Text Message Reminders for High Blood Pressure

Overseen By Leah J Bauder, MPH

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: George Washington University

Disqualifiers: Pregnancy, Recent heart attack, Stroke, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

120 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. It seems to focus on managing blood pressure through text message reminders, so you may continue your current treatment unless advised otherwise by your doctor.

What data supports the effectiveness of the treatment mHealth for Hypertension in Homeless Persons?

Research shows that text messaging has been effective in improving health care engagement and medication adherence in homeless populations, and has helped control high blood pressure in the general population. Homeless individuals are generally supportive of using text messages for health care, which suggests that this approach could be beneficial for managing high blood pressure among them. ^{1 2 3 4 5}

Is it safe to use text message reminders for managing high blood pressure?

Research on using text message reminders for managing high blood pressure, especially among homeless individuals, suggests that it is a safe approach. Participants in studies have shown positive attitudes towards receiving health-related text messages, indicating that this method is generally well-received and does not pose safety concerns. ^{1 2 4 5 6}

How is the mHealth treatment for hypertension in homeless persons unique?

This treatment uses text message reminders to help homeless individuals manage high blood pressure, which is unique because it leverages mobile health technology to improve communication and support, addressing the specific challenges faced by this population. ^{1 2 3 4 5}

Research Team

Ramin Asgary, MD, MPH

Principal Investigator

George Washington University

Eligibility Criteria

This trial is for homeless individuals over 21 with uncontrolled high blood pressure, who are not pregnant or post-partum, can consent, read/respond to texts, and haven't had recent severe cardiovascular events. They must be getting care at Project Renewal in NYC.

Inclusion Criteria

I speak English or Spanish.

Your blood pressure was too high at your last doctor's visit.

You are currently homeless.

Exclusion Criteria

I have not had a heart attack or stroke in the last 6 months.

Inability to read or respond to SMS texts

I have had an aortic aneurysm.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 6 months of mHealth HTN management support via SMS texts, including reminders for medication adherence, appointment attendance, and HTN-specific health education and support.

6 months

Regular visits at shelter-clinics for BP measurements and adherence assessments

Follow-up

Participants are monitored for changes in blood pressure, adherence to clinic visits, and adherence to medication.

6 months

BP measurements and adherence assessments at 0, 2, 4, and 6 months

Qualitative Interviews

Qualitative interviews with participants and providers to understand barriers and opportunities regarding BP control.

End of recruitment period

Treatment Details

Interventions

• mHealth for Hypertension in Homeless Persons

Trial Overview The study tests a mobile health strategy using text messages to manage hypertension among the homeless. Participants will either receive standard care texts or additional messages aimed at controlling blood pressure to see if there's an improvement.

Participant Groups

Group I: Hypertension-Specific Education Experimental Treatment 1 Intervention

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.

Group II: General Health Education Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

George Washington University

Lead Sponsor

Trials

263

Recruited

476,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

New York University

Collaborator

Trials

249

Recruited

229,000+

Findings from Research

This study will evaluate the effectiveness of a 6-month SMS texting program in reducing blood pressure and improving medication adherence among 120 adults experiencing homelessness with uncontrolled hypertension, using a randomized controlled trial design.

In addition to measuring health outcomes, the study will assess the acceptability and experiences of both patients and healthcare providers regarding the SMS intervention, providing valuable insights into its feasibility in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SMS text intervention for uncontrolled hypertension among hypertensive homeless adults in shelter clinics of New York City: protocol for a pragmatic randomised trial study. Asgary, R., Bauder, L., Naderi, R., et al.[2023]

This study will evaluate the effectiveness of a 6-month SMS texting program for managing diabetes in 100 adults experiencing homelessness, measuring changes in HbA1c and adherence to self-care activities over 9 months.

The research will also gather insights from both patients and healthcare providers to assess the acceptability and experiences of the SMS program, aiming to improve diabetes management in this underserved population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short messaging service (SMS) texting for uncontrolled diabetes among persons experiencing homelessness: Study protocol for a randomized trial. Asgary, R., Beideck, E., Naderi, R., et al.[2023]

Text messaging interventions for appointment reminders and medication adherence suggestions showed a trend towards reducing no-show rates and improving medication adherence among a homeless population, with no-show rates at 21.0% for the intervention group compared to 30.6% for the control group.

Although the results did not reach statistical significance, the intervention group reported a higher increase in self-reported medication adherence (from 8.27 to 9.84) compared to the control group (from 8.27 to 8.68), indicating potential effectiveness in enhancing patient engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Text messaging to increase patient engagement in a large health care for the homeless clinic: Results of a randomized pilot study. Kershaw, K., Martelly, L., Stevens, C., et al.[2022]

A study involving 50 homeless individuals in New York City revealed that most participants had mobile phones and were supportive of using text messaging for health care communication, such as appointment reminders and health education.

Participants preferred concise, positively framed text messages and believed that free cell phone plans could enhance their access to health care, suggesting that mobile health strategies could significantly improve health outcomes for the homeless population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceptions, Attitudes, and Experience Regarding mHealth Among Homeless Persons in New York City Shelters. Asgary, R., Sckell, B., Alcabes, A., et al.[2022]

Among 210 hypertensive patients studied in New York City shelters, 40.1% of homeless patients had uncontrolled blood pressure, which is significantly higher than the national average of 19.6% to 24.8%.

Lack of health insurance was identified as a key barrier to effective blood pressure control, while homeless patients with diabetes or multiple chronic conditions showed better management of their hypertension, suggesting that targeted health interventions could improve outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rates and Predictors of Uncontrolled Hypertension Among Hypertensive Homeless Adults Using New York City Shelter-Based Clinics. Asgary, R., Sckell, B., Alcabes, A., et al.[2022]

Among 97,366 homeless adults studied, the prevalence of self-reported hypertension was found to be 27.0%, and diabetes prevalence was 8.0%, indicating a significant burden of chronic diseases in this population.

Interestingly, the prevalence rates of hypertension and diabetes among homeless adults were similar to those in the general population, suggesting that homelessness does not necessarily increase the risk of these conditions, but highlights the need for improved healthcare and housing resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diabetes and hypertension prevalence in homeless adults in the United States: a systematic review and meta-analysis. Bernstein, RS., Meurer, LN., Plumb, EJ., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

SMS text intervention for uncontrolled hypertension among hypertensive homeless adults in shelter clinics of New York City: protocol for a pragmatic randomised trial study. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Short messaging service (SMS) texting for uncontrolled diabetes among persons experiencing homelessness: Study protocol for a randomized trial. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Text messaging to increase patient engagement in a large health care for the homeless clinic: Results of a randomized pilot study. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Perceptions, Attitudes, and Experience Regarding mHealth Among Homeless Persons in New York City Shelters. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Rates and Predictors of Uncontrolled Hypertension Among Hypertensive Homeless Adults Using New York City Shelter-Based Clinics. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Diabetes and hypertension prevalence in homeless adults in the United States: a systematic review and meta-analysis. [2022]