Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE April 23, 2018
First Posted Date  ICMJE May 3, 2018
Last Update Posted Date May 23, 2019
Actual Study Start Date  ICMJE March 6, 2019
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 23, 2018)
Blood pressure control at 12 months [ Time Frame: 12 months after randomization ]
Blood pressure <140/90 mmHg
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2018)
  • Blood pressure level [ Time Frame: 12 months ]
    Mean blood pressure in each group
  • Blood pressure control at 3 months [ Time Frame: 3 months ]
    Blood pressure <140/90 mmHg
  • Blood pressure control at 6 months [ Time Frame: 6 months ]
    Blood pressure <140/90 mmHg
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 23, 2018)
  • Study participation rate [ Time Frame: 2 weeks ]
    Proportion of those invited to participate who consent and are randomized
  • Study completion rate [ Time Frame: 12 months ]
    Proportion of those randomized who complete the study
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Retail Outlet Health Kiosk Hypertension Trial
Official Title  ICMJE Retail Outlet Health Kiosk Hypertension Trial
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hypertension
Intervention  ICMJE Behavioral: Text messages
Subjects randomized to intervention will receive text messages to promote seeking care and improving compliance with blood pressure treatment.
Study Arms  ICMJE
  • Experimental: Intervention
    Subjects randomized to intervention will receive text messages to promote seeking care and improving compliance with blood pressure treatment.
    Intervention: Behavioral: Text messages
  • 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).
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 23, 2018)
140
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2020
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Celibell Vargas 917-582-5542 cv2211@cumc.columbia.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03515681
Other Study ID Numbers  ICMJE AAAR3975
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Steven J. Shea, Columbia University
Study Sponsor  ICMJE Columbia University
Collaborators  ICMJE Higi SH IIc
Investigators  ICMJE
Principal Investigator: Steven Shea, MD, MS Columbia University
PRS Account Columbia University
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP