Pill Box For Blood Pressure Control In Homeless Population

Overview

About this study

Hypertension (HTN) is the leading cause of cardiovascular diseases worldwide and is highly modifiable using pharmacologic and nonpharmacologic therapies.  Results from the Systolic Blood Pressure Intervention Trial (SPRINT) suggest that intensive blood pressure control to <120/80 vs. <140/90 is associated with reduced cardiovascular events and death for patients with high cardiovascular disease risk.  However, less than 50% of Americans achieve even marginal blood pressure control <140/90.  The prevalence of uncontrolled hypertension is even higher in the homeless population, which suffers from limited access to healthcare, poor nutrition, chronic stress, substance abuse and lack of consistent medication adherence.  Additional outreach support may be necessary to improve blood pressure (BP) control and reduce cardiovascular risk in this vulnerable population.  

The purpose of this project is to improve blood pressure control among a cohort of homeless and underserved patients over a 6 month period. Our target group is already participating in the Sulzbacher Center's protocol with the National Hypertension Control Initiative (NHCI), an evidence-based community program with the goal to reduce high blood pressure, in under-resourced neighborhoods.  We aim to enhance patient education on HTN and enroll eligible patients in an additional pillbox initiative to improve medication adherence.  The protocol will be as follows: 

Adult patients (aged > 18 years) with hypertension, who receive primary care and cardiovascular care through the Sulzbacher Clinic in Jacksonville, FL will be eligible for participation. Participants will be screened for hypertension during regular vital sign checks in clinic triage.  Patients with known hypertension on BP medications and those found to have hypertension (BP > 130/80) during triage will be educated on the details of the study and the risks and benefits of enrollment. Patients will be given oral informed consent, which will highlight that there is no financial benefit for enrollment and that participants may withdraw from the study at any point.    Patients who offer oral informed consent will be enrolled.  

Following enrollment, patients will receive a BP cuff and be instructed on how to use it, as is already being copmleted as part of the Sulzbacher's NHCI protocol. They will be asked to keep a BP log and to bring their log to follow-up visits. They will be prescribed antihypertensives as indicated by routine clinical care.  Pharmacological management of hypertension will be made per the discretion of the visit provider (Sulzbacher and/or Mayo Clinic advance practice provider or physician).  For the current study, BP medications will then be placed in a 1 month pill box on the day of enrollment and refilled at each subsequent visit.  Compliance will be measured by pill counts remaining in their box at each follow-up visit and self-reported adherence at follow-up. Follow-up visits will be conducted as dictated by routine medical care, and prescription refills with pill box will be supplied monthly in person.  Patients will be educated on pharmacological and nonpharmacological therapies for BP management by research staff and the visit provider.  

The primary outcomes measured will be medication compliance and percentage of patients with hypertension control at 1 month and 6 months.  We aim to improve compliance by 10% and to improve the percentage of patients with BP < 130/80 by more than 10% above baseline.  

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Eligible patients will be adults (age > 18 years) with homelessness and hypertension who receive their primary care from the Sulzbacher Clinic in Jacksonville, Florida and who provide informed consent. 

Exclusion Criteria: 

  • Patients who have cognitive impairments or who become pregnant or incarcerated during the study will be excluded.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 6/19/23. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Jacksonville, Fla.

Mayo Clinic principal investigator

Brian Shapiro, M.D., M.A.

Closed-enrolling by invitation

What is this? (?)
"Close"
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

More information

Publications

Publications are currently not available

Additional contact information

Non-cancer trials contact form

Phone: 800-664-4542 (toll-free)

International patient clinical studies questions