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

166 Participants Needed

Trial Summary

What is the purpose of this trial?

In our past work it was found that many drivers had high blood pressure, and lifestyles that led to being overweight and not having cancer screenings performed. The investigators are now adding to the Health Fairs' usual program different ways of following up with drivers who attend our Health Fairs. The investigators are doing this because they want to find the best way to help drivers manage high blood pressure, and reduce cancer risk, by maintaining a healthy weight and increasing colorectal cancer screening. Health screenings will be conducted by trained personnel, and a physician or nurse will provide a health consult in person or over the phone (via MSK-issued phone/video/audio devices). In the event that participants are unable to meet in person for biometric measurements, staff will accept their self-reported weight, blood pressure, and waist circumference over the phone. Staff may mail blood pressure machines (to participants who did not receive them at baseline), scales, and measuring tapes to participants to assist in the completion of self-reported biometric measures. Along with supplies, participants may also receive a letter asking for the confirmation of supply receipt. \* If critically abnormal values are identified during the health fair, under the advisement of the clinician, the driver may be escorted by trained staff directly to a health care facility for immediate medical follow-up

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.

What data supports the effectiveness of the treatment for blood pressure control?

Research shows that using text messaging and home blood pressure monitoring can help people manage their blood pressure better. These tools have been effective in improving medication adherence and achieving blood pressure goals, with studies indicating significant improvements in blood pressure control when these methods are used. ^{1 2 3 4 5}

Is the Health Support Intervention for Blood Pressure Control safe for humans?

The available research on similar interventions, like text messaging and home blood pressure monitoring, suggests they are generally safe for managing blood pressure. These methods have been used to improve communication between patients and doctors, and no specific safety concerns have been reported in the studies. ^{3 5 6 7 8}

What makes the Health Support Interventions for Blood Pressure Control treatment unique?

This treatment is unique because it combines traditional health fair follow-ups with modern technology like text messaging and home blood pressure monitoring, and adds social network support to enhance blood pressure management. This approach leverages digital health tools to improve adherence and self-monitoring, which is not typically part of standard hypertension treatments. ^{2 9 10 11 12}

Research Team

Francesca Gany, MD, MPH

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

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

Effectiveness, reach, uptake, and feasibility of digital health interventions for adults with hypertension: a systematic review and meta-analysis of randomised controlled trials. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Comparative effect of eHealth interventions on hypertension management-related outcomes: A network meta-analysis. [2022]

3. Canada pubmed.ncbi.nlm.nih.gov

Text Messaging and Home Blood Pressure Monitoring for Patients with Uncontrolled Hypertension: Proposal for a Feasibility Pilot Randomized Controlled Trial. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

[Text messaging and self-care support of hypertensive patients : first achievements]. [2019]

5. Austria pubmed.ncbi.nlm.nih.gov

[Hypertension short message service]. [2021]

6. United States 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. [2023]

7. China pubmed.ncbi.nlm.nih.gov

Management of arterial hypertension: home blood pressure measurement is a cornerstone for telemonitoring and self-management. [2023]

8. England pubmed.ncbi.nlm.nih.gov

A prospective pilot trial of the health data monitoring system without educational content for patients with hypertension. [2023]

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

The Retail Outlet Health Kiosk Hypertension Trial (ROKHYT): Pilot Results. [2022]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Home blood pressure measurement and digital health: communication technologies create a new context. [2019]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Post-intervention qualitative assessment of mobile health technology to manage hypertension among Ghanaian stroke survivors. [2023]

12. England pubmed.ncbi.nlm.nih.gov

Improving treatment adherence for blood pressure lowering via mobile phone SMS-messages in South Africa: a qualitative evaluation of the SMS-text Adherence SuppoRt (StAR) trial. [2022]