Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT05049109 |
| Other study ID # |
AAAT7278 |
| Secondary ID |
KL2TR001874 |
| Status |
Withdrawn |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 2024 |
| Est. completion date |
June 2025 |
Study information
| Verified date |
June 2024 |
| Source |
Columbia University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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 <140/90 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.
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 patient's
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.
