An interventional study of SMASH and Enhanced SC in Hypertension and Medication Non-Adherence, sponsored by Medical University of South Carolina. Completed at 1 site in United States. Open to participants aged 21 Years to 59 Years. Per ClinicalTrials.gov, last updated 2025-06-13.
Sponsored by Medical University of South Carolina · Not applicable, Interventional, and Other
This will be a two--arm Randomized controlled trial (RCT) design that will assess efficacy of the Smartphone Medication Adherence Stops Hypertension (SMASH) mobile health ( mHealth) program compared to an enhanced standard care (SC) program. Participants will be African-American (AA) hypertension patients with no other known chronic diseases.
Participants found to have uncontrolled hypertension (HTN) and medication non-adherence via electronic device monitoring will be randomized to SMASH or enhanced Standard Care (SC). The SMASH group will receive reminders in the form of auditory and visual reminders from a pill monitoring device when their medication dose is due, they will monitor their blood pressure at home and will receive tailored motivational text messages based upon levels of adherence . Enhanced SC group will use the pill monitoring device without reminder functions enabled and will receive text messages on topics of healthy lifestyles not related to medication adherence and hypertension.
The active intervention will continue for 6 months and follow-up will continue for 1 year.
192 AAs (21-59 yrs ) with uncontrolled HTN (no other comorbidities) and Medication Non-Adherence (MNA) will be recruited according to the inclusion and exclusion criteria found elsewhere. In the first phase of screening,resting BP protocols will be performed to determine hypertension is uncontrolled. Only subjects with verified uncontrolled HTN will proceed to the second screening phase .This is a 4 week medication monitoring phase using an electronic medication device with reminder alerts deactivated.Medication non-adherence (MNA) will be determined through medication possession ratio and by the timestamped intake adherence to their predesignated intake schedule across the 4 week period. MA score \<0.85 over the 4-week screening and whose subsequent resting BP evaluations reconfirm uncontrolled HTN will be eligible for enrollment into the RCT.
SMASH subjects will have their pill monitor reminder functions activated, start receiving personalized motivational text messages and provided and instructed on use of a validated Bluetooth--enabled BP monitor used at home during the intervention period.
Enhanced SC subjects will continue to use the pill device with reminder functions disabled for another 6 months. In order to control for attention exposure SC subjects will be sent text messages on topics related to healthy lifestyle behaviors (diet, physical activity,no smoke exposure) but not related to Medication Adherence (MA) or HTN.
All subjects will complete 5 study visits where BP,medication possession ratios, and surveys will be completed. 24-hour Ambulatory Blood Pressure (ABP) monitoring will be performed every 6-months (4 times) during the study.
6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.
This study's enrollment of 204 is above the median of 100 across 4,575 interventional studies indexed under Hypertension.
Browse Hypertension studies →Medical University of South Carolina is the lead sponsor of 874 studies on the registry; 166 are open to participants now.
Of its 131 completed or terminated interventional studies of FDA-regulated products, 104 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Automated reminder functions activated on pill monitoring device, motivational text messages, at home BP monitoring
Behavioral: SMASH
No reminder functions on the pill monitoring device, attention control text messages
Behavioral: Enhanced SC
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.
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
Percent of subjects meeting JNC8 Guidelines for BP control (\<140/90)
Time frame: at 6 months at the end of intervention
Percent of Participants* With Medication Adherence to >.90" as Accurate and Appropriate
Medication 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.
Time frame: Average across 6 mos.of intervention
Changes in Medication Adherence Self-Efficacy
Changes in Medication Adherence Self-Efficacy (MASES-R) with increased self-efficacy (higher scores) desired. (attached) (Range: 1-4)
Time frame: Months 1 and 6
Percent Achieving and Sustaining 24-hr BP Control (< 130/80 mmHg)
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.
Time frame: Month 6 of intervention period and at month 6 and 12 of follow-up period.
Changes in Autonomous Motivation
Changes in Autonomous Motivation Questionnaire with increase in Relative Autonomy Index desired. (Attached)(Range -36 to 36)
Time frame: Months 3,6 of intervention period and at months 6 and 12 of follow-up period.
Percent of Subject Achieving and Maintaining JNC8 Guidelines for BP Control (<140/90)
Percent of subject achieving and maintaining JNC8 Guidelines for BP control (\<140/90)
Time frame: Month 6 of intervention and months 6 and 12 of follow-up period
Percent of Subjects Achieving and Maintaining Medication Adherence >.90.
Percent of subjects achieving and maintaining Medication Adherence \>.90.
Time frame: Months 3,6 of intervention period and at months 6 and 12 of follow-up period.
| Milestone | SMASH | Enhanced SC |
|---|---|---|
| Started | 97 | 107 |
| Completed | 97 | 107 |
| Not completed | 0 | 0 |
Percent of subjects meeting JNC8 Guidelines for BP control (\<140/90)
| Participants | SMASH | Enhanced SC |
|---|---|---|
| Percent of Subjects Meeting JNC8 Guidelines for BP Control | 97 | 106 |
Medication 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.
| percentage of participants | Enhanced SC | SMASH |
|---|---|---|
| Percent of Participants* With Medication Adherence to >.90" as Accurate and Appropriate | 27.5 ± 29.4 | 80.3 ± 9.5 |
Changes in Medication Adherence Self-Efficacy (MASES-R) with increased self-efficacy (higher scores) desired. (attached) (Range: 1-4)
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
Changes in Autonomous Motivation Questionnaire with increase in Relative Autonomy Index desired. (Attached)(Range -36 to 36)
Results for this outcome have not been posted.
Percent of subject achieving and maintaining JNC8 Guidelines for BP control (\<140/90)
Results for this outcome have not been posted.
Percent of subjects achieving and maintaining Medication Adherence \>.90.
Results for this outcome have not been posted.
Collected over up to 18 months. Non-serious events are listed at a 4% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| SMASH | 0/97 (0%) | 0/97 (0%) | 0/97 (0%) |
| Enhanced SC | 0/107 (0%) | 0/107 (0%) | 0/107 (0%) |
Participants were African American Adults with a sole diagnosis of uncontrolled hypertension
| Age, Categorical(Participants) | SMASH | Enhanced SC | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 97 | 107 | 204 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | SMASH | Enhanced SC | Total |
|---|---|---|---|
| Mean | 50.0 ± 9.3 | 47.0 ± 9.7 | 48.4 ± 9.6 |
| Sex: Female, Male(Participants) | SMASH | Enhanced SC | Total |
|---|---|---|---|
| Female | 65 | 74 | 139 |
| Male | 32 | 33 | 65 |
| Ethnicity (NIH/OMB)(Participants) | SMASH | Enhanced SC | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 97 | 107 | 204 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | SMASH | Enhanced SC | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 97 | 107 | 204 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | SMASH | Enhanced SC | Total |
|---|---|---|---|
| United States | 97 | 107 | 204 |
PDFs hosted by the registry, ClinicalTrials.gov.
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