Retail Outlet Health Kiosk Hypertension Trial (ROKHyT)

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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Behavioral: Text messages

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.

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Subjects randomized to intervention will receive text messages to promote seeking care and improving compliance with blood pressure treatment.	Behavioral: Text messages; Subjects randomized to intervention will receive text messages to promote seeking care and improving compliance with blood pressure treatment.
No Intervention: Control; Subjects randomized to the control arm will receive the messages regarding their kiosk blood pressure levels currently provided by higi to kiosk users. These messages are provided at the kiosk at the time of the blood pressure measurement (no text messages).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Number of Participants With Blood Pressure Control at 12 Months	Blood pressure (BP) control is defined as having BP <140/90 mmHg.	12 months after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Number of Participants With Blood Pressure Control at 6 Months	Blood pressure (BP) control is defined as having BP <140/90 mmHg.	6 months
Total Number of Participants With Blood Pressure Control at 3 Months	Blood pressure (BP) control is defined as having BP <140/90 mmHg.	3 months
Mean Systolic Pressure at 12 Months	Mean systolic blood pressure measurement at 12 months from randomization.	12 months
Mean Diastolic Pressure at 12 Months	Mean diastolic blood pressure measurement at 12 months from randomization.	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Study Participation Rate	Proportion of those invited to participate who consent and are randomized.	2 weeks
Study Completion Rate	Proportion of those randomized who completed follow up at month 6.	6 months

Collaborators and Investigators

• Sponsor: Columbia University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); Higi SH IIc
• Investigators: Principal Investigator: Steven Shea, MD, MS, Columbia University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2019
• Primary Completion (Actual): July 30, 2020
• Study Completion (Actual): July 30, 2020

Study Registration Dates

• First Submitted: April 23, 2018
• First Submitted That Met QC Criteria: April 23, 2018
• First Posted (Actual): May 3, 2018

Study Record Updates

• Last Update Posted (Actual): June 16, 2021
• Last Update Submitted That Met QC Criteria: May 27, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Text messaging
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: AAAR3975; 5R34HL137659 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No