Bloomer Tech is advancing development of the Bloomer Augmented Garment Platform, a wearable bra with embedded sensors to address cardiovascular healthcare disparities in women. Cardiovascular disease is the leading cause of death in women, resulting in nearly 315,000 deaths in the U.S. in 2020, where women generally experience worse outcomes than men including increased disability, hospitalization, and earlier mortality. Cardiac rehabilitation (CR) is strongly recommended by the American Heart Association and the American College of Cardiology for a variety of indications based on evidence for reduced mortality and morbidity and increased quality of life. Unfortunately, only ~15% to 20% of eligible women participate in this life saving program, compared to 22% to 30% of men. Critically, barriers to participation may differ between women and men and different interventions may therefore be required to increase adherence. Research suggests that supporting women through expanded access to safe, remote access of CR-related exercise routines holds significant potential to improve adherence and broadly improve cardiovascular outcomes in women. Specifically for women, there is an opportunity to increase adherence by catalyzing their motivation and increasing frequency of reinforcing conditions that provide reassurance, supervision, and validation to her achievements in the program and support her adherence within the care continuum. A continuous remote sensing platform that women felt safe and comfortable in holds significant potential to promote adoption and adherence to CR. To address this need, Bloomer Tech has developed the Bloomer Augmented Garment Platform, a female bra with embedded textile sensors that are washable and designed specifically for collecting cardiac biomarker information from women. Bloomer Tech has demonstrated Phase I equivalent proof-of-concept by creating an MVP software platform, establishing device manufacturing best practices, and demonstrating reproducible sensor signal quality in a variety of different bra sizes necessary for continuous monitoring. The goal of this project will be to demonstrate that the Bloomer Tech Platform increases adherence to CR compared to the current standard of care through a robust randomized clinical trial in women prescribed CR at the University of Florida Medical Center and Lakeland Regional Health in Florida. Furthermore, the trial will assess overall participant perception of safety and comfort using the Bloomer Tech bra. Success with these goals will support commercial adoption by both clinicians and patients by demonstrating that patients can safely and comfortably participate in CR both in the clinic and during at-home exercises that are not directly supervised by a clinician.
Public Health Relevance Statement: PROJECT NARRATIVE Cardiac rehabilitation is strongly recommended following a variety of cardiovascular disease complications for evidence of reduced mortality, morbidity, and increased quality of life, but it is underutilized, especially in women, where barriers to increase adherence to cardiac rehabilitation are different for men and women. Bloomer Tech is advancing development of the Bloomer Augmented Garment (AG), a cardiac biomarker-based remote- monitoring platform designed for optimal fit and performance in women. Here, Bloomer Tech will complete a clinical trial to demonstrate that the Bloomer AG platform increases adherence to cardiac rehabilitation over the standard of care toward improved health outcomes and reduced healthcare disparities in women.
Project Terms: Achievement Attainment; Achievement; Activities of everyday life; daily living function; daily living functionality; functional ability; functional capacity; Activities of Daily Living; Adhesives; Adoption; 21+ years old; Adult Human; adulthood; Adult; American Heart Association; Cardiology; Cardiovascular Diseases; cardiovascular disorder; Cardiovascular system; Cardiovascular; Cardiovascular Body System; Cardiovascular Organ System; Heart Vascular; circulatory system; Cause of Death; Clinical Trials; Continuity of Patient Care; Continuity of Care; Continuum of Care; Control Groups; Cessation of life; Death; Electrocardiogram; ECG; EKG; Electrocardiography; Electrodes; Eligibility Determination; Eligibility; Protocol Screening; Exercise; Face; faces; facial; Female; Florida; Goals; Health; Heart Diseases; Cardiac Diseases; Cardiac Disorders; heart disorder; Hospitalization; Hospital Admission; indexing; Lead; Pb element; heavy metal Pb; heavy metal lead; men; Morbidity - disease rate; Morbidity; mortality; Motivation; Movement; body movement; Patients; Perception; Posture; Quality of life; QOL; Recommendation; Research; Role; social role; Safety; Signal Transduction; Cell Communication and Signaling; Cell Signaling; Intracellular Communication and Signaling; Signal Transduction Systems; Signaling; biological signal transduction; Skin Temperature; Computer software; Software; Supervision; Surveys; Survey Instrument; Testing; Textiles; fabric; Transportation; Universities; Woman; Wrist; Measures; falls; Device Designs; Family Care Giver; Family Caregiver; sensor; improved; Clinical; Phase; Medical; randomized, clinical trials; Ensure; disability; Visual; analog; Funding; Shapes; Life; programs; Frequencies; Clinic; Location; college; collegiate; Medical center; American; experience; monitoring device; Performance; success; remote sensing; participatory sensing; Participant; Devices; Reporting; Excision; Abscission; Extirpation; Removal; Surgical Removal; resection; Adverse event; Adverse Experience; Intervention; Intervention Strategies; interventional strategy; Provider; disparity in health; health disparity; Address; Health system; Adherence; Reproducibility; Validation; validations; Monitor; Mammary Gland Parenchyma; Breast Tissue; Mammary Gland Tissue; Cardiac; open label; open label study; Advanced Development; designing; design; clinical site; clinical research site; Outcome; prospective; innovate; innovative; innovation; usability; commercialization; group intervention; patient population; standard of care; bio-markers; biologic marker; biomarker; Biological Markers; Secure; cardiac rehab; Cardiac rehabilitation; mobile app; mobile device application; mobile application; cardiovascular health; heart rate monitor; accelerometry; activity monitor; activity tracker; Accelerometer; Exercise routine; exercise regimen; Prescribed exercise; exercise prescription; disparity in care; disparity in healthcare; health care inequality; health care inequity; healthcare disparity; healthcare inequality; healthcare inequity; health care disparity; smartwatch; smart watch; body sensor; body worn sensor; wearable biosensor; wearable sensor; wearable sensor technology; intervention arm; treatment arm; secondary end point; secondary endpoint; primary end point; primary endpoint; adherence rate; Differences between sexes; Differs between sexes; Sexual differences; sex-dependent differences; sex-related differences; sex-specific differences; Sex Differences; adoption by clinician; adoption by healthcare providers; adoption by physician; adoption by provider; clinician adoption; physician adoption; provider-level adoption; provider adoption; remote monitoring; homes; Home; comparison control; compare to control; manufacture; Digital biomarker; digital marker
