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Completed

NCT Number: NCT03923790

Stroke Telemedicine Outpatient Prevention Program 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.

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Key information

Conditions

Stroke Prevention Blood Pressure Psychosocial Impairment Telemedicine

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Educational Packet

Behavioral

The patient will receive an educational packet.

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

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.

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

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.

Primary outcomes

  1. Daytime Ambulatory Systolic Blood Pressure

    Time frame: 6 months after enrollment

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

Secondary outcomes

  1. Daytime Ambulatory Diastolic Blood Pressure

    Time frame: 6 months

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

  2. Night Time Ambulatory Systolic Blood Pressure

    Time frame: 6 months

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

  3. Nighttime Diastolic Blood Pressure

    Time frame: 6 months

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

  4. Body Mass Index(BMI)

    Time frame: 6 months

    BMI will be calculated from height and weight.

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

    Time frame: 6 months

    Recurrent vascular events include stroke, myocardial infarction, or acute cardiac death.

  6. Number of Participants With Acute Healthcare Utilization

    Time frame: 6 months

    Acute healthcare utilization includes hospital readmission and acute care visits to emergency room and/or urgent care.

Other outcomes

  1. Caregiver Burden as Assessed by the Zarit Caregiver Burden Questionnaire

    Time frame: 6 months

  2. Medication Adherence as Assessed by the Morisky Medication Adherence Scale (MMAS)

    Time frame: 6 months

  3. Self-efficacy for Taking Medication as Prescribed as Assessed by the Medication Adherence Self-Efficacy Scale (MASES)

    Time frame: 6 months

  4. Self-efficacy for Taking Medication as Prescribed as Assessed by the Medication Adherence Self-Efficacy Scale (MASES)

    Time frame: Baseline

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)

Registry information

Official study title

Stroke Telemedicine Outpatient Program (STOP) for Blood Pressure Reduction

Acronym: STOP-Stroke

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Apr 23, 2019
Registry last updated
Nov 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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