Integrated Telehealth After Stroke Care
Withdrawn before enrolling · Not applicable
Conditions studied: Blood Pressure, Stroke, Ischemic, Stroke Hemorrhagic
In brief
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.
Key facts
- Study ID
- NCT05049109
- Run by
- Columbia University
- People needed
- 0
- Starts
- 2024-10-01
- Expected to finish
- 2025-06-01
- Last updated by the study team
- 2024-06-12
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 18 years or older
- have had a stroke and have high blood pressure
You may not qualify if…
- unable to provide informed consent
Where it is running
- CUIMC — New York, New York, United States
Full record on ClinicalTrials.gov
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