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

• ClinicalTrials.gov Identifier: NCT03923790
• Recruitment Status: Enrolling by invitation
• First Posted: April 23, 2019
• Last Update Posted: September 9, 2020
• Sponsor: The University of Texas Health Science Center, Houston
• Collaborator: National Center for Advancing Translational Science (NCATS)
• Information provided by (Responsible Party): Anjail Z Sharrief, The University of Texas Health Science Center, Houston

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

• 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

• 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

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

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

More Information

• Responsible Party: Anjail Z Sharrief, Assistant Professor, The University of Texas Health Science Center, Houston
• ClinicalTrials.gov Identifier: NCT03923790
• Other Study ID Numbers: HSC-MS-18-0925
• First Posted: April 23, 2019
• 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; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases