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| ID | Type | Description | Link |
|---|---|---|---|
| 1R21MD016201-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| New York University | OTHER |
| National Institute on Minority Health and Health Disparities (NIMHD) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mHealth for Hypertension in Homeless Persons | Behavioral | SMS text messages sent to participants' mobile phones |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Completed Interviews | The number of interviews that were completed concerning participants' experiences. All data obtained are qualitative. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ramin Asgary, MD, MPH | George Washington University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| George Washington University | Washington D.C. | District of Columbia | 20052 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37903607 | Derived | 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. |
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No significant study events occurred after participant enrollment and before study assignment.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | Providers | Healthcare providers who participated in the semi-structured interview only. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
Providers only participated in semi-structured interviews. No baseline or demographic data were collected for this group.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Blood Pressure | Systolic and diastolic blood pressure readings (SBP and DBP) | Posted | Mean | Standard Deviation | mmHG | 6 months |
|
From enrollment to the completion of the Intervention period, up to 6 Months.
One participant died during the study period; this death was unrelated to the intervention.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ramin Asgary | George Washington University | (202) 994-6803 | raminasgary1@gwu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 26, 2021 | Jul 8, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 26, 2021 | Jul 8, 2025 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Patient Informed Consent Form | Jan 26, 2021 | Jul 8, 2025 | ICF_002.pdf |
| ICF | No | No | Yes | Informed Consent Form: Provider Informed Consent Form | Jan 26, 2021 | Jul 8, 2025 | ICF_003.pdf |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
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| ID | Term |
|---|---|
| D017216 | Telemedicine |
| ID | Term |
|---|---|
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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| Lost to Follow-up |
|
| Ongoing Participants |
|
| BG001 | 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. |
| BG002 | Providers | Healthcare providers and shelter staff who participated only in semi-structured interviews. No demographic data was collected for this group. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Blood Pressure Baseline, Systolic, and Diastolic | Baseline values for participants' blood pressure values, both systolic and diastolic | Mean | Standard Deviation | mmHG |
|
|
|
|
| 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. | Posted | Median | Inter-Quartile Range | Percentage of Adherent Participants | Overall over 6 months |
|
|
|
|
| Primary | Appointment Attendance | Percentage of appointments attended | Posted | Mean | Standard Deviation | Percentage | 6 months |
|
|
|
|
| Secondary | Number of Participants Who Completed Interviews | The number of interviews that were completed concerning participants' experiences. All data obtained are qualitative. | The number of participants interviewed from each group is below. | Posted | Number | Participants who Completed Interviews | 6 months |
|
|
|
| 0 |
| 57 |
| 0 |
| 57 |
| 0 |
| 57 |
| EG001 | 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. | 1 | 56 | 0 | 56 | 0 | 56 |
| EG002 | Providers | Healthcare providers and shelter staff who participated only in semi-structured interviews. No adverse event data were collected for this group. | 0 | 10 | 0 | 10 | 0 | 10 |
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| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |