Cardiovascular disease (CVD) remains the leading cause of death in the U.S. as well as the leading cause of health care cost. Hypertension is the leading remediable risk factor for CVD in the U.S. and globally, with prevalence of 29% in U.S. adults. Recent data from NHANES indicate that blood pressure (BP) is not controlled, defined as <140/90 mmHg, in 48% of individuals in the U.S. with hypertension. Strategies to improve hypertension control have focused on the physician-patient interaction at the office visit, system factors in the health care provider system, and extension beyond the traditionally defined health care system. All have had some success but are limited by not reaching individuals outside the clinical encounter or by challenges of scale, scope, and standardization of blood pressure measurement outside the clinical setting. Retail outlet BP devices have the potential to address these limitations by providing free BP measurements to individuals outside the clinical setting and at all times the retail outlet is open. These automated devices are standardized and linked to software with the ability to collect data and provide information to individuals using these devices, thereby providing a platform for an intervention strategy. Higi is a privately owned company that provides health kiosks in retail outlets. Higi presently has 11,588 kiosks in the U.S. with 4,125 in Rite Aid pharmacies. More than 45 million BP measurements per year are obtained at higi kiosks. In the one-year period 1/1/16 to 12/3`/16, approximately 830,700 individuals using higi kiosks recorded >3 systolic BP measurements >140/90 mmHg. We propose to target this group using interactive text messaging to activate individuals to take actions to improve BP control. The pilot studies proposed here will provide preliminary data to support an application to conduct a fully powered randomized trial comparing a tailored text messaging intervention to usual care. The primary endpoint will be BP control defined as <140/90 mmHg at 12 months post randomization. We propose to conduct a pilot study with the following specific aims: (1) Develop and pre-test the intervention text messages; (2) Pilot enrollment, consent, randomization, and data collection procedures at baseline, 3, 6, and 12 months; document participation and completion rates in a pilot study of N=70/group; (3) Obtain demographic data on potentially eligible participants using an on-line questionnaire; (4) Pilot the text messaging intervention; document BP control rate in response to intervention; and (5) Pilot test secure data transfer and other data coordinating center functions. Potential for adaption is high because of alignment of retail outlets, kiosk providers, and consumers for health, wellness, and self-care.
We propose to conduct pilot studies to support an application to conduct a fully powered randomized trial of a text messaging intervention to increase the rate of blood pressure control, defined as <140/90 mmHg, among hypertensive individuals using health kiosk blood pressure devices. These pilot studies will include testing of the intervention, recruitment, enrollment, and data collection procedures, and of the web-based interactions between the data coordinating center and higi SH llc (Chicago, IL), which is the company that installs and maintains the health care kiosks and associated software infrastructure.
