Clinical trial NCT03454308: Patient Centered Health Technology Medication Adherence Program for African American Hypertensives
Official title: Patient Centered Health Technology Medication Adherence Program for African American Hypertensives
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Medication Non-Adherence
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2018-03-05
Enrollment: 204
Sex: ALL
Minimum age (years): 21
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. African American or Black, 21--59 years old
2. Prescribed medication(s) only for HTN
3. Medication possession ratio (MPR) \<.85 for last 3 months
4. 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
5. 24--hour SBP ≥ 130 mmHg on clinic screening and subsequent recruitment evaluation
6. Ability to speak, hear and understand English
7. Able to take their own BP and self--administer medications
8. Owns smart phone with data plan
9. Primary care provider's assent that patient is able to participate

Exclusion Criteria:

1. 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
2. Beck Depression Inventory score \>13
3. Ongoing substance abuse (e.g., \>21 drinks/week)
4. Planned pregnancy
5. Vulnerable populations such as pregnant or nursing women, prisoners, and institutionalized individuals.

Primary outcomes:
measure: Percent of Subjects Meeting JNC8 Guidelines for BP Control
timeFrame: at 6 months at the end of intervention
measure: Percent of Participants* With Medication Adherence to >.90" as Accurate and Appropriate
timeFrame: Average across 6 mos.of intervention
Secondary outcomes:
measure: Changes in Medication Adherence Self-Efficacy
timeFrame: Months 1 and 6
measure: Percent Achieving and Sustaining 24-hr BP Control (< 130/80 mmHg)
timeFrame: Month 6 of intervention period and at month 6 and 12 of follow-up period.
measure: Changes in Autonomous Motