Integrated Telehealth After Stroke Care

NCT05049109 | Withdrawn

• 2 other identifiers: AAAT7278KL2TR001874
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 \<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

Keywords

Post-stroke BP management; BP control

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Group X

EXPERIMENTAL

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; Behavioral: Usual post-stroke follow-up care

Group Y

ACTIVE COMPARATOR

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

Interventions

Integrated Telehealth After Stroke Care BEHAVIORAL

• 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.

Also known as: iTASC

Group X

Usual post-stroke follow-up care BEHAVIORAL

* 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

Also known as: Standard of care practice

Group X; Group Y

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• unable to provide informed consent

Sponsors & Collaborators

• Columbia University: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

CUIMC

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Ischemic Stroke; Hemorrhagic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Syeda Imama A. Naqvi, MD

  Assistant Professor of Neurology at the Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2021
• First Posted: September 17, 2021
• Study Start: October 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: June 1, 2025
• Last Updated: June 12, 2024

Record last verified: 2024-06

Locations

US (1)