Trial Outcomes & Findings for Retail Outlet Health Kiosk Hypertension Trial (NCT NCT03515681)
NCT ID: NCT03515681
Last Updated: 2021-06-16
Results Overview
Blood pressure (BP) control is defined as having BP \<140/90 mmHg.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
140 participants
Primary outcome timeframe
12 months after randomization
Results posted on
2021-06-16
Participant Flow
Participant milestones
| Measure |
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.
|
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).
|
|---|---|---|
|
Overall Study
STARTED
|
70
|
70
|
|
Overall Study
Randomized
|
70
|
70
|
|
Overall Study
Completed at 6 Months
|
61
|
62
|
|
Overall Study
COMPLETED
|
37
|
25
|
|
Overall Study
NOT COMPLETED
|
33
|
45
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Retail Outlet Health Kiosk Hypertension Trial
Baseline characteristics by cohort
| Measure |
Intervention
n=70 Participants
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.
|
Control
n=70 Participants
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).
|
Total
n=140 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.8 years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
51.4 years
STANDARD_DEVIATION 11.2 • n=7 Participants
|
52.1 years
STANDARD_DEVIATION 11.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
34 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
61 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
119 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
51 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
99 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Mean systolic blood pressure
|
146.7 mm Hg
STANDARD_DEVIATION 20.6 • n=5 Participants
|
144.4 mm Hg
STANDARD_DEVIATION 17.0 • n=7 Participants
|
145.5 mm Hg
STANDARD_DEVIATION 18.9 • n=5 Participants
|
|
Mean diastolic blood pressure
|
92.2 mm Hg
STANDARD_DEVIATION 12.2 • n=5 Participants
|
91.3 mm Hg
STANDARD_DEVIATION 12.7 • n=7 Participants
|
91.8 mm Hg
STANDARD_DEVIATION 12.4 • n=5 Participants
|
PRIMARY outcome
Timeframe: 12 months after randomizationPopulation: Only includes individuals who completed the study at 12 months.
Blood pressure (BP) control is defined as having BP \<140/90 mmHg.
Outcome measures
| Measure |
Intervention
n=37 Participants
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.
|
Control
n=25 Participants
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).
|
|---|---|---|
|
Total Number of Participants With Blood Pressure Control at 12 Months
|
13 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Only includes participants who completed the study at 6 months.
Blood pressure (BP) control is defined as having BP \<140/90 mmHg.
Outcome measures
| Measure |
Intervention
n=61 Participants
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.
|
Control
n=62 Participants
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).
|
|---|---|---|
|
Total Number of Participants With Blood Pressure Control at 6 Months
|
22 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Only includes participants who completed the study at 3 months.
Blood pressure (BP) control is defined as having BP \<140/90 mmHg.
Outcome measures
| Measure |
Intervention
n=67 Participants
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.
|
Control
n=64 Participants
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).
|
|---|---|---|
|
Total Number of Participants With Blood Pressure Control at 3 Months
|
24 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Only includes participants who completed the study at 12 months.
Mean systolic blood pressure measurement at 12 months from randomization.
Outcome measures
| Measure |
Intervention
n=37 Participants
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.
|
Control
n=25 Participants
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).
|
|---|---|---|
|
Mean Systolic Pressure at 12 Months
|
141.2 mm Hg
Standard Deviation 17.91
|
147.0 mm Hg
Standard Deviation 19.65
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Only includes individuals who completed the study at 12 months
Mean diastolic blood pressure measurement at 12 months from randomization.
Outcome measures
| Measure |
Intervention
n=37 Participants
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.
|
Control
n=25 Participants
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).
|
|---|---|---|
|
Mean Diastolic Pressure at 12 Months
|
88.0 mm Hg
Standard Deviation 11.90
|
88.8 mm Hg
Standard Deviation 12.73
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 2 weeksPopulation: Includes all consented individuals.
Proportion of those invited to participate who consent and are randomized.
Outcome measures
| Measure |
Intervention
n=78 Participants
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.
|
Control
n=72 Participants
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).
|
|---|---|---|
|
Study Participation Rate
|
70 Participants
|
70 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsPopulation: Only includes randomize participants.
Proportion of those randomized who completed follow up at month 6.
Outcome measures
| Measure |
Intervention
n=70 Participants
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.
|
Control
n=70 Participants
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).
|
|---|---|---|
|
Study Completion Rate
|
61 Participants
|
62 Participants
|
Adverse Events
Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place