NCT03515681: ROKHyT

Retail Outlet Health Kiosk Hypertension Trial

Completed NA Results posted Last updated 16 June 2021

What this trial tests

NA trial testing Text messages in Hypertension in 140 participants. Completed in 30 July 2020.

Timeline

6 March 2019

Primary endpoint
30 July 2020

30 July 2020

Quick facts

Lead sponsor	Columbia University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	140
Start date	6 March 2019
Primary completion	30 July 2020
Estimated completion	30 July 2020
Sites	1 location across United States

Drugs / interventions tested

• Text messages

Conditions studied

• Hypertension — all drugs for Hypertension →

Sponsor

Columbia University

Who can join

Adults 18 to 85, any sex, with Hypertension. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Total Number of Participants With Blood Pressure Control at 12 Months Primary · 12 months after randomization

Blood pressure (BP) control is defined as having BP \<140/90 mmHg.

Group	Value	95% CI
Intervention	13
Control	7

Total Number of Participants With Blood Pressure Control at 6 Months Secondary · 6 months

Blood pressure (BP) control is defined as having BP \<140/90 mmHg.

Group	Value	95% CI
Intervention	22
Control	19

Total Number of Participants With Blood Pressure Control at 3 Months Secondary · 3 months

Blood pressure (BP) control is defined as having BP \<140/90 mmHg.

Group	Value	95% CI
Intervention	24
Control	20

Mean Systolic Pressure at 12 Months Secondary · 12 months

Mean systolic blood pressure measurement at 12 months from randomization.

Group	Value	95% CI
Intervention	141.2	± 17.91
Control	147.0	± 19.65

Study Participation Rate Secondary · 2 weeks

Proportion of those invited to participate who consent and are randomized.

Group	Value	95% CI
Intervention	70
Control	70

Study Completion Rate Secondary · 6 months

Proportion of those randomized who completed follow up at month 6.

Group	Value	95% CI
Intervention	61
Control	62

Mean Diastolic Pressure at 12 Months Secondary · 12 months

Mean diastolic blood pressure measurement at 12 months from randomization.

Group	Value	95% CI
Intervention	88.0	± 11.90
Control	88.8	± 12.73

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Mobile phone-based interventions for improving adherence to medication prescribed for the primary prevention of cardiovascular disease in adults.
   Palmer MJ, Machiyama K, Woodd S, Gubijev A, et al · · 2021 · cited 25× · PMID 33769555 · DOI 10.1002/14651858.cd012675.pub3
2. The Retail Outlet Health Kiosk Hypertension Trial (ROKHYT): Pilot Results.
   Shea S, Thompson JLP, Schwartz JE, Chen Y, et al · · 2022 · cited 8× · PMID 34382648 · DOI 10.1093/ajh/hpab129