Portable Air Cleaners for High Blood Pressure
(AirPressureNYC Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: NYU Langone Health
Disqualifiers: Arrhythmias, Severe hypertension, Cardiovascular disease, others
No Placebo Group
Trial Summary
What is the purpose of this trial?Fine particulate matter \<2.5 µm (PM2.5) air pollution is the fifth leading risk factor for global mortality, with the largest portion of deaths due to cardiovascular disease (CVD). While several mechanisms are responsible, PM2.5-induced elevations in blood pressure (BP) may be relevant. Indoor portable air cleaners (PACs) are a novel approach to reduce exposure to PM2.5 and potentially lower blood pressure. The current study is being conducted to provide evidence that PACs reduce PM2.5 exposure and lower systolic blood pressure (SBP) in key patient populations.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you plan to change your drug regimen during the first 30 days of the trial.
How does the treatment 'Portable Air Cleaners' for high blood pressure differ from other treatments?
Portable air cleaners are unique because they focus on improving indoor air quality to help manage high blood pressure, unlike traditional treatments that typically involve medication or lifestyle changes. This approach is novel as it targets environmental factors that may contribute to high blood pressure, rather than directly altering the body's physiological processes.
12345Eligibility Criteria
This trial is for non-smoking adults with hypertension living in NYC public housing who don't have severe high blood pressure, major arrhythmias, cardiovascular disease, lung disease requiring oxygen, end-stage renal disease or cancer under treatment. They shouldn't plan to travel out of NYC for long periods or change their medication soon.Inclusion Criteria
You do not smoke and live with people who do not smoke.
This criterion includes adults who have high blood pressure and live in public housing in New York City.
Exclusion Criteria
I haven't changed my blood pressure medication in the last 2 weeks and don't plan to change it in the next 30 days.
I need oxygen for my lung condition.
I have a history of serious heart rhythm problems.
+10 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Baseline
Initiation of PAC devices and monitoring setup
1 day
1 visit (in-person)
Treatment
Participants use PACs in their bedrooms for 30 days to reduce PM2.5 exposure
30 days
Daily self-monitoring
Follow-up
Participants are monitored for changes in blood pressure over an extended period
180 days
Self-monitoring and periodic check-ins
Participant Groups
The study tests if portable air cleaners (PACs) can reduce indoor fine particulate matter and lower systolic blood pressure. Participants will be randomly assigned to use either an active PAC that filters the air or a sham PAC that does not work but looks identical.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active Portable Air Cleaner (PAC)Experimental Treatment1 Intervention
Using a double-blind randomized process, active PACs (with HEPA filters inside) will be assembled and placed in the bedroom of study participants. Initiation of the PAC devices will occur at baseline on Day 0. After completion of enrollment, consent and the placement of PACs, electricity monitors, and PurpleAir monitoring, the PAC will be turned on. Participants will be instructed to keep the PACs on in bedrooms during the study duration, closing bedroom doors at night and during the day, when possible. The PAC will run for 24 hours on Day 0 of the study protocol before the 30-day treatment period begins. A kilowatt meter will be installed with the PAC to monitor electricity usage as a measure of adherence.
Group II: Sham PACPlacebo Group1 Intervention
Using a double-blind randomized process, sham PACs (with no filters inside) will be assembled and placed in the bedroom of study participants. Initiation of the PAC devices will occur at baseline on Day 0. After completion of enrollment, consent and the placement of PACs, electricity monitors, and PurpleAir monitoring, the PAC will be turned on. Participants will be instructed to keep PACs on in bedrooms during the study duration, closing bedroom doors at night and during the day, when possible. The PAC will run for 24 hours on Day 0 of the study protocol before the 30-day treatment period begins. A kilowatt meter will be installed with the PAC to monitor electricity usage as a measure of adherence.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
NYU Langone HealthNew York, NY
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Who Is Running the Clinical Trial?
NYU Langone HealthLead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)Collaborator
References
Piloting a Faith-Based Hypertension Self-Care Program in a Church Setting. [2023]Health promotion strategies offered in a faith-based setting can be effective in influencing positive self-care behaviors related to hypertension. Faith-based organizations are ideal places to reach vulnerable populations to improve blood pressure management and make a lasting impact. The purpose of this pilot study was to provide a 4-week management program to improve hypertension self-care among a congregation of African Americans. Results revealed improvements among participants related to self-care as well as lowered blood pressure readings.
