Clinical trial NCT04640519: Telehealth After Stroke Care: Integrated Multidisciplinary Access to Post-stroke Care
Official title: Telehealth After Stroke Care (TASC): Integrated Multidisciplinary Access to Post-stroke Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Health Care Acceptability
Hypertension
Keywords: Telehealth
Blood Pressure (BP)
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2020-11-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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)
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Percentage of Participants With Systolic BP Control
timeFrame: Up to 3 months
measure: Percentage of Participants Who Completed at Least 1 Video Visit
timeFrame: 3 months
Secondary outcomes:
measure: Medication Adherence Percentage
timeFrame: 3 months
Other outcomes:
Locations:
city: New York
country: United States
facility: The Neurological Institute of New York, Columbia University
state: New York
Study officials:
affiliation: Columbia University
name: Imama Naqvi, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.