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

Primary Purpose

Stroke Prevention, Blood Pressure, Telemedicine

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Educational Packet
Phone call at 72 hours by discharge nurse navigator
Telehealth visit at 7 days, 1 month, 3 months, and 5 months after discharge
Educational messages every other week
BP monitoring by QardioARM with periodic transmission of BP data
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke Prevention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Texas Health Science Center at Houston

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

STOP model

Usual Care

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Daytime Ambulatory Systolic Blood Pressure
Blood pressure will be assessed with an ambulatory blood pressure monitor (ABPM).

Secondary Outcome Measures

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

Full Information

First Posted
April 18, 2019
Last Updated
October 14, 2022
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
National Center for Advancing Translational Sciences (NCATS)
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1. Study Identification

Unique Protocol Identification Number
NCT03923790
Brief Title
Stroke Telemedicine Outpatient Prevention Program for Blood Pressure Reduction
Acronym
STOP-Stroke
Official Title
Stroke Telemedicine Outpatient Program (STOP) for Blood Pressure Reduction
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
March 4, 2019 (Actual)
Primary Completion Date
October 14, 2021 (Actual)
Study Completion Date
October 14, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
National Center for Advancing Translational Sciences (NCATS)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke Prevention, Blood Pressure, Telemedicine, Psychosocial Impairment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
83 (Actual)

8. Arms, Groups, and Interventions

Arm Title
STOP model
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
Pharmacist evaluates patient prior to discharge and a nurse navigator contacts patient 72 hours after discharge. Patient receives educational packet.
Intervention Type
Behavioral
Intervention Name(s)
Educational Packet
Intervention Description
The patient will receive an educational packet.
Intervention Type
Behavioral
Intervention Name(s)
Phone call at 72 hours by discharge nurse navigator
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Telehealth visit at 7 days, 1 month, 3 months, and 5 months after discharge
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Educational messages every other week
Intervention Description
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
Intervention Type
Diagnostic Test
Intervention Name(s)
BP monitoring by QardioARM with periodic transmission of BP data
Intervention Description
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 Outcome Measure Information:
Title
Daytime Ambulatory Systolic Blood Pressure
Description
Blood pressure will be assessed with an ambulatory blood pressure monitor (ABPM).
Time Frame
6 months after enrollment
Secondary Outcome Measure Information:
Title
Daytime Ambulatory Diastolic Blood Pressure
Description
Blood pressure will be assessed with an ambulatory blood pressure monitor (ABPM).
Time Frame
6 months
Title
Night Time Ambulatory Systolic Blood Pressure
Description
Blood pressure will be assessed with an ambulatory blood pressure monitor (ABPM).
Time Frame
6 months
Title
Nighttime Diastolic Blood Pressure
Description
Blood pressure will be assessed with an ambulatory blood pressure monitor (ABPM).
Time Frame
6 months
Title
Body Mass Index(BMI)
Description
BMI will be calculated from height and weight.
Time Frame
6 months
Title
Number of Participants With Recurrent Vascular Events (Stroke, Myocardial Infarction, Acute Cardiac Death)
Description
Recurrent vascular events include stroke, myocardial infarction, or acute cardiac death.
Time Frame
6 months
Title
Number of Participants With Acute Healthcare Utilization
Description
Acute healthcare utilization includes hospital readmission and acute care visits to emergency room and/or urgent care.
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Caregiver Burden as Assessed by the Zarit Caregiver Burden Questionnaire
Time Frame
6 months
Title
Medication Adherence as Assessed by the Morisky Medication Adherence Scale (MMAS)
Time Frame
6 months
Title
Self-efficacy for Taking Medication as Prescribed as Assessed by the Medication Adherence Self-Efficacy Scale (MASES)
Time Frame
6 months
Title
Self-efficacy for Taking Medication as Prescribed as Assessed by the Medication Adherence Self-Efficacy Scale (MASES)
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anjail Sharrief
Organizational Affiliation
The University Of Texas Health Science Center of Houston
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Stroke Telemedicine Outpatient Prevention Program for Blood Pressure Reduction

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