Patient Centered Health Technology Medication Adherence Program for African American Hypertensives

NCT03454308 | Completed Results

• 2 other identifiers: 452HL130917
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypertension; Medication Non-Adherence

Outcome Measures

Primary Outcomes (2)

• Percent of Subjects Meeting JNC8 Guidelines for BP Control

  Percent of subjects meeting JNC8 Guidelines for BP control (\<140/90)

  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.

  Average across 6 mos.of intervention

Secondary Outcomes (5)

• Changes in Medication Adherence Self-Efficacy

  Months 1 and 6

• Percent Achieving and Sustaining 24-hr BP Control (< 130/80 mmHg)

  Month 6 of intervention period and at month 6 and 12 of follow-up period.

• Changes in Autonomous Motivation

  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)

  Month 6 of intervention and months 6 and 12 of follow-up period

• Percent of Subjects Achieving and Maintaining Medication Adherence >.90.

  Months 3,6 of intervention period and at months 6 and 12 of follow-up period.

Study Arms (2)

SMASH

EXPERIMENTAL

Automated reminder functions activated on pill monitoring device, motivational text messages, at home BP monitoring

Behavioral: SMASH

Enhanced SC

OTHER

No reminder functions on the pill monitoring device, attention control text messages

Behavioral: Enhanced SC

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.

SMASH

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.

Enhanced SC

Eligibility Criteria

• Age: 21 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• African American or Black, 21--59 years old
• Prescribed medication(s) only for HTN
• Medication possession ratio (MPR) \<.85 for last 3 months
• uncontrolled HTN (SBP ≥130 mmHg) based upon last clinic visit within previous 12 months, initial clinic screening \& subsequent baseline recruitment evaluation following one month med intake screening with score of \<.85
• hour SBP ≥ 130 mmHg on clinic screening and subsequent recruitment evaluation
• Ability to speak, hear and understand English
• Able to take their own BP and self--administer medications
• Owns smart phone with data plan
• Primary care provider's assent that patient is able to participate

You may not qualify if:

• No other known chronic disease (e.g., chronic kidney disease (GFR\<50 mL/1.7 m2/min;; diabetes (type one or two) renal dialysis cancer diagnosis or treatment in past 2 years prior cv event such as heart attack, congestive heart failure, arterial stent, coronary artery bypass graft psychiatric illness
• Beck Depression Inventory score \>13
• Ongoing substance abuse (e.g., \>21 drinks/week)
• Planned pregnancy
• Vulnerable populations such as pregnant or nursing women, prisoners, and institutionalized individuals.

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Hypertension; Medication Adherence

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Results Point of Contact

• Title: Dr. Jessica Chandler
• Organization: Medical University of South Carolina

chandlje@musc.edu

843-792-1928

Study Officials

• Jessica L Chandler, PhD

  MUSC College of Nursing

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2018
• First Posted: March 5, 2018
• Study Start: April 28, 2017
• Primary Completion: August 17, 2021
• Study Completion: August 17, 2021
• Last Updated: June 13, 2025
• Results First Posted: June 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)