Uncontrolled Hypertension Among the Homeless

NCT05187013 | Completed Results DMC

• 2 other identifiers: NCR2031401R21MD016201-01
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypertension

Keywords

Hypertension; Homeless Persons; mHealth; Short message service; texting; blood pressure; medication adherence

Outcome Measures

Primary Outcomes (3)

• Blood Pressure

  Systolic and diastolic blood pressure readings (SBP and DBP)

  6 months

• Medication Adherence

  Medication adherence was measured using the Voils 3-Item DOSE-Nonadherence measure, a 5-item Likert scale. This was measured by dichotomizing the response options such that any score of 2-5 on any of the three Extent of Non-adherence items is considered non-adherent (e.g., code as 1), and a response of 1 (none of the time) on all items is considered adherent (e.g., code as 0). The extent of adherence was then reported as a median percentage of the total participants with an IQR range as reflected below.

  Overall over 6 months

• Appointment Attendance

  Percentage of appointments attended

  6 months

Secondary Outcomes (1)

• Number of Participants Who Completed Interviews

  6 months

Study Arms (2)

Hypertension-Specific Education

EXPERIMENTAL

6 months of mHealth HTN management support via SMS texts including reminders for medication adherence, appointment attendance, and HTN-specific health education and support. Texts will be delivered to support medication adherence and lifestyle changes, and participants will receive appointment reminders before each appointments with a follow-up text and robocall if the appointment is missed.

Behavioral: mHealth for Hypertension in Homeless Persons

General Health Education

OTHER

6 months of mHealth including basic healthcare and general health promotion via SMS texts. Blood pressure measurements and adherence assessments will be collected at every shelter visit.

Behavioral: mHealth for Hypertension in Homeless Persons

Interventions

mHealth for Hypertension in Homeless Persons BEHAVIORAL

SMS text messages sent to participants' mobile phones

General Health Education; Hypertension-Specific Education

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• George Washington University: lead
• New York University: collaborator
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

Study Sites (1)

George Washington University

Washington D.C., District of Columbia, 20052, United States

Location

Related Publications (1)

• Asgary R, Bauder L, Naderi R, Ogedegbe G. SMS text intervention for uncontrolled hypertension among hypertensive homeless adults in shelter clinics of New York City: protocol for a pragmatic randomised trial study. BMJ Open. 2023 Oct 30;13(10):e073041. doi: 10.1136/bmjopen-2023-073041.

  PMID: 37903607 DERIVED

MeSH Terms

Conditions

Hypertension; Medication Adherence

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration

Limitations and Caveats

We faced some challenges with enrollment due to post-pandemic constraints and the unexpected influx of newcomers into the shelter system in New York City, which were later resolved, and we added another enrollment site.

Results Point of Contact

• Title: Ramin Asgary
• Organization: George Washington University

raminasgary1@gwu.edu

(202) 994-6803

Study Officials

• Ramin Asgary, MD, MPH

  George Washington University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 7, 2021
• First Posted: January 11, 2022
• Study Start: September 12, 2022
• Primary Completion: September 15, 2025
• Study Completion: September 30, 2025
• Last Updated: October 27, 2025
• Results First Posted: September 9, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)