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Telehealth After Stroke Care: Integrated Multidisciplinary Access to Post-stroke Care (TASC)

Primary Purpose

Stroke, Health Care Acceptability, Hypertension

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Usual care
TASC intervention
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Stroke focused on measuring Telehealth, Blood Pressure (BP)

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Presence of hypertension (by clinical history or hospital BP ≥140/90 on two occasions)
  • Plan for discharge home after stroke
  • Ability to provide consent (patient or caregiver)

Exclusion Criteria:

  • Modified Rankin scale ≥ 4 at time of enrollment (severely disabled)
  • Pregnancy
  • Severe psychiatric illness
  • Dialysis or diagnosis of end stage renal disease
  • Life expectancy < 1 year or terminal illness
  • Symptomatic flow limiting cerebrovascular stenosis without plan for intervention, or long-term BP goal ≥ 140/90

Sites / Locations

  • The Neurological Institute of New York, Columbia University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TASC Intervention

TASC Control

Arm Description

TASC patients will receive a BP monitoring kit and electronic tablet and tailored infographics, and attend 5 telehealth visits over 3 months, including primary care nurse practitioner, pharmacy and stroke neurologist.

Usual care patients will be seen by a primary care nurse practitioner and a stroke neurologist.

Outcomes

Primary Outcome Measures

Percentage of Participants With Systolic BP Control
The outcome of BP control will be defined by change in mean awake systolic blood pressure from baseline at the time of discharge through remote monitoring at 3 months to be < 130 mmHg. BP control will be determined by the mean 24-hr blood pressure through remote monitoring at 3 months and survey patient reported outcomes for all participants.
Percentage of Participants Who Completed at Least 1 Video Visit
This measures the feasibility of the TASC model, the interdisciplinary team competency, fidelity of implementation.

Secondary Outcome Measures

Medication Adherence Percentage
Feasibility as assessed by patient reported outcomes of self-efficacy in bp medication adherence after study intervention.

Full Information

First Posted
November 17, 2020
Last Updated
September 6, 2022
Sponsor
Columbia University
Collaborators
National Center for Advancing Translational Sciences (NCATS)
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1. Study Identification

Unique Protocol Identification Number
NCT04640519
Brief Title
Telehealth After Stroke Care: Integrated Multidisciplinary Access to Post-stroke Care
Acronym
TASC
Official Title
Telehealth After Stroke Care (TASC): Integrated Multidisciplinary Access to Post-stroke Care
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
October 20, 2020 (Actual)
Primary Completion Date
July 29, 2021 (Actual)
Study Completion Date
July 29, 2021 (Actual)

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
The Telehealth After Stroke Care (TASC) trial is a pilot randomized controlled trial. It aims to evaluate the feasibility of a telehealth based model providing multidisciplinary access including nursing, pharmacy and physician care, and obtain preliminary evidence of efficacy of an integrated telehealth approach to blood pressure management after stroke.
Detailed Description
Hypertension is the most modifiable risk factor for recurrent stroke. Blood pressure (BP) reduction is associated with decreased risk of stroke recurrence but remains poorly controlled in most survivors. Minority groups have a higher prevalence of uncontrolled BP and higher rates of stroke. Limited access contributes to challenges in post-stroke care. Telehealth After Stroke Care (TASC) will be a telehealth intervention that integrates remote BP monitoring and telehealth visits to enhance BP control and promote self-efficacy, with a multidisciplinary approach to improve clinical processes and health outcomes. The investigators will assess for feasibility and obtain preliminary evidence of efficacy. Fifty (50) eligible patients will be screened for inclusion prior to hospital discharge and randomized to TASC or usual care. TASC patients will receive a BP monitoring kit and electronic tablet. They will be scheduled with 5 telehealth visits over 3 months, including primary care nurse practitioner, pharmacy at 4 and 8 weeks and stroke neurologist. Usual care patients will be seen by a primary care nurse practitioner at 1-2 weeks and a stroke neurologist at 1 and 3 months. Data will be collected at 0 and 3 months. The primary outcome will be BP control (BP <140/90 mmHg) at 3 months. The secondary outcome will be self-efficacy in medication adherence and treatment. Interdisciplinary team competency, fidelity, and telehealth satisfaction surveys will be administered. Patient reported outcomes including depression, cognitive function, and socioeconomic determinants will also be collected. Integrated team-based interventions are needed to improve BP control and reduce racial disparities in post-stroke care. It may be feasible and effective in enhancing post-stroke BP control and promoting self-efficacy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Health Care Acceptability, Hypertension
Keywords
Telehealth, Blood Pressure (BP)

