About Bolder Science

Our mission is to provide healthcare professionals with unbiased clinical research information, easily.

Currently, you can access the following clinical trials being conducted worldwide:

359,057 studies
in
219 countries
Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/25/2021.
This website is for US healthcare professionals

Log In to Bolder Science

or

Don't have an account? Sign Up

Please enter your email address.

You will receive a link to create a new password via email.

Log In

Create an Account

or
(optional) ?

Welcome, !

Please complete the following 4 questions to ensure you receive the information that best suits your needs.

Clinical Trials of Interest

When I’m looking for information on clinical trials, I usually am interested in...

finding clinical trials in which to enroll my patients

Rarely Often

finding newly launched clinical trials (for all phases)

Rarely Often

updates on status changes for clinical trials

Rarely Often

pipeline molecules

Rarely Often

Drug Interventions

Enter up to 3 drug interventions you are currently interested in:

Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/25/2021.

Stroke Telemedicine Outpatient Prevention Program for Blood Pressure Reduction

Clinicaltrials.gov identifier NCT03923790

Recruitment Status Enrolling by invitation

First Posted April 23, 2019

Last update posted September 9, 2020

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.

  • Condition or Disease:Stroke Prevention
    Blood Pressure
    Telemedicine
    Psychosocial Impairment
  • 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
  • Phase: N/A
Detailed Description

N/A

Study Design
  • Study Type: Interventional
  • Estimated Enrollment: 100 participants
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: Single (Outcomes Assessor)
  • Primary Purpose: Treatment
  • Official Title: Stroke Telemedicine Outpatient Program (STOP) for Blood Pressure Reduction
  • Actual Study Start Date: March 2019
  • Estimated Primary Completion Date: June 2021
  • Estimated Study Completion Date: June 2021
Arms and interventions
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
Outcome Measures
  • Primary Outcome Measures: 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 Outcome Measures: 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.
  • 7. Self-efficacy for taking medication as prescribed as assessed by the Medication Adherence Self-Efficacy Scale (MASES) [ Time Frame: Baseline ]
  • 8. Self-efficacy for taking medication as prescribed as assessed by the Medication Adherence Self-Efficacy Scale (MASES) [ Time Frame: 6 months ]
  • 9. Medication adherence as assessed by the Morisky Medication Adherence Scale (MMAS) [ Time Frame: 6 months ]
  • 10. Caregiver burden as assessed by the Zarit Caregiver Burden Questionnaire [ Time Frame: 6 months ]
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
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

Contacts and Locations
Contacts
Locations

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

Sponsors and Collaborators

The University of Texas Health Science Center, Houston

National Center for Advancing Translational Science (NCATS)

Investigators

Principal Investigator: Anjail Sharrief The University Of Texas Health Science Center of Houston

More Information
  • Responsible Party: The University of Texas Health Science Center, Houston
  • ClinicalTrials.gov Identifier: NCT03923790 History of Changes
  • Other Study ID Numbers: HSC-MS-18-0925
  • First Posted: April 23, 2019 Key Record Dates
  • Last Update Posted: September 9, 2020
  • Last Verified: September 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: Yes
  • Additional relevant MeSH terms: Stroke