Patient Centered Health Technology Medication Adherence Program for African American Hypertensives

Part of paid clinical trials in Charleston, South Carolina.

Sponsor
Medical University of South Carolina
Study ID
NCT03454308
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - 59 Years
Healthy Volunteers
Not accepted

Interventions

  • SMASH — BEHAVIORAL
    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 — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Apr 28, 2017
Status verified
Jun 2025
Primary completion
Aug 17, 2021
Completion
Aug 17, 2021

Study Design

Enrollment
204 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: SMASH
    Automated reminder functions activated on pill monitoring device, motivational text messages, at home BP monitoring
  • Other: Enhanced SC
    No reminder functions on the pill monitoring device, attention control text messages

Primary Outcome Measure

Percent of Subjects Meeting JNC8 Guidelines for BP Control [ Time Frame: at 6 months at the end of intervention ]

Locations (1)

FacilityCityStateZIPSite coordinators
Medical University of South CarolinaCharlestonSouth Carolina29425-

Find similar trials in Charleston, SC

By condition
Hypertension (high blood pressure)
By specialty
CardiologyHeart disease
By research site
Medical University of South Carolina· Charleston, SC

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