Clinical trial NCT03515681: Retail Outlet Health Kiosk Hypertension Trial
Official title: Retail Outlet Health Kiosk Hypertension Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Text messaging
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Higi
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2018-05-03
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators 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. Completion of these pilot studies will provide preliminary data to support an application for a full scale randomized controlled study. Potential for adaption is high because of alignment of retail outlets, kiosk providers, and consumers for health, wellness, and self-care.

Detailed description: 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 10,800 kiosks in the U.S. with 4,125 in Rite Aid pharmacies. More than 44 million BP measurements per year are obtained at higi kiosks. In the one-year period 7/1/15 to 6/30/16, approximately 727,000 individuals using higi kiosks recorded \>3 systolic BP measurements \>140/90 mmHg. The investigators propose to target this group using interactive text messaging to activate individuals to take actions to improve BP control. The primary endpoint will be BP control defined as \<140/90 mmHg at 12 months post randomization.

Eligibility criteria: Inclusion Criteria:

* \>3 systolic blood pressure measurements \>140/90 mmHg (two in the previous 12 months + one at baseline)
* Age 18-85 years
* Weight \<300 pounds
* Has a cell phone
* Can provide consent
* Speaks English or Spanish

Primary outcomes:
measure: Total Number of Participants With Blood Pressure Control at 12 Months
timeFrame: 12 months after randomization
Secondary outcomes:
measure: Total Number of Participants With Blood Pressure Control at 6 Months
timeFrame: 6 months
measure: Total Number of Participants With Blood Pressure Control at 3 Months
timeFrame: 3 months
measure: Mean Systolic Pressure at 12 Months
timeFrame: 12 months
measure: Mean Diastolic Pressure at 12 Months
timeFrame: 12 months
Other outcomes:
measure: Study Participation Rate
timeFrame: 2 weeks
measure: Study Completion Rate
timeFrame: 6 months
Locations:
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Steven Shea, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shea S, Thompson JLP, Schwartz JE, Chen Y, de Ferrante M, Vanderbeek AM, Buchsbaum R, Vargas C, Siddiqui KM, Moran AE, Stockwell M. The Retail Outlet Health Kiosk Hypertension Trial (ROKHYT): Pilot Results. Am J Hypertens. 2022 Jan 5;35(1):103-110. doi: 10.1093/ajh/hpab129.
citation: Palmer MJ, Machiyama K, Woodd S, Gubijev A, Barnard S, Russell S, Perel P, Free C. Mobile phone-based interventions for improving adherence to medication prescribed for the primary prevention of cardiovascular disease in adults. Cochrane Database Syst Rev. 2021 Mar 26;3(3):CD012675. doi: 10.1002/14651858.CD012675.pub3.