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Uncontrolled Hypertension Among the Homeless

mHealth to Address Uncontrolled Hypertension Among Hypertensive Homeless Adults

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05187013
Enrollment
123
Registered
2022-01-11
Start date
2022-09-12
Completion date
2025-09-30
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

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

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.

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.

Interventions

BEHAVIORALmHealth for Hypertension in Homeless Persons

SMS text messages sent to participants' mobile phones

Sponsors

New York University
CollaboratorOTHER
National Institute on Minority Health and Health Disparities (NIMHD)
CollaboratorNIH
George Washington University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Blood Pressure6 monthsSystolic and diastolic blood pressure readings (SBP and DBP)
Medication AdherenceOverall over 6 monthsMedication 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 Attendance6 monthsPercentage of appointments attended

Secondary

MeasureTime frameDescription
Number of Participants Who Completed Interviews6 monthsThe number of interviews that were completed concerning participants' experiences. All data obtained are qualitative.

Countries

United States

Participant flow

Pre-assignment details

No significant study events occurred after participant enrollment and before study assignment.

Participants by arm

ArmCount
Hypertension-Specific Education
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.
57
General Health Education
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.
56
Providers
Healthcare providers and shelter staff who participated only in semi-structured interviews. No demographic data was collected for this group.
0
Total113

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyDeath010
Overall StudyLost to Follow-up20170
Overall StudyOngoing Participants350
Overall StudyWithdrawal by Subject110

Baseline characteristics

CharacteristicGeneral Health EducationHypertension-Specific EducationTotal
Age, Continuous58.05 years
STANDARD_DEVIATION 9.66
57.53 years
STANDARD_DEVIATION 10.2
57.78 years
STANDARD_DEVIATION 9.9
Blood Pressure Baseline, Systolic, and Diastolic
Diastolic Blood Pressure
93.482 mmHG
STANDARD_DEVIATION 11.323
91.263 mmHG
STANDARD_DEVIATION 10.316
92.363 mmHG
STANDARD_DEVIATION 10.836
Blood Pressure Baseline, Systolic, and Diastolic
Systolic Blood Pressure
156.018 mmHG
STANDARD_DEVIATION 11.771
155.772 mmHG
STANDARD_DEVIATION 12.071
155.894 mmHG
STANDARD_DEVIATION 11.871
Ethnicity (NIH/OMB)
Hispanic or Latino
16 Participants14 Participants30 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
35 Participants42 Participants77 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
5 Participants1 Participants6 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants0 Participants1 Participants
Race (NIH/OMB)
Asian
1 Participants1 Participants2 Participants
Race (NIH/OMB)
Black or African American
33 Participants38 Participants71 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
2 Participants0 Participants2 Participants
Race (NIH/OMB)
Unknown or Not Reported
14 Participants11 Participants25 Participants
Race (NIH/OMB)
White
5 Participants7 Participants12 Participants
Sex: Female, Male
Female
5 Participants6 Participants11 Participants
Sex: Female, Male
Male
51 Participants51 Participants102 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 571 / 560 / 10
other
Total, other adverse events
0 / 570 / 560 / 10
serious
Total, serious adverse events
0 / 570 / 560 / 10

Outcome results

Primary

Appointment Attendance

Percentage of appointments attended

Time frame: 6 months

ArmMeasureValue (MEAN)Dispersion
Hypertension-Specific EducationAppointment Attendance46.08 PercentageStandard Deviation 35.81
General Health EducationAppointment Attendance57.41 PercentageStandard Deviation 33.51
Comparison: Null hypothesis: No difference in appointment adherence between the study armsp-value: 0.3295% CI: [-0.58, 0.19]Regression, Logistic
Primary

Blood Pressure

Systolic and diastolic blood pressure readings (SBP and DBP)

Time frame: 6 months

ArmMeasureGroupValue (MEAN)Dispersion
Hypertension-Specific EducationBlood PressureSystolic Blood Pressure135.36 mmHGStandard Deviation 18.31
Hypertension-Specific EducationBlood PressureDiastolic Blood Pressure89.67 mmHGStandard Deviation 10.71
General Health EducationBlood PressureSystolic Blood Pressure136.19 mmHGStandard Deviation 15.68
General Health EducationBlood PressureDiastolic Blood Pressure92.38 mmHGStandard Deviation 82.22
Comparison: Null Hypothesis: No improvement between baseline and final SBP, i.e., Final SBP - Baseline SBP \>= 0 Alternative Hypothesis: Final SBP - Baseline SBP \<0 Power calculation: Based on the data, the mean and SD of the change in SBP are -7.16 and 21.40, respectively. Using a one-sided paired t-test with a significance level of 0.05, we should have a power of 83.16%p-value: 0.00695% CI: [-12.59, -1.73]t-test, 1 sided
Comparison: Null Hypothesis: No improvement between baseline and final DBP, i.e., Final DBP - Baseline DBP \>= 0 Alternative Hypothesis: Final DBP - Baseline DBP \<0 Power calculation: Based on the data, the mean and SD of the change in SBP are -2.15 and 10.49, respectively. Using a one-sided paired t-test with a significance level of 0.05, we should have a power of 51.48%p-value: 0.05695% CI: [-4.79, 0.49]t-test, 1 sided
Comparison: Null hypothesis: No difference between the change in SBP between the two arms~Power calculation: With our sample size, we expect to have 80% power as long as the effect size is at least 0.72 at a 5% level.p-value: 0.8795% CI: [-8.76, 7.42]ANCOVA
Comparison: Null hypothesis: No difference between the change in DBP between the two arms~Power calculation: With our sample size, we expect to have 80% power as long as the effect size is at least 0.72 at a 5% level.p-value: 0.6395% CI: [-3.02, 4.98]ANCOVA
Primary

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.

Time frame: Overall over 6 months

ArmMeasureValue (MEDIAN)
Hypertension-Specific EducationMedication Adherence83.3 Percentage of Adherent Participants
General Health EducationMedication Adherence50 Percentage of Adherent Participants
Comparison: Null hypothesis: There is no difference in medicine adherence between the two groupsp-value: 0.1495% CI: [-0.26, 2.29]Regression, Logistic
Secondary

Number of Participants Who Completed Interviews

The number of interviews that were completed concerning participants' experiences. All data obtained are qualitative.

Time frame: 6 months

Population: The number of participants interviewed from each group is below.

ArmMeasureValue (NUMBER)
Hypertension-Specific EducationNumber of Participants Who Completed Interviews13 Participants who Completed Interviews
General Health EducationNumber of Participants Who Completed Interviews6 Participants who Completed Interviews
ProvidersNumber of Participants Who Completed Interviews10 Participants who Completed Interviews

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026