Stroke Telemedicine Outpatient Prevention Program for Blood Pressure Reduction

NCT ID: NCT03923790

Last Updated: 2022-11-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 83 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-04
• Study Completion Date: 2021-10-14

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.

Conditions

Stroke Prevention; Blood Pressure; Telemedicine; Psychosocial Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Educational Packet

Intervention Type: BEHAVIORAL

The patient will receive an educational packet.

Phone call at 72 hours by discharge nurse navigator

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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

Intervention Type: 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.

Usual Care

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

Group Type: ACTIVE_COMPARATOR

Educational Packet

Intervention Type: BEHAVIORAL

The patient will receive an educational packet.

Phone call at 72 hours by discharge nurse navigator

Intervention Type: 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

Interventions

Educational Packet

The patient will receive an educational packet.

Intervention Type: 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

Intervention Type: 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.

Intervention Type: 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

Intervention Type: BEHAVIORAL

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.

Intervention Type: DIAGNOSTIC_TEST

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center for Advancing Translational Sciences (NCATS)

NIH

Sponsor Role: collaborator

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Anjail Z Sharrief

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anjail Sharrief

Role: PRINCIPAL_INVESTIGATOR

The University Of Texas Health Science Center of Houston

Locations

University of Texas Health Science Center at Houston

Houston, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

HSC-MS-18-0925

Identifier Type: -

Identifier Source: org_study_id