Integrated Telehealth After Stroke Care (iTASC)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Blood Pressure; Stroke, Ischemic; Stroke Hemorrhagic
• Intervention / Treatment: Behavioral: Integrated Telehealth After Stroke Care; Behavioral: Usual post-stroke follow-up care

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 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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Syeda Imama A. Naqvi, MD; Phone Number: 212-305-8389; Email: ian2108@cumc.columbia.edu
• Study Contact Backup: Name: Carmen Castillo; Phone Number: 212-305-7755

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • CUIMC
      • Contact: Carmen Castillo; Phone Number: 212-305-7755
      • Principal Investigator: Syeda Imama A. Naqvi, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18 years or older
• have had a stroke and have high blood pressure

Exclusion Criteria:

• unable to provide informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group X; Patients who have had stroke and high blood pressure will participate in 5 telehealth visits, which will take place over 3 months. In addition, remote BP monitoring will be given.	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.; Other Names: iTASC; 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; Other Names: Standard of care practice
Active Comparator: Group Y; Patients who have had stroke and high blood pressure will participate in 3 visits with primary care and stroke practitioner.	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; Other Names: Standard of care practice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean 24-hr systolic blood pressure (SBP) through remote monitoring at 3 months	A home blood pressure telemonitor will send blood pressure readings, wirelessly or through telephone, to a secure server where study staff can look at the readings. Patients will be asked to take blood pressure at least 3 days per week. The readings will be averaged to obtain the mean measurement.	3 Months
Difference in systolic blood pressure (SBP) from baseline to 3 months	A home blood pressure telemonitor will send blood pressure readings, wirelessly or through telephone, to a secure server where study staff can look at the readings. This is designed to measure the change in SBP from baseline to 3 months.	Baseline and 3 months

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: National Center for Advancing Translational Sciences (NCATS)
• Investigators: Principal Investigator: Syeda Imama A. Naqvi, MD, Assistant Professor of Neurology at the Columbia University

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2021
• Primary Completion (Anticipated): November 1, 2022
• Study Completion (Anticipated): February 1, 2023

Study Registration Dates

• First Submitted: September 3, 2021
• First Submitted That Met QC Criteria: September 16, 2021
• First Posted (Actual): September 17, 2021

Study Record Updates

• Last Update Posted (Actual): September 17, 2021
• Last Update Submitted That Met QC Criteria: September 16, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Post-stroke BP management; BP control
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Ischemic Stroke; Hemorrhagic Stroke
• Other Study ID Numbers: AAAT7278; KL2TR001874 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No