Integrated Telehealth After Stroke Care (iTASC)
Primary Purpose
Blood Pressure, Stroke, Ischemic, Stroke Hemorrhagic
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Integrated Telehealth After Stroke Care
Usual post-stroke follow-up care
Sponsored by
About this trial
This is an interventional prevention trial for Blood Pressure focused on measuring Post-stroke BP management, BP control
Eligibility Criteria
Inclusion Criteria:
- 18 years or older
- have had a stroke and have high blood pressure
Exclusion Criteria:
- unable to provide informed consent
Sites / Locations
- CUIMC
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group X
Group Y
Arm Description
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.
Patients who have had stroke and high blood pressure will participate in 3 visits with primary care and stroke practitioner.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05049109
First Posted
September 3, 2021
Last Updated
September 16, 2021
Sponsor
Columbia University
Collaborators
National Center for Advancing Translational Sciences (NCATS)
1. Study Identification
Unique Protocol Identification Number
NCT05049109
Brief Title
Integrated Telehealth After Stroke Care
Acronym
iTASC
Official Title
Integrated Telehealth After Stroke Care
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2021 (Anticipated)
Primary Completion Date
November 1, 2022 (Anticipated)
Study Completion Date
February 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
Collaborators
National Center for Advancing Translational Sciences (NCATS)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Pressure, Stroke, Ischemic, Stroke Hemorrhagic
Keywords
Post-stroke BP management, BP control
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group X
Arm Type
Experimental
Arm Description
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.
Arm Title
Group Y
Arm Type
Active Comparator
Arm Description
Patients who have had stroke and high blood pressure will participate in 3 visits with primary care and stroke practitioner.
Intervention Type
Behavioral
Intervention Name(s)
Integrated Telehealth After Stroke Care
Other Intervention Name(s)
iTASC
Intervention Description
• 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.
Intervention Type
Behavioral
Intervention Name(s)
Usual post-stroke follow-up care
Other Intervention Name(s)
Standard of care practice
Intervention Description
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
Primary Outcome Measure Information:
Title
Mean 24-hr systolic blood pressure (SBP) through remote monitoring at 3 months
Description
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.
Time Frame
3 Months
Title
Difference in systolic blood pressure (SBP) from baseline to 3 months
Description
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.
Time Frame
Baseline and 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years or older
have had a stroke and have high blood pressure
Exclusion Criteria:
unable to provide informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Syeda Imama A. Naqvi, MD
Phone
212-305-8389
Email
ian2108@cumc.columbia.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Carmen Castillo
Phone
212-305-7755
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Syeda Imama A. Naqvi, MD
Organizational Affiliation
Assistant Professor of Neurology at the Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
CUIMC
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carmen Castillo
Phone
212-305-7755
First Name & Middle Initial & Last Name & Degree
Syeda Imama A. Naqvi, MD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Integrated Telehealth After Stroke Care
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