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

NCT04640519 | Completed Results

• 2 other identifiers: AAAT2612UL1TR001873
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke; Health Care Acceptability; Hypertension

Keywords

Telehealth; Blood Pressure (BP)

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Medication Adherence Percentage

  3 months

Study Arms (2)

TASC Intervention

EXPERIMENTAL

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 Control

ACTIVE COMPARATOR

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

Other: Usual care

Interventions

Usual care OTHER

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

TASC Control

TASC intervention OTHER

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.

TASC Intervention

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

The Neurological Institute of New York, Columbia University

New York, New York, 10032, United States

Location

Related Publications (2)

• 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.

  PMID: 35410312 RESULT

• 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.

  PMID: 36314123 DERIVED

MeSH Terms

Conditions

Stroke; Patient Acceptance of Health Care; Hypertension

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior

Results Point of Contact

• Title: Imama Naqvi, MD
• Organization: Columbia University

ian2108@cumc.columbia.edu

646-426-3876

Study Officials

• Imama Naqvi, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Neurology

Model Details: 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)

Study Record Dates

• First Submitted: November 17, 2020
• First Posted: November 23, 2020
• Study Start: October 20, 2020
• Primary Completion: July 29, 2021
• Study Completion: July 29, 2021
• Last Updated: October 3, 2022
• Results First Posted: October 3, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)