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出境医 / 临床实验 / Stroke Telemedicine Outpatient Prevention Program for Blood Pressure Reduction (STOP-Stroke)

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

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 Intervention/treatment Phase
Stroke Prevention Blood Pressure Telemedicine Psychosocial Impairment 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 Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 4, 2019
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : June 1, 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
Layout table for eligibility information
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

Locations
Layout table for location information
United States, Texas
University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
National Center for Advancing Translational Science (NCATS)
Investigators
Layout table for investigator information
Principal Investigator: Anjail Sharrief The University Of Texas Health Science Center of Houston
Tracking Information
First Submitted Date  ICMJE April 18, 2019
First Posted Date  ICMJE April 23, 2019
Last Update Posted Date September 9, 2020
Actual Study Start Date  ICMJE March 4, 2019
Estimated Primary Completion Date June 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 18, 2019) 		Daytime Ambulatory Systolic Blood Pressure [ Time Frame: 6 months after enrollment ]
Blood pressure will be assessed with an ambulatory blood pressure monitor (ABPM).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 18, 2019)
  • Daytime ambulatory diastolic blood pressure [ Time Frame: 6 months ]
    Blood pressure will be assessed with an ambulatory blood pressure monitor (ABPM).
  • Night time ambulatory systolic blood pressure [ Time Frame: 6 months ]
    Blood pressure will be assessed with an ambulatory blood pressure monitor (ABPM).
  • Nighttime diastolic blood pressure [ Time Frame: 6 months ]
    Blood pressure will be assessed with an ambulatory blood pressure monitor (ABPM).
  • Body Mass index(BMI) [ Time Frame: 6 months ]
    BMI will be calculated from height and weight.
  • 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.
  • 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.
  • Self-efficacy for taking medication as prescribed as assessed by the Medication Adherence Self-Efficacy Scale (MASES) [ Time Frame: Baseline ]
  • Self-efficacy for taking medication as prescribed as assessed by the Medication Adherence Self-Efficacy Scale (MASES) [ Time Frame: 6 months ]
  • Medication adherence as assessed by the Morisky Medication Adherence Scale (MMAS) [ Time Frame: 6 months ]
  • Caregiver burden as assessed by the Zarit Caregiver Burden Questionnaire [ Time Frame: 6 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Stroke Telemedicine Outpatient Prevention Program for Blood Pressure Reduction
Official Title  ICMJE Stroke Telemedicine Outpatient Program (STOP) for Blood Pressure Reduction
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Stroke Prevention
  • Blood Pressure
  • Telemedicine
  • Psychosocial Impairment
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
    Interventions:
    • 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
  • Active Comparator: Usual Care
    Pharmacist evaluates patient prior to discharge and a nurse navigator contacts patient 72 hours after discharge. Patient receives educational packet.
    Interventions:
    • Behavioral: Educational Packet
    • Behavioral: Phone call at 72 hours by discharge nurse navigator
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: April 18, 2019) 		100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 1, 2021
Estimated Primary Completion Date June 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03923790
Other Study ID Numbers  ICMJE HSC-MS-18-0925
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Anjail Z Sharrief, The University of Texas Health Science Center, Houston
Study Sponsor  ICMJE The University of Texas Health Science Center, Houston
Collaborators  ICMJE National Center for Advancing Translational Science (NCATS)
Investigators  ICMJE
Principal Investigator: Anjail Sharrief The University Of Texas Health Science Center of Houston
PRS Account The University of Texas Health Science Center, Houston
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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