Self-measurement of blood pressure: assessment of equipment. Canadian Coalition for High Blood Pressure Prevention and Control. [2008]Equipment for the self-measurement of blood pressure is readily available to consumers. These devices use one or more surrogate (indirect) measures of pressure to estimate systolic and diastolic blood pressure. Manual auscultatory devices using stethoscope and sphygmomanometer have been adapted for home use, but a variety of automated devices based on auscultation, oscillometry, and other techniques are available and may be more suitable for individuals who have limited vision, hearing or dexterity. Despite the existence of voluntary evaluation protocols and mandatory manufacturing standards, blood pressure readings from some automatic devices may not be accurate. Some devices are packaged with insufficient information to ensure proper use, and most individuals need some form of guidance in their use and calibration testing. If self-measurement of blood pressure is to be of benefit, the health care professional must recommend only those devices that are accurate and suitable to the patient or client. The Canadian Coalition for High Blood Pressure Prevention and Control will endeavour to develop a regular means by which health care professionals can keep informed of available devices for blood pressure self-measurement.
Preventive health services: High blood pressure control. [2008]An estimated 60 million Americans have high blood pressure that increases their risk of illness and premature death. Of these persons approximately 35 million need some form of continuing treatment, while the remaining 25 million have borderline high blood pressure that requires medical surveillance. Untreated hypertension is the largest single contributor to stroke and a major contributor to heart disease and kidney failure. The National High Blood Pressure Education Program, started in 1972, has helped to improve hypertension control in the Nation. With providers and the public better informed about hypertension, patient visits and medication prescriptions for hypertension have increased, as has the number of persons whose hypertension is well controlled. Associated deaths, especially from stroke, have declined rapidly and dramatically. There is much room for improvement. Provider interest in and attention to long-term regimen adherence needs more emphasis. Large segments of the population, especially ethnic and racial minority groups, continue to face access problems. Awareness and attempted application of patient management technologies have improved, but stronger efforts are needed to address care delivery system management issues.
Healthcare provider's perspectives on home blood pressure management in Peru and Cameroon: Findings from the BPMONITOR study. [2023]Home blood pressure management, including self-monitoring and medication self-titration, is an efficient and cost-effective tool. Although its use is increasing globally, little is known about the feasibility of such interventions in low and middle-income countries. Further, the perspectives and experiences of healthcare providers who play a big role in ensuring the success of home blood pressure management interventions have not been documented. This qualitative study was conducted with a total of 35 healthcare providers (60% female, mean [SD] age = 37.3 [6.9 years] years), through 4 in-depth interviews from Peru, and 8 in-depth interviews and 4 focus groups from Cameroon. Study participants (healthcare providers) include physicians (primary care physicians), specialists (cardiologists and geriatricians), and nurses that were purposively recruited from two hospitals in two of the largest cities in both countries. Results were thematically analyzed by two researchers. Themes derived were related to feasibility and acceptability, and largely reflected providers in both countries endorsing home blood pressure management. Providers' concerns were in three main areas; 1) safety of patients when they self-titrate medications, 2) resources such as healthcare financing, local hospital policies that support communications with patients for home blood pressure management, and 3) sustainability through patient adherence, incorporating home blood pressure management within clinical guidelines and hospital policies, and complementing with continued health education and lifestyle modifications. According to providers, home blood pressure management may be feasible and acceptable if tailored multi-faceted protocols were introduced bearing in mind local contexts.
Implementation and barriers to uptake of interactive voice response technology aimed to improve blood pressure control at a large academic medical center. [2020]Blood pressure control among patients with hypertension is a widely recognized quality metric, but many large health systems fail to reach targets set by the Healthcare Effectiveness Data and Information Set. We developed an interactive voice response (IVR) system called the "Mobile You Blood Pressure Program" at a large academic medical center and linked it to the health system's electronic health record (EHR). The goal of the program was to capture home blood pressure readings in the EHR and to alert ambulatory care clinical pharmacists automatically of readings below or above clinical thresholds through direct messaging in the EHR. The goal of this report is to describe implementation of IVR, initial patient participation rates, and pharmacist-identified barriers to patient enrollment.