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Multidisciplinary Team Nursing: transitions of care, motivational interview w/ tailored infographics Pharmacy: medication education, adherence and titration Physician: patient tailored risk factor control, post stroke complications Integrated Approach: Home BP monitoring with remote support, Telehealth visits by each discipline, Tailored BP infographics, Patient Reported Outcomes (PROs)
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TASC Intervention
Arm Type
Experimental
Arm Description
TASC patients will receive a BP monitoring kit and electronic tablet and tailored infographics, and attend 5 telehealth visits over 3 months, including primary care nurse practitioner, pharmacy and stroke neurologist.
Arm Title
TASC Control
Arm Type
Active Comparator
Arm Description
Usual care patients will be seen by a primary care nurse practitioner and a stroke neurologist.
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
Usual care patients will be seen by a primary care nurse practitioner and a stroke neurologist.
Intervention Type
Other
Intervention Name(s)
TASC intervention
Intervention Description
TASC patients will receive a BP monitoring kit and electronic tablet with patient tailored BP infographics. They will be scheduled with 5 telehealth visits over 3 months, including primary care nurse practitioner, pharmacy and stroke neurologist.
Primary Outcome Measure Information:
Title
Percentage of Participants With Systolic BP Control
Description
The outcome of BP control will be defined by change in mean awake systolic blood pressure from baseline at the time of discharge through remote monitoring at 3 months to be < 130 mmHg. BP control will be determined by the mean 24-hr blood pressure through remote monitoring at 3 months and survey patient reported outcomes for all participants.
Time Frame
Up to 3 months
Title
Percentage of Participants Who Completed at Least 1 Video Visit
Description
This measures the feasibility of the TASC model, the interdisciplinary team competency, fidelity of implementation.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Medication Adherence Percentage
Description
Feasibility as assessed by patient reported outcomes of self-efficacy in bp medication adherence after study intervention.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Presence of hypertension (by clinical history or hospital BP ≥140/90 on two occasions) Plan for discharge home after stroke Ability to provide consent (patient or caregiver) Exclusion Criteria: Modified Rankin scale ≥ 4 at time of enrollment (severely disabled) Pregnancy Severe psychiatric illness Dialysis or diagnosis of end stage renal disease Life expectancy < 1 year or terminal illness Symptomatic flow limiting cerebrovascular stenosis without plan for intervention, or long-term BP goal ≥ 140/90
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Imama Naqvi, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Neurological Institute of New York, Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35410312
Citation
Naqvi IA, Cheung YK, Strobino K, Li H, Tom SE, Husaini Z, Williams OA, Marshall RS, Arcia A, Kronish IM, Elkind MSV. TASC (Telehealth After Stroke Care): a study protocol for a randomized controlled feasibility trial of telehealth-enabled multidisciplinary stroke care in an underserved urban setting. Pilot Feasibility Stud. 2022 Apr 11;8(1):81. doi: 10.1186/s40814-022-01025-z.
Results Reference
result
PubMed Identifier
36314123
Citation
Naqvi IA, Strobino K, Kuen Cheung Y, Li H, Schmitt K, Ferrara S, Tom SE, Arcia A, Williams OA, Kronish IM, Elkind MSV. Telehealth After Stroke Care Pilot Randomized Trial of Home Blood Pressure Telemonitoring in an Underserved Setting. Stroke. 2022 Dec;53(12):3538-3547. doi: 10.1161/STROKEAHA.122.041020. Epub 2022 Oct 31.
Results Reference
derived

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Telehealth After Stroke Care: Integrated Multidisciplinary Access to Post-stroke Care

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