Trial Outcomes & Findings for Patient Centered Health Technology Medication Adherence Program for African American Hypertensives (NCT NCT03454308)
NCT ID: NCT03454308
Last Updated: 2025-06-13
Results Overview
Percent of subjects meeting JNC8 Guidelines for BP control (\<140/90)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
204 participants
Primary outcome timeframe
at 6 months at the end of intervention
Results posted on
2025-06-13
Participant Flow
We will use 8 practice sites in each arm RCT design with clinic as unit of randomization and patient as unit of analysis.
Unit of analysis: clinical site
Participant milestones
| Measure |
SMASH
Automated reminder functions activated on pill monitoring device, motivational text messages, at home BP monitoring
SMASH Arm: Auditory and visual reminders are active on Pill device will alert subject each time their medication dose is due. Pill device will transmit dose taken time stamps to researchers. Text message the following morning with tailored motivational messages that reflect the medication dose adherence from the preceding day. Subjects will monitor their BP at home at least every third day using Bluetooth monitor linked to smartphone to transmit encrypted readings to researchers.
|
Enhanced SC
No reminder functions on the pill monitoring device, attention control text messages
Enhanced SC Arm: Auditory and visual reminders are inactive on Pill device. Pill device will transmit dose taken times to researchers. Healthy lifestyle test messages as attention control.
|
|---|---|---|
|
Overall Study
STARTED
|
97 4
|
107 4
|
|
Overall Study
COMPLETED
|
97 4
|
107 4
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Patient Centered Health Technology Medication Adherence Program for African American Hypertensives
Baseline characteristics by cohort
| Measure |
SMASH
n=97 Participants
Automated reminder functions activated on pill monitoring device, motivational text messages, at home BP monitoring
SMASH: Auditory and visual reminders are active on Pill device will alert subject each time their medication dose is due. Pill device will transmit dose taken time stamps to researchers. Text message the following morning with tailored motivational messages that reflect the medication dose adherence from the preceding day. Subjects will monitor their BP at home at least every third day using Bluetooth monitor linked to smartphone to transmit encrypted readings to researchers.
|
Enhanced SC
n=107 Participants
No reminder functions on the pill monitoring device, attention control text messages
Enhanced SC: Auditory and visual reminders are inactive on Pill device. Pill device will transmit dose taken times to researchers. Healthy lifestyle test messages as attention control.
|
Total
n=204 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
97 Participants
n=93 Participants
|
107 Participants
n=4 Participants
|
204 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Continuous
|
50.0 years
STANDARD_DEVIATION 9.3 • n=93 Participants
|
47.0 years
STANDARD_DEVIATION 9.7 • n=4 Participants
|
48.4 years
STANDARD_DEVIATION 9.6 • n=27 Participants
|
|
Sex: Female, Male
Female
|
65 Participants
n=93 Participants
|
74 Participants
n=4 Participants
|
139 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=93 Participants
|
33 Participants
n=4 Participants
|
65 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
97 Participants
n=93 Participants
|
107 Participants
n=4 Participants
|
204 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
97 Participants
n=93 Participants
|
107 Participants
n=4 Participants
|
204 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
97 participants
n=93 Participants
|
107 participants
n=4 Participants
|
204 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: at 6 months at the end of interventionPercent of subjects meeting JNC8 Guidelines for BP control (\<140/90)
Outcome measures
| Measure |
SMASH
n=97 Participants
Automated reminder functions activated on pill monitoring device, motivational text messages, at home BP monitoring
SMASH: Auditory and visual reminders are active on Pill device will alert subject each time their medication dose is due. Pill device will transmit dose taken time stamps to researchers. Text message the following morning with tailored motivational messages that reflect the medication dose adherence from the preceding day. Subjects will monitor their BP at home at least every third day using Bluetooth monitor linked to smartphone to transmit encrypted readings to researchers.
|
Enhanced SC
n=106 Participants
No reminder functions on the pill monitoring device, attention control text messages
Enhanced SC: Auditory and visual reminders are inactive on Pill device. Pill device will transmit dose taken times to researchers. Healthy lifestyle test messages as attention control.
|
|---|---|---|
|
Percent of Subjects Meeting JNC8 Guidelines for BP Control
|
97 Participants
|
106 Participants
|
PRIMARY outcome
Timeframe: Average across 6 mos.of interventionMedication adherence \>.90 using electronic medication intake devices. An algorithm is used which takes into account timing of dosage intakes using timestamped data from the devices.
Outcome measures
| Measure |
SMASH
n=40 Participants
Automated reminder functions activated on pill monitoring device, motivational text messages, at home BP monitoring
SMASH: Auditory and visual reminders are active on Pill device will alert subject each time their medication dose is due. Pill device will transmit dose taken time stamps to researchers. Text message the following morning with tailored motivational messages that reflect the medication dose adherence from the preceding day. Subjects will monitor their BP at home at least every third day using Bluetooth monitor linked to smartphone to transmit encrypted readings to researchers.
|
Enhanced SC
n=40 Participants
No reminder functions on the pill monitoring device, attention control text messages
Enhanced SC: Auditory and visual reminders are inactive on Pill device. Pill device will transmit dose taken times to researchers. Healthy lifestyle test messages as attention control.
|
|---|---|---|
|
Percent of Participants* With Medication Adherence to >.90" as Accurate and Appropriate
|
27.5 percentage of participants
Standard Deviation 29.4
|
80.3 percentage of participants
Standard Deviation 9.5
|
SECONDARY outcome
Timeframe: Months 1 and 6Changes in Medication Adherence Self-Efficacy (MASES-R) with increased self-efficacy (higher scores) desired. (attached) (Range: 1-4)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Month 6 of intervention period and at month 6 and 12 of follow-up period.24-hr ABP BP average SBP to (\< 130/80 mmHg) - 0 participants with this data reported. Our technology team changed half way through the trial and our ability to use the 24 hour ambulatory monitors code that was built within our institution and transfer it to use with the external data team was unsuccessful.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Months 3,6 of intervention period and at months 6 and 12 of follow-up period.Changes in Autonomous Motivation Questionnaire with increase in Relative Autonomy Index desired. (Attached)(Range -36 to 36)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Month 6 of intervention and months 6 and 12 of follow-up periodPercent of subject achieving and maintaining JNC8 Guidelines for BP control (\<140/90)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Months 3,6 of intervention period and at months 6 and 12 of follow-up period.Percent of subjects achieving and maintaining Medication Adherence \>.90.
Outcome measures
Outcome data not reported
Adverse Events
SMASH
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Enhanced SC
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
Dr. Jessica Chandler
Medical University of South Carolina
Phone: 843-792-1928
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place