Stroke Telemedicine Outpatient Prevention Program for Blood Pressure Reduction (STOP-Stroke)

Stroke Telemedicine Outpatient Program (STOP) for Blood Pressure Reduction

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.

Study Overview

• Status: Completed
• Conditions: Blood Pressure; Telemedicine; Psychosocial Impairment; Stroke Prevention
• Intervention / Treatment: Behavioral: Educational Packet; Behavioral: Phone call at 72 hours by discharge nurse navigator; Behavioral: Telehealth visit at 7 days, 1 month, 3 months, and 5 months after discharge; Behavioral: Educational messages every other week; Diagnostic test: BP monitoring by QardioARM with periodic transmission of BP data

• Study Type: Interventional
• Enrollment (Actual): 83
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • University of Texas Health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Ischemic and hemorrhagic stroke patients
• Presence of at least one of the following high risk criteria: uninsured, Medicaid payer status, small vessel ischemic stroke, hypertensive ICH)
• Age ≥ 18; presence of hypertension (by clinical history or hospital BP ≥140/90 on two occasions)
• Plan to discharge home after stroke
• Ability to provide consent (patient or caregiver)
• Ability to communicate in English

Exclusion Criteria:

• modified Rankin scale > 4 at the time of enrollment (severe disability)
• life expectancy < 1 year or terminal illness,
• eGFR < 30 at time of discharge
• pregnancy
• symptomatic flow limiting carotid stenosis without plan for intervention
• urine toxicology positive for cocaine or methamphetamine or recent use
• long-term BP goal ≥ 130/80 mmHg according to clinical team

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: STOP model; Pharmacist evaluates patient prior to discharge and a nurse navigator contacts patient 72 hours after discharge. Patient receives educational packet and a blue tooth enabled BP monitor with an iPad. A video telehealth visit occurs 7 days after discharge attended by a nurse practitioner (NP) or MD , social worker (SW), and pharmacist. The NP and pharmacist review the BP data to determine the need for medication adjustment. The SW assesses the need for resources. BP is reviewed via an online portal every 2 weeks until average BP is < 130/80mmHg, then monthly. Uncontrolled BP prompts a call from the pharmacist to discuss medication adherence and titration. Subsequent video telehealth visits occur 1 month, 3 months, and 5 months after enrollment.	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.
ACTIVE_COMPARATOR: Usual Care; Pharmacist evaluates patient prior to discharge and a nurse navigator contacts patient 72 hours after discharge. Patient receives educational packet.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Daytime Ambulatory Systolic Blood Pressure	Blood pressure will be assessed with an ambulatory blood pressure monitor (ABPM).	6 months after enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Daytime Ambulatory Diastolic Blood Pressure	Blood pressure will be assessed with an ambulatory blood pressure monitor (ABPM).	6 months
Night Time Ambulatory Systolic Blood Pressure	Blood pressure will be assessed with an ambulatory blood pressure monitor (ABPM).	6 months
Nighttime Diastolic Blood Pressure	Blood pressure will be assessed with an ambulatory blood pressure monitor (ABPM).	6 months
Body Mass Index(BMI)	BMI will be calculated from height and weight.	6 months
Number of Participants With Recurrent Vascular Events (Stroke, Myocardial Infarction, Acute Cardiac Death)	Recurrent vascular events include stroke, myocardial infarction, or acute cardiac death.	6 months
Number of Participants With Acute Healthcare Utilization	Acute healthcare utilization includes hospital readmission and acute care visits to emergency room and/or urgent care.	6 months

Other Outcome Measures

Outcome Measure	Time Frame
Caregiver Burden as Assessed by the Zarit Caregiver Burden Questionnaire	6 months
Medication Adherence as Assessed by the Morisky Medication Adherence Scale (MMAS)	6 months
Self-efficacy for Taking Medication as Prescribed as Assessed by the Medication Adherence Self-Efficacy Scale (MASES)	6 months
Self-efficacy for Taking Medication as Prescribed as Assessed by the Medication Adherence Self-Efficacy Scale (MASES)	Baseline

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: National Center for Advancing Translational Sciences (NCATS)
• Investigators: Principal Investigator: Anjail Sharrief, The University of Texas Health Science Center of Houston

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 4, 2019
• Primary Completion (ACTUAL): October 14, 2021
• Study Completion (ACTUAL): October 14, 2021

Study Registration Dates

• First Submitted: April 18, 2019
• First Submitted That Met QC Criteria: April 18, 2019
• First Posted (ACTUAL): April 23, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 9, 2022
• Last Update Submitted That Met QC Criteria: October 14, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: HSC-MS-18-0925

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes