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Uncontrolled Hypertension Among the Homeless
This study is designed to assess the effect of implementing a mobile health (mHealth) strategy using text messaging for hypertension (HTN) management among hypertensive homeless persons with uncontrolled blood pressure age 21 or older in shelter-clinics in New York City (NYC). The study uses a randomized clinical trial design (homeless, n=120) and semi-structured interviews (homeless, n=30; providers, n=20). The control group will receive text messages for usual standard care/healthy lifestyle during a 6-month follow-up period. The intervention group will receive text messages geared towards both standard care/healthy lifestyle and blood pressure control. At the end of study period, the investigators will assess changes in blood pressure (BP) measurements, adherence to clinic visits, and adherence to medication, and the investigators will compare them between the two groups. Qualitative interviews with both patients and providers who provide services to the homeless in shelter settings will develop a better understand barriers and opportunities regarding BP control. The investigators hypothesize that those individuals randomized to the intervention will experience a reduction in blood pressure (8mmHg systolic BP or diastolic BP) and will exhibit better adherence to blood pressure medications and appointments compared to the control group.
Conditions:
🦠 Hypertension
🗓️ Study Start (Actual) 12 September 2022
🗓️ Primary Completion (Estimated) 31 January 2024
✅ Study Completion (Estimated) 1 November 2024
👥 Enrollment (Estimated) 120
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE3
Locations:
📍 Washington, District of Columbia, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Currently experiencing homelessness
    • * Current diagnosis of hypertension
    • * SBP above 140mmHg or DBP above 90mmHg at most recent clinic visit
    • * English or Spanish speaking
    • * Currently presenting to Project Renewal shelter-clinics for medical care
    • * Connected to multidisciplinary social and health services at Project Renewal

    Exclusion Criteria:

    • * Pregnant or within 3 months post-partum
    • * Heart attack or stroke within previous 6 months
    • * History of aortic aneurysm
    • * Diagnosis of end-stage renal disease or currently on dialysis
    • * Inability to read or respond to SMS texts
    • * Any condition preventing participants from providing informed consent
    • * SBP \>175mmHg or DBP \>105mmHg unless medical provider determines patient has no symptoms suggesting a hypertensive emergency or urgency
Ages Eligible for Study: 21 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 7 December 2021
  • First Submitted that Met QC Criteria 21 December 2021
  • First Posted 11 January 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 10 May 2024
  • Last Update Posted 13 May 2024
  • Last Verified May 2024
I'm interested ...!!