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Retail Outlet Health Kiosk Hypertension Trial (ROKHyT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03515681
Recruitment Status : Recruiting
First Posted : May 3, 2018
Last Update Posted : May 23, 2019
Sponsor:
Collaborator:
Higi SH IIc
Information provided by (Responsible Party):
Steven J. Shea, Columbia University

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.

Condition or disease Intervention/treatment Phase
Hypertension Behavioral: Text messages Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Retail Outlet Health Kiosk Hypertension Trial
Actual Study Start Date : March 6, 2019
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine


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).



Primary Outcome Measures :
  1. Blood pressure control at 12 months [ Time Frame: 12 months after randomization ]
    Blood pressure <140/90 mmHg


Secondary Outcome Measures :
  1. Blood pressure level [ Time Frame: 12 months ]
    Mean blood pressure in each group

  2. Blood pressure control at 3 months [ Time Frame: 3 months ]
    Blood pressure <140/90 mmHg

  3. Blood pressure control at 6 months [ Time Frame: 6 months ]
    Blood pressure <140/90 mmHg


Other Outcome Measures:
  1. Study participation rate [ Time Frame: 2 weeks ]
    Proportion of those invited to participate who consent and are randomized

  2. Study completion rate [ Time Frame: 12 months ]
    Proportion of those randomized who complete the study



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03515681


Contacts
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Contact: Celibell Vargas 917-582-5542 cv2211@cumc.columbia.edu

Locations
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United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Celibell Vargas    917-582-5542    cv2211@cumc.columbia.edu   
Sub-Investigator: Melissa Stockwell, MD, MPH         
Sub-Investigator: John L. Thompson, PhD         
Sponsors and Collaborators
Columbia University
Higi SH IIc
Investigators
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Principal Investigator: Steven Shea, MD, MS Columbia University

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Responsible Party: Steven J. Shea, Professor of Medicine and Epidemiology, Columbia University
ClinicalTrials.gov Identifier: NCT03515681    
Other Study ID Numbers: AAAR3975
First Posted: May 3, 2018    Key Record Dates
Last Update Posted: May 23, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Steven J. Shea, Columbia University:
Text messaging
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases