Retail Outlet Health Kiosk Hypertension Trial

Study Overview
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Brief Summary
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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
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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.

Official Title
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Retail Outlet Health Kiosk Hypertension Trial

Conditions
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Hypertension

Intervention / Treatment
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* Behavioral: Text messages


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Subjects randomized to intervention will receive text messages to promote seeking care and improving compliance with blood pressure treatment. | Behavioral: Text messages<br>* Subjects randomized to intervention will receive text messages to promote seeking care and improving compliance with blood pressure treatment.<br>|
| No Intervention: Control<br>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?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Text messaging