HypertensionNCT05187013
Uncontrolled Hypertension Among the Homeless
A study testing mHealth for Hypertension in Homeless Persons in people with Hypertension, run by George Washington University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- mHealth for Hypertension in Homeless Persons
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Sep 2022to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
George Washington University
Washington D.C., District of Columbia, 20052
About this study
Official title: mHealth to Address Uncontrolled Hypertension Among Hypertensive Homeless Adults
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.
Read the detailed description
Project Renewal operates several urban shelters in five boroughs of NYC. Enrollment, data collection, and retention will be supported at these sites.
Patient participants will be recruited in clinics via medical record reviews and will be randomly assigned to treatment groups using a computer-assisted permuted randomization schedule with a block size of four, stratified by clinic site, severe mental illness, and active substance use disorder. Provider participants are physicians, nurse practitioners, social workers, and counselors working at Project Renewal.
The intervention will include 6 months of mHealth HTN management support via short message service (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. The control group will receive 6 months of mHealth including basic healthcare and general health promotion via SMS texts on the same schedule as the intervention group. Both groups will undergo BP measurements and adherence assessments at appointments in the shelter-clinics. All texts will be interactive and reciprocal; during the study, feedback to SMS texts, including automated and reciprocal feedback for patient-specific input, will be directly provided to patients to enhance education and behavioral changes.
Primary outcome measures will be recorded at 0, 2, 4, and 6 months, and secondary outcome measures will be collected throughout the study. Qualitative interviews with persons experiencing homelessness with HTN (n=30, 15 each arm) and providers (n=20) will be conducted at the end of the recruitment period. Trained research assistants (RA) will collect data and perform the semi-structured interviews.
During clinic visits, BP will be measured by trained clinic nurses in a seated upright position on the right arm with a properly sized cuff. Two readings will be taken at 2-minute intervals following 5 minutes of rest and will be averaged and recorded. Proportion of days covered (PDC) and pill counts will be conducted at each visit. Additional information, including appointment attendance, will be collected from the medical record.
- Conditions
- Hypertension
- Being tested
- mHealth for Hypertension in Homeless Persons
- Keywords
- Hypertension, Homeless Persons, mHealth, Short message service, texting, blood pressure, medication adherence
- Medical subject headings
- Hypertension, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mHealth for Hypertension in Homeless PersonsBehavioural
SMS text messages sent to participants' mobile phones
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: mHealth for Hypertension in Homeless Persons |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Pressure
Systolic and diastolic blood pressure readings (SBP and DBP)
Measured: 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.
Measured: Overall over 6 months
Appointment Attendance
Percentage of appointments attended
Measured: 6 months
Secondary outcomes (1)
Number of Participants Who Completed Interviews
The number of interviews that were completed concerning participants' experiences.
All data obtained are qualitative.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start12 Sep 2022
- Primary completion15 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by George Washington UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- George Washington University
- Sponsor type
- University, hospital or other
- Collaborators
- New York University, National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Principal investigator, Ramin Asgary, George Washington University
- Investigators
- Ramin Asgary, MD, MPH, Principal investigator, George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05187013
- Sponsor's protocol ID
- NCR203140
- Other IDs
- 1R21MD016201-01
- Status last verified
- Oct 2025
- First submitted
- 7 Dec 2021
- Last updated
- 27 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37903607
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- mHealth to Address Uncontrolled Hypertension Among Hypertensive Homeless Adults
- ClinicalTrials.gov ID
- NCT05187013
- Acronym / sponsor ID
- NCR203140
- Conditions
- Hypertension
- Keywords
- Hypertension, Homeless Persons, mHealth, Short message service, texting, blood pressure, medication adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- George Washington UniversityUniversity, hospital or other
- Collaborators
- New York University, National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 12 Sep 2022 (actual)
- Primary completion
- 15 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 11 Jan 2022 (actual)
- Results
- Posted 9 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Project Renewal operates several urban shelters in five boroughs of NYC. Enrollment, data collection, and retention will be supported at these sites.
Patient participants will be recruited in clinics via medical record reviews and will be randomly assigned to treatment groups using a computer-assisted permuted randomization schedule with a block size of four, stratified by clinic site, severe mental illness, and active substance use disorder. Provider participants are physicians, nurse practitioners, social workers, and counselors working at Project Renewal.
The intervention will include 6 months of mHealth HTN management support via short message service (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. The control group will receive 6 months of mHealth including basic healthcare and general health promotion via SMS texts on the same schedule as the intervention group. Both groups will undergo BP measurements and adherence assessments at appointments in the shelter-clinics. All texts will be interactive and reciprocal; during the study, feedback to SMS texts, including automated and reciprocal feedback for patient-specific input, will be directly provided to patients to enhance education and behavioral changes.
Primary outcome measures will be recorded at 0, 2, 4, and 6 months, and secondary outcome measures will be collected throughout the study. Qualitative interviews with persons experiencing homelessness with HTN (n=30, 15 each arm) and providers (n=20) will be conducted at the end of the recruitment period. Trained research assistants (RA) will collect data and perform the semi-structured interviews.
During clinic visits, BP will be measured by trained clinic nurses in a seated upright position on the right arm with a properly sized cuff. Two readings will be taken at 2-minute intervals following 5 minutes of rest and will be averaged and recorded. Proportion of days covered (PDC) and pill counts will be conducted at each visit. Additional information, including appointment attendance, will be collected from the medical record.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypertension-Specific Education | Experimental | Behavioral: mHealth for Hypertension in Homeless Persons6 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. |
| General Health Education | Other | Behavioral: mHealth for Hypertension in Homeless Persons6 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mHealth for Hypertension in Homeless PersonsSMS text messages sent to participants' mobile phones | Behavioural | General Health Education, Hypertension-Specific Education |
Primary outcome
Blood Pressure
Time frame: 6 months
Systolic and diastolic blood pressure readings (SBP and DBP)
Medication Adherence
Time frame: Overall over 6 months
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.
Appointment Attendance
Time frame: 6 months
Percentage of appointments attended
1 secondary outcome
Number of Participants Who Completed Interviews
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37903607Asgary 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ramin Asgary, MD, MPH principal investigator
George Washington University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mHealth for Hypertension in Homeless Persons in people with Hypertension, run by George Washington University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Pressure (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05187013, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2025.