Stroke Telemedicine Outpatient Prevention Program for Blood Pressure Reduction

NCT03923790 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 83

Last updated 2022-11-09

Study results available
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Summary

The purpose of this pilot trial is to compare post-stroke care blood pressure (BP) treatment using an interdisciplinary telehealth model \[called the Stroke Telemedicine Outpatient Program (STOP) for Blood Pressure Reduction\] to usual care in stroke patients at risk for uncontrolled BP. The intervention will address general and stroke-related factors associated with racial disparities in BP control. We will assess feasibility of implementation of the trial and will use the measures and outcomes assessed in the pilot to examine knowledge gaps.

Conditions

  • Stroke Prevention
  • Blood Pressure
  • Telemedicine
  • Psychosocial Impairment

Interventions

BEHAVIORAL

Educational Packet

The patient will receive an educational packet.

BEHAVIORAL

Phone call at 72 hours by discharge nurse navigator

Patients will receive a phone call at 72 hours by the discharge nurse navigator (standard of care) to assure that they have received their medications and follow-up appointments

BEHAVIORAL

Telehealth visit at 7 days, 1 month, 3 months, and 5 months after discharge

A stroke prevention trained nurse practitioner or MD or social worker will review the participant's hospital records and depression, dietary, and sleep apnea screens,will reinforce the care plan based on patient-specific needs.They will counsel patients on salt reduction, the Mediterranean diet, and the importance of diet and exercise for stroke prevention.Along with the pharmacist they will also review the BP data to determine the need for medication adjustment and will discuss the side effects and interactions.The social worker will assess the need for medication assistance and other resources. The care plan will be shared with primary care providers (PCP)and patients will be referred to a PCP if they do not have one. The social worker will also will assist uninsured patients in applying for Texas County Indigent Care programs.

BEHAVIORAL

Educational messages every other week

The messages will be sent to the participants cellular phones and will contain one of the following: a reminder to monitor BP, information from about lifestyle and diet for BP reduction, or a message from the pharmacist about medication adherence

DIAGNOSTIC_TEST

BP monitoring by QardioARM with periodic transmission of BP data

Participants will be prompted to transmit BP logs through the telemonitoring device every 2 weeks until average BP is \< 130/80, then monthly thereafter. Uncontrolled BP will prompt a call from the pharmacist to discuss medication adherence and the need for further titration.

Sponsors & Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

    collaborator NIH
  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Anjail Sharrief · The University Of Texas Health Science Center of Houston

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-04
Primary Completion
2021-10-14
Completion
2021-10-14
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03923790 on ClinicalTrials.gov