Health Support Interventions for Blood Pressure Control

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Part-time driver, CVD, others

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

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help taxi drivers manage high blood pressure and reduce cancer risk by promoting healthy weight and increasing cancer screenings. Participants will attend health fairs and may receive text messages and home blood pressure monitoring devices. Some will also get extra support from family or friends to encourage healthy habits. This trial could suit male taxi drivers with high blood pressure who have been licensed for at least three months in NYC. Participants should be ready to stay in NYC for the next nine months and have a cell phone for receiving texts.

As an unphased trial, this study offers a unique opportunity to contribute to research that could improve health outcomes for taxi drivers.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on monitoring and managing blood pressure rather than changing existing treatments.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that using text messages along with home blood pressure monitoring safely aids in managing blood pressure. Studies have found that text messages increase involvement, prompting more frequent checks and sharing of blood pressure readings. This method has been linked to better blood pressure control and earlier diagnoses of high blood pressure, facilitating quicker management of the condition.

When social network support is added to text messaging and home monitoring, research also shows it is safe and effective. Digital tools like these can improve blood pressure, especially for those with limited access to healthcare. This approach encourages adherence to treatment plans and has improved quality of life.

Overall, these methods are well-tolerated, with no major reports of negative effects. They leverage everyday technology and social support to help people manage their blood pressure safely and effectively. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these interventions for blood pressure control because they incorporate innovative technology and social support, which are not standard features in most current treatments. Unlike traditional methods that primarily rely on medication and regular doctor visits, these interventions use text messaging and home blood pressure monitoring to engage patients actively in managing their health. Additionally, the inclusion of social network support distinguishes one of the interventions by involving family and peers to encourage healthy behaviors, which could enhance motivation and adherence to blood pressure management. This multifaceted approach aims to empower individuals to take control of their health in a more interactive and supportive way.

What evidence suggests that this trial's treatments could be effective for blood pressure control?

This trial will compare different health support interventions for blood pressure control. One treatment arm uses text messages and home blood pressure monitoring, which research has shown can help manage high blood pressure. Studies found that sending text reminders to check blood pressure helps people maintain control, with over 64% of participants seeing improvements. Another arm in this trial adds social network support, where friends or family encourage healthy habits. However, some research suggests that support from others alone might not significantly aid blood pressure control. Overall, combining text messages and home monitoring appears promising for effectively managing blood pressure. ^{2 6 7 8 9}

Who Is on the Research Team?

Francesca Gany, MD, MPH

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for male taxi drivers over 19 years old in NYC with high blood pressure, who plan to stay in the city for at least 9 months. They must have a cell phone capable of receiving texts and speak English, Spanish, Bengali, Urdu, or French. Part-time drivers and those with cardiovascular diseases other than hypertension are excluded.

Inclusion Criteria

Hypertensive-level readings over three weeks, with at least two of three elevated BP readings (systolic ≥140 and/or diastolic ≥90); OR One hypertensive crisis readings (systolic ≥165 and/or diastolic ≥100) {eligible for the study without having to return for second or third readings} OR have a known diagnosis of hypertension and have elevated values at one reading {eligible for the study without having to return for second or third readings}

You can speak English, Spanish, Bengali, Urdu, or French.

Over 19 years of age (we are selecting participants older than three years past the legal driving age of 16, as younger drivers tend to change jobs more often)

Exclusion Criteria

Part-time driver (drives fewer than 35 hours per week). Although it is highly unlikely for NYC taxi drivers to work for multiple garages at study baseline, drivers may switch jobs and/or their garage base affiliation while participating in this study. New jobs and/or garage base affiliations will be tracked during follow-up assessments and noted for potential limitations with study retention and intervention contamination. Drivers will be allowed to continue the study even if they are no longer working with the initial garage base.

You have or had heart problems such as coronary artery disease, angina or aortic stenosis. High blood pressure is not included.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person or virtual)

Health Fair Follow-up

Participants undergo health fair follow-up with regular or urgent follow-up based on health status

2-4 weeks

Regular follow-up for at least 2 weeks, urgent follow-up for at least 1 month

Intervention

Participants receive mobile text messaging intervention and home BP monitoring for blood pressure management

9 months

Ongoing interaction via mobile text messaging

Follow-up

Participants are monitored for changes in blood pressure levels and other health metrics

9 months

What Are the Treatments Tested in This Trial?

Interventions

• CONTROL- Usual & Customary Health Fair Follow-up
• Health Fair + TECH [Text Messaging + Home Blood Pressure Monitoring]
• Health Fair + TECH [Text Messaging + Home Blood Pressure Monitoring] + Social Network Support (SNS)

Trial Overview

The study tests different follow-up methods after Health Fairs to manage high blood pressure and reduce cancer risk among taxi drivers. It compares usual health fair follow-ups with additional tech support like text messaging and home monitoring plus social network support.

How Is the Trial Designed?

Group I: Health Fairs (HF) Experimental Treatment 1 Intervention

Drivers will undergo U\&C Health Fair follow-up either Regular or Urgent Follow-up: Timeline is determined by health status, with regular follow-up continuing for at least two weeks and urgent follow-up continuing for at least a month

Group II: HF +Tech + social network support (SNS). Experimental Treatment 1 Intervention

Drivers will receive: U\&C HF follow-up, Mobile text messaging intervention w/ interactive 2- way messaging to encourage BP management for nine months and home BP monitoring equipment with instructions to self-monitor BP for nine months A social network support intervention in which selected family/peers encourage drivers to maintain healthy behaviors for nine months

Group III: HF + text messaging + home BP monitoring Experimental Treatment 1 Intervention

Drivers will receive: U\&C HF follow-up, Mobile text messaging intervention w/ interactive 2- way messaging to encourage BP management for nine months A home BP monitoring equipment with instructions to self-monitor BP for nine months

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Published Research Related to This Trial

The study will evaluate the effectiveness of self-measured blood pressure monitoring (SMBP) using cellular-enabled devices in safety-net clinics, targeting patients with hypertension and aiming to improve blood pressure management without needing Wi-Fi or Bluetooth.

It will compare three levels of implementation support for SMBP, including minimal support, protocol-based reminders, and pharmacist-led coaching, to determine which approach best helps patients achieve better blood pressure control and overall health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized trial protocol for remote monitoring for equity in advancing the control of hypertension in safety net systems (REACH-SNS) study. Fontil, V., Khoong, EC., Green, BB., et al.[2023]

A systematic review of 51 studies found that eHealth interventions, particularly using more than two types, phone calls, and smartphone apps, significantly reduced both systolic and diastolic blood pressure, indicating their efficacy in managing hypertension.

Smartphone apps improved medication adherence by 45%, while other eHealth methods enhanced physical activity compliance and blood pressure control, suggesting that these digital tools can effectively support patients in managing their hypertension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative effect of eHealth interventions on hypertension management-related outcomes: A network meta-analysis. Cavero-Redondo, I., Saz-Lara, A., Sequí-Dominguez, I., et al.[2022]

Home blood pressure telemonitoring (HBPT) has been shown to improve patient compliance and hypertension control rates, based on randomized controlled trials, although the overall evidence for blood pressure reduction is considered 'moderate'.

Despite the potential of digital health interventions, there is a lack of high-quality evidence regarding the accuracy and safety of mobile applications for hypertension management, indicating that not all available apps are suitable for clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of arterial hypertension: home blood pressure measurement is a cornerstone for telemonitoring and self-management. Postel-Vinay, N., Bobrie, G., Asmar, R., et al.[2023]

In a pilot study involving 19 hypertensive patients over six months, the Health data Monitoring System (HMS) led to an increase in patients reaching their blood pressure goals from 16% to 37%.

The mean home systolic blood pressure decreased significantly from 138.1 mmHg to 130.2 mmHg, suggesting that regular monitoring with HMS can effectively support hypertension management, especially in men.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A prospective pilot trial of the health data monitoring system without educational content for patients with hypertension. Kishi, T., Usui, H., Nagayoshi, S.[2023]

Ambulatory blood pressure monitoring is essential for managing hypertension, and home monitoring is preferred by patients, highlighting the importance of patient-centered approaches in treatment.

Despite the rise of smartphone apps for blood pressure monitoring, only two apps align with European Society of Hypertension guidelines, indicating a need for better collaboration between tech developers and healthcare professionals to ensure patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home blood pressure measurement and digital health: communication technologies create a new context. Postel-Vinay, N., Bobrie, G., Savard, S., et al.[2019]

Citations

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Text Messaging for Hypertension Gets High Ratings - Penn LDI

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Effect of digital messaging on blood pressure control in ...

Adequate BP control was achieved in the 64.3% of the total population on average during the 20 months of the study period (Table 1). Some PCNs ...

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Text Messaging and Home Blood Pressure Monitoring for ...

Preliminary studies have shown that SMS text messaging and HBPM can be effective in promoting medication adherence and BP control [Lauffenburger ...

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Automated Text Message–Based Program to Improve ...

Text messaging can improve engagement, with patients more likely to measure and submit BPs than via office follow-up or other modes of outreach.

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globalheartjournal.com

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Effectiveness and Acceptability of a Mobile Phone Text ...

The TEXT4BP study provides promising evidence that text messaging intervention is feasible, acceptable, and effective to improve BP control in low-resource ...

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sciencedirect.com

sciencedirect.com/science/article/pii/S2666602223000058

TEXT MY BP MEDS NOLA: A pilot study of text-messaging ...

This study indicates that daily text messages significantly improve medication adherence and SBP lowering. 2. Text message systems are a low-cost and minimally ...

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Clinician Decisions After Remote Notification of Elevated ...

These findings suggest that EHR alerts for elevated BP during remote monitoring were effective in prompting a mix of remote and office-based management.