N/A
Completed N=204
Patient Centered Health Technology Medication Adherence Program for African American Hypertensives
Hypertension · Medication Non-Adherence
Source: ClinicalTrials.gov NCT03454308 ↗
Enrolled (actual)
204
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcomePrimary: Percent of Subjects Meeting JNC8 Guidelines for BP Control — 97; 106 Participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Subjects Meeting JNC8 Guidelines for BP Control |
97; 106 | — |
| PRIMARY Percent of Participants* With Medication Adherence to >.90" as Accurate and Appropriate |
27.5; 80.3 | — |
| SECONDARY Changes in Medication Adherence Self-Efficacy |
— | — |
| SECONDARY Percent Achieving and Sustaining 24-hr BP Control (< 130/80 mmHg) |
— | — |
| SECONDARY Changes in Autonomous Motivation |
— | — |
| SECONDARY Percent of Subject Achieving and Maintaining JNC8 Guidelines for BP Control (<140/90) |
— | — |
| SECONDARY Percent of Subjects Achieving and Maintaining Medication Adherence >.90. |
— | — |
Eligibility Criteria
Inclusion Criteria
- African American or Black, 21--59 years old
- Prescribed medication(s) only for HTN
- Medication possession ratio (MPR) 13
- Ongoing substance abuse (e.g., >21 drinks/week)
- Planned pregnancy
- Vulnerable populations such as pregnant or nursing women, prisoners, and institutionalized individuals.
Data sourced from ClinicalTrials.gov (NCT03454308). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.