Stroke Telemedicine Outpatient Prevention Program for Blood Pressure Reduction

Stroke Telemedicine Outpatient Program (STOP) for Blood Pressure Reduction

Sponsors

Lead Sponsor: The University of Texas Health Science Center, Houston

Collaborator: National Center for Advancing Translational Science (NCATS)

Source The University of Texas Health Science Center, Houston
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.

Overall Status Enrolling by invitation
Start Date March 4, 2019
Completion Date June 1, 2020
Primary Completion Date December 1, 2019
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Daytime Ambulatory Systolic Blood Pressure 6 months after enrollment
Secondary Outcome
Measure Time Frame
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
Number of participants with acute healthcare utilization 6 months
Self-efficacy for taking medication as prescribed as assessed by the Medication Adherence Self-Efficacy Scale (MASES) Baseline
Self-efficacy for taking medication as prescribed as assessed by the Medication Adherence Self-Efficacy Scale (MASES) 6 months
Medication adherence as assessed by the Morisky Medication Adherence Scale (MMAS) 6 months
Caregiver burden as assessed by the Zarit Caregiver Burden Questionnaire 6 months
Enrollment 100
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: Educational Packet

Description: The patient will receive an educational packet.

Intervention Type: Behavioral

Intervention Name: Phone call at 72 hours by discharge nurse navigator

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

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.

Arm Group Label: STOP model

Intervention Type: Behavioral

Intervention Name: Educational messages every other week

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

Arm Group Label: STOP model

Intervention Type: Diagnostic Test

Intervention Name: BP monitoring by QardioARM with periodic transmission of BP data

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.

Arm Group Label: STOP model

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Anjail Sharrief Principal Investigator The University Of Texas Health Science Center of Houston
Location
Facility: University of Texas Health Science Center at Houston
Location Countries

United States

Verification Date

April 2019

Responsible Party

Type: Principal Investigator

Investigator Affiliation: The University of Texas Health Science Center, Houston

Investigator Full Name: Anjail Z Sharrief

Investigator Title: Assistant Professor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: STOP model

Type: Experimental

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.

Label: Usual Care

Type: Active Comparator

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

Acronym STOP-Stroke
Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Single (Outcomes Assessor)

Source: ClinicalTrials.gov