Integrated Telehealth After Stroke Care

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.

Conditions

• Blood Pressure
• Stroke, Ischemic
• Stroke Hemorrhagic

Interventions

BEHAVIORAL

Integrated Telehealth After Stroke Care

• 3 week and 8 week follow up visits with pharmacy through telehealth Patients will provide home blood pressure monitoring kits at discharge for the first three months. The telemonitor that can send blood pressure readings, wirelessly or through telephone, to a secure server where study staff can look at the readings. Any blood pressure readings that are not within normal range will trigger an alert to be sent to study staff who will then follow up with the patient. A trained staff member will show the patient how to use the blood pressure monitor. Patients will be asked to take blood pressure at least 3 days per week and transmit the readings to study staff. Patients will also be asked to wear an activity monitor starting at 4 weeks.

BEHAVIORAL

Usual post-stroke follow-up care

* 1-2 weeks follow up visit with primary care. * 4-6 week and 12 week follow up visit with stroke practitioner * At the end of the study, patients will be asked questions regarding their experience with the telehealth visits, health, medication taking and quality of life

Sponsors & Collaborators

• National Center for Advancing Translational Sciences (NCATS)

  collaborator NIH

• Columbia University

  lead OTHER

Principal Investigators

• Syeda Imama A. Naqvi, MD · Assistant Professor of Neurology at the Columbia University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-10-31

Primary Completion

2025-01-31

Completion

2025-06-30

Countries

• United States

Study Locations