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

Stroke Clinical Trial

— TASC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04640519
• Other study ID #: AAAT2612
• Secondary ID: UL1TR001873
• Status: Completed
• Phase: N/A
• Start date: October 20, 2020
• Est. completion date: July 29, 2021

Study information

• Verified date: September 2022
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 29, 2021
• Est. primary completion date: July 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Health Care Acceptability
• Hypertension
• Stroke

Intervention

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

Locations

Country	Name	City	State
United States	The Neurological Institute of New York, Columbia University	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	National Center for Advancing Translational Sciences (NCATS)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 multidisciplinar — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Medication Adherence Percentage	Feasibility as assessed by patient reported outcomes of self-efficacy in bp medication adherence after study intervention.	3 months