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N/A N=140 Randomized Double-blind Treatment

Retail Outlet Health Kiosk Hypertension Trial

Hypertension

Enrolled (actual)
140
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcome: Primary: Total Number of Participants With Blood Pressure Control at 12 Months — 13; 7 Participants

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Text messages (Behavioral)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Columbia University
Primary completion
Jul 2020

Outcome Measures

OutcomeResultp-value
PRIMARY
Total Number of Participants With Blood Pressure Control at 12 Months
13; 7
SECONDARY
Total Number of Participants With Blood Pressure Control at 6 Months
22; 19
SECONDARY
Total Number of Participants With Blood Pressure Control at 3 Months
24; 20
SECONDARY
Mean Systolic Pressure at 12 Months
141.2; 147.0
SECONDARY
Mean Diastolic Pressure at 12 Months
88.0; 88.8

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.

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03515681). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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