NCT03515681

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 3, 2018

Completed
10 months until next milestone

Study Start

First participant enrolled

March 6, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2020

Completed
6 months until next milestone

Results Posted

Study results publicly available

January 11, 2021

Completed
Last Updated

June 16, 2021

Status Verified

May 1, 2021

Enrollment Period

1.4 years

First QC Date

April 23, 2018

Results QC Date

November 20, 2020

Last Update Submit

May 27, 2021

Conditions

Hypertension

Keywords

Text messaging

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Total Number of Participants With Blood Pressure Control at 6 Months

    6 months

  • Total Number of Participants With Blood Pressure Control at 3 Months

    3 months

  • Mean Systolic Pressure at 12 Months

    12 months

  • Mean Diastolic Pressure at 12 Months

    12 months

Other Outcomes (2)

  • Study Participation Rate

    2 weeks

  • Study Completion Rate

    6 months

Study Arms (2)

Intervention

EXPERIMENTAL

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

Behavioral: Text messages

Control

NO INTERVENTION

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).

Interventions

Text messagesBEHAVIORAL

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

Intervention

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \>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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

Related Publications (2)

  • 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.

    PMID: 34382648DERIVED

  • 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.

    PMID: 33769555DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Results Point of Contact

Title
Steven J. Shea, MD
Organization
Columbia University
ss35@cumc.columbia.edu
212-305-6355

Study Officials

  • Steven Shea, MD, MS

    Columbia University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Medicine and Epidemiology

Study Record Dates

First Submitted

April 23, 2018

First Posted

May 3, 2018

Study Start

March 6, 2019

Primary Completion

July 30, 2020

Study Completion

July 30, 2020

Last Updated

June 16, 2021

Results First Posted

January 11, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)