Patient Centered Health Technology Medication Adherence Program for African American Hypertensives (NCT03454308) | Clinical Trial Compass
CompletedNot Applicable
Patient Centered Health Technology Medication Adherence Program for African American Hypertensives
United States204 participantsStarted 2017-04-28
Plain-language 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.
Who can participate
Age range21 Years – 59 Years
SexALL
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Inclusion criteria
✓. 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
✓. 24--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
Exclusion criteria
✕. 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
What they're measuring
1
Percent of Subjects Meeting JNC8 Guidelines for BP Control
Timeframe: at 6 months at the end of intervention
2
Percent of Participants* With Medication Adherence to >.90" as Accurate and Appropriate