Stroke Telemedicine Outpatient Prevention Program for Blood Pressure Reduction

NCT03923790 | Completed Results FDA Device

• 1 other identifier: HSC-MS-18-0925
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Daytime Ambulatory Systolic Blood Pressure

  Blood pressure will be assessed with an ambulatory blood pressure monitor (ABPM).

  6 months after enrollment

Secondary Outcomes (6)

• Daytime Ambulatory Diastolic Blood Pressure

  6 months

• Night Time Ambulatory Systolic Blood Pressure

  6 months

• Nighttime Diastolic Blood Pressure

  6 months

• Body Mass Index(BMI)

  6 months

• Number of Participants With Recurrent Vascular Events (Stroke, Myocardial Infarction, Acute Cardiac Death)

  6 months

Other Outcomes (4)

• 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

Study Arms (2)

STOP model

EXPERIMENTAL

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; 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

Usual Care

ACTIVE COMPARATOR

Pharmacist evaluates patient prior to discharge and a nurse navigator contacts patient 72 hours after discharge. Patient receives educational packet.

Behavioral: Educational Packet; Behavioral: Phone call at 72 hours by discharge nurse navigator

Interventions

Educational Packet BEHAVIORAL

The patient will receive an educational packet.

STOP model; Usual Care

Phone call at 72 hours by discharge nurse navigator BEHAVIORAL

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

STOP model; Usual Care

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

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.

STOP model

Educational messages every other week BEHAVIORAL

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

STOP model

BP monitoring by QardioARM with periodic transmission of BP data DIAGNOSTIC_TEST

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.

STOP model

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Results Point of Contact

• Title: Anjail Sharrief, MD, MPH, Associate Professor
• Organization: The University of Texas Health Science Center at Houston

anjail.z.sharrief@uth.tmc.edu

713-500-6538

Study Officials

• Anjail Sharrief

  The University Of Texas Health Science Center of Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 18, 2019
• First Posted: April 23, 2019
• Study Start: March 4, 2019
• Primary Completion: October 14, 2021
• Study Completion: October 14, 2021
• Last Updated: November 9, 2022
• Results First Posted: November 9, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)