Retail Outlet Health Kiosk Hypertension Trial

NCT ID: NCT03515681

Last Updated: 2021-06-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-06
• Study Completion Date: 2020-07-30

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.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Intervention

Subjects randomized to intervention will receive text messages to promote seeking care and improving compliance with blood pressure treatment.

Group Type: EXPERIMENTAL

Text messages

Intervention Type: BEHAVIORAL

Subjects randomized to intervention will receive text messages to promote seeking care and improving compliance with blood pressure treatment.

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Text messages

Subjects randomized to intervention will receive text messages to promote seeking care and improving compliance with blood pressure treatment.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Higi

INDUSTRY

Sponsor Role: collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Steven J. Shea

Professor of Medicine and Epidemiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Steven Shea, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

Columbia University Medical Center

New York, New York, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 34382648 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33769555 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

5R34HL137659

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AAAR3975

Identifier Type: -

Identifier Source: org_study_id