Stroke Telemedicine Outpatient Prevention Program for Blood Pressure Reduction

Blood Pressure Clinical Trial

— STOP-Stroke  

Official title:

Stroke Telemedicine Outpatient Program (STOP) for Blood Pressure Reduction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03923790
• Other study ID #: HSC-MS-18-0925
• Status: Completed
• Phase: N/A
• Start date: March 4, 2019
• Est. completion date: October 14, 2021

Study information

• Verified date: October 2022
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: October 14, 2021
• Est. primary completion date: October 14, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure
• Psychosocial Impairment
• Stroke
• Stroke Prevention
• Telemedicine

Intervention

Behavioral:
• Educational Packet
The patient will receive an educational packet.
• 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
• 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.
• 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.

Locations

Country	Name	City	State
United States	University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	National Center for Advancing Translational Sciences (NCATS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Caregiver Burden as Assessed by the Zarit Caregiver Burden Questionnaire		6 months
Other	Medication Adherence as Assessed by the Morisky Medication Adherence Scale (MMAS)		6 months
Other	Self-efficacy for Taking Medication as Prescribed as Assessed by the Medication Adherence Self-Efficacy Scale (MASES)		6 months
Other	Self-efficacy for Taking Medication as Prescribed as Assessed by the Medication Adherence Self-Efficacy Scale (MASES)		Baseline
Primary	Daytime Ambulatory Systolic Blood Pressure	Blood pressure will be assessed with an ambulatory blood pressure monitor (ABPM).	6 months after enrollment
Secondary	Daytime Ambulatory Diastolic Blood Pressure	Blood pressure will be assessed with an ambulatory blood pressure monitor (ABPM).	6 months
Secondary	Night Time Ambulatory Systolic Blood Pressure	Blood pressure will be assessed with an ambulatory blood pressure monitor (ABPM).	6 months
Secondary	Nighttime Diastolic Blood Pressure	Blood pressure will be assessed with an ambulatory blood pressure monitor (ABPM).	6 months
Secondary	Body Mass Index(BMI)	BMI will be calculated from height and weight.	6 months
Secondary	Number of Participants With Recurrent Vascular Events (Stroke, Myocardial Infarction, Acute Cardiac Death)	Recurrent vascular events include stroke, myocardial infarction, or acute cardiac death.	6 months
Secondary	Number of Participants With Acute Healthcare Utilization	Acute healthcare utilization includes hospital readmission and acute care visits to emergency room and/or urgent care.	6 months