CompletedNot Applicable

Uncontrolled Hypertension Among the Homeless

United States123 participantsStarted 2022-09-12

Plain-language summary

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.

Who can participate

Age range

21 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Blood Pressure

Timeframe: 6 months

Medication Adherence

Timeframe: Overall over 6 months

Appointment Attendance

Timeframe: 6 months

Trial details

NCT IDNCT05187013

SponsorGeorge Washington University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09-15

Results submitted2025-07-08

View on ClinicalTrials.gov More Hypertension trials