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

Sponsor
Columbia University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04640519
Collaborator
National Center for Advancing Translational Science (NCATS) (NIH)
50
1
2
10.4
4.8

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Usual care
  • Other: TASC intervention
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention 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)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:
Single (Outcomes Assessor)
Primary Purpose:
Health Services Research
Official Title:
Telehealth After Stroke Care (TASC): Integrated Multidisciplinary Access to Post-stroke Care
Actual Study Start Date :
Oct 20, 2020
Anticipated Primary Completion Date :
Aug 31, 2021
Anticipated Study Completion Date :
Sep 1, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Number of Participants with BP Control [Up to 3 months]

    BP control will be determined by the mean 24-hr blood pressure through remote monitoring at 3 months and survey patient reported outcomes for participants in the TASC intervention arm. Participants randomized to only the standard usual care will receive a one and three month post stroke follow up appointment post-discharge and no 24-hr blood pressure remote monitoring.

Secondary Outcome Measures

  1. Number of participants who completed 5 visits and satisfaction surveys [3 months]

    This measures the feasibility of the TASC model, the interdisciplinary team competency, fidelity of implementation.

  2. Medication adherence percentage [3 months]

    Feasibility as assessed by patient reported outcomes of self-efficacy in medication adherence and treatment before and after

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The Neurological Institute of New York, Columbia University New York New York United States 10032

Sponsors and Collaborators

  • Columbia University
  • National Center for Advancing Translational Science (NCATS)

Investigators

  • Principal Investigator: Imama Naqvi, MD, Columbia University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Imama A. Naqvi, Assistant Professor of Neurology, Columbia University
ClinicalTrials.gov Identifier:
NCT04640519
Other Study ID Numbers:
  • AAAT2612
  • UL1TR001873
First Posted:
Nov 23, 2020
Last Update Posted:
Aug 3, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Imama A. Naqvi, Assistant Professor of Neurology, Columbia University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 3, 2021