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

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

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Hypertension; Health Care Acceptability
• Intervention / Treatment: Other: TASC intervention; Other: Usual care

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • The Neurological Institute of New York, Columbia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 98 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TASC Intervention; 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.	Other: TASC intervention; 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.
Active Comparator: TASC Control; Usual care patients will be seen by a primary care nurse practitioner and a stroke neurologist.	Other: Usual care; Usual care patients will be seen by a primary care nurse practitioner and a stroke neurologist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 3 months
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.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Medication Adherence Percentage	Feasibility as assessed by patient reported outcomes of self-efficacy in bp medication adherence after study intervention.	3 months

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: National Center for Advancing Translational Sciences (NCATS)
• Investigators: Principal Investigator: Imama Naqvi, MD, Columbia University

Publications and helpful links

General Publications

• 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.
• 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 Oct 31. doi: 10.1161/STROKEAHA.122.041020. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2020
• Primary Completion (Actual): July 29, 2021
• Study Completion (Actual): July 29, 2021

Study Registration Dates

• First Submitted: November 17, 2020
• First Submitted That Met QC Criteria: November 17, 2020
• First Posted (Actual): November 23, 2020

Study Record Updates

• Last Update Posted (Actual): October 3, 2022
• Last Update Submitted That Met QC Criteria: September 6, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Telehealth; Blood Pressure (BP)
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: AAAT2612; UL1TR001873 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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