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Retail Outlet Health Kiosk Hypertension Trial

Retail Outlet Health Kiosk Hypertension Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03515681
Acronym
ROKHyT
Enrollment
140
Registered
2018-05-03
Start date
2019-03-06
Completion date
2020-07-30
Last updated
2021-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

Text messaging

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.

Interventions

BEHAVIORALText messages

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

Sponsors

Higi
CollaboratorINDUSTRY
National Heart, Lung, and Blood Institute (NHLBI)
CollaboratorNIH
Columbia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Total Number of Participants With Blood Pressure Control at 12 Months12 months after randomizationBlood pressure (BP) control is defined as having BP \<140/90 mmHg.

Secondary

MeasureTime frameDescription
Total Number of Participants With Blood Pressure Control at 6 Months6 monthsBlood pressure (BP) control is defined as having BP \<140/90 mmHg.
Total Number of Participants With Blood Pressure Control at 3 Months3 monthsBlood pressure (BP) control is defined as having BP \<140/90 mmHg.
Mean Systolic Pressure at 12 Months12 monthsMean systolic blood pressure measurement at 12 months from randomization.
Mean Diastolic Pressure at 12 Months12 monthsMean diastolic blood pressure measurement at 12 months from randomization.

Other

MeasureTime frameDescription
Study Participation Rate2 weeksProportion of those invited to participate who consent and are randomized.
Study Completion Rate6 monthsProportion of those randomized who completed follow up at month 6.

Countries

United States

Participant flow

Participants by arm

ArmCount
Intervention
Subjects randomized to intervention will receive text messages to promote seeking care and improving compliance with blood pressure treatment. Text messages: Subjects randomized to intervention will receive text messages to promote seeking care and improving compliance with blood pressure treatment.
70
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).
70
Total140

Baseline characteristics

CharacteristicTotalControlIntervention
Age, Continuous52.1 years
STANDARD_DEVIATION 11.7
51.4 years
STANDARD_DEVIATION 11.2
52.8 years
STANDARD_DEVIATION 12.2
Ethnicity (NIH/OMB)
Hispanic or Latino
17 Participants9 Participants8 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
119 Participants58 Participants61 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
4 Participants3 Participants1 Participants
Mean diastolic blood pressure91.8 mm Hg
STANDARD_DEVIATION 12.4
91.3 mm Hg
STANDARD_DEVIATION 12.7
92.2 mm Hg
STANDARD_DEVIATION 12.2
Mean systolic blood pressure145.5 mm Hg
STANDARD_DEVIATION 18.9
144.4 mm Hg
STANDARD_DEVIATION 17
146.7 mm Hg
STANDARD_DEVIATION 20.6
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
7 Participants3 Participants4 Participants
Race (NIH/OMB)
Black or African American
17 Participants8 Participants9 Participants
Race (NIH/OMB)
More than one race
4 Participants2 Participants2 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
13 Participants9 Participants4 Participants
Race (NIH/OMB)
White
99 Participants48 Participants51 Participants
Sex: Female, Male
Female
67 Participants33 Participants34 Participants
Sex: Female, Male
Male
73 Participants37 Participants36 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 700 / 70
other
Total, other adverse events
0 / 700 / 70
serious
Total, serious adverse events
0 / 700 / 70

Outcome results

Primary

Total Number of Participants With Blood Pressure Control at 12 Months

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

Time frame: 12 months after randomization

Population: Only includes individuals who completed the study at 12 months.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
InterventionTotal Number of Participants With Blood Pressure Control at 12 Months13 Participants
ControlTotal Number of Participants With Blood Pressure Control at 12 Months7 Participants
Secondary

Mean Diastolic Pressure at 12 Months

Mean diastolic blood pressure measurement at 12 months from randomization.

Time frame: 12 months

Population: Only includes individuals who completed the study at 12 months

ArmMeasureValue (MEAN)Dispersion
InterventionMean Diastolic Pressure at 12 Months88.0 mm HgStandard Deviation 11.9
ControlMean Diastolic Pressure at 12 Months88.8 mm HgStandard Deviation 12.73
Secondary

Mean Systolic Pressure at 12 Months

Mean systolic blood pressure measurement at 12 months from randomization.

Time frame: 12 months

Population: Only includes participants who completed the study at 12 months.

ArmMeasureValue (MEAN)Dispersion
InterventionMean Systolic Pressure at 12 Months141.2 mm HgStandard Deviation 17.91
ControlMean Systolic Pressure at 12 Months147.0 mm HgStandard Deviation 19.65
Secondary

Total Number of Participants With Blood Pressure Control at 3 Months

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

Time frame: 3 months

Population: Only includes participants who completed the study at 3 months.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
InterventionTotal Number of Participants With Blood Pressure Control at 3 Months24 Participants
ControlTotal Number of Participants With Blood Pressure Control at 3 Months20 Participants
Secondary

Total Number of Participants With Blood Pressure Control at 6 Months

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

Time frame: 6 months

Population: Only includes participants who completed the study at 6 months.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
InterventionTotal Number of Participants With Blood Pressure Control at 6 Months22 Participants
ControlTotal Number of Participants With Blood Pressure Control at 6 Months19 Participants
Other Pre-specified

Study Completion Rate

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

Time frame: 6 months

Population: Only includes randomize participants.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
InterventionStudy Completion Rate61 Participants
ControlStudy Completion Rate62 Participants
Other Pre-specified

Study Participation Rate

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

Time frame: 2 weeks

Population: Includes all consented individuals.

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
InterventionStudy Participation Rate70 Participants
ControlStudy Participation Rate70 Participants

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026