patients at discharge randomized to the iTASC intervention or usual care primary care and stroke physician follow up without remote monitoring with a primary outcome of BP control defined by the mean 24-hr BP at 3 months
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| KL2TR001874 | NIH | None | httpsreporternihgovquickSearchKL2TR001874 |