Integrated Telehealth After Stroke Care

Blood Pressure Clinical Trial

— iTASC  

Official title:

Integrated Telehealth After Stroke Care

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05049109
• Other study ID #: AAAT7278
• Secondary ID: KL2TR001874
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: February 1, 2023

Study information

• Verified date: September 2021
• Source: Columbia University
• Contact: Syeda Imama A. Naqvi, MD
• Phone: 212-305-8389
• Email: ian2108[@]cumc.columbia.edu
• Is FDA regulated: No
• 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: February 1, 2023
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• unable to provide informed consent

Related Conditions & MeSH terms

• Blood Pressure
• Hemorrhagic Stroke
• Ischemic Stroke
• Stroke
• Stroke Hemorrhagic
• Stroke, Ischemic

Intervention

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.
• 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

Locations

Country	Name	City	State
United States	CUIMC	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	National Center for Advancing Translational Science (NCATS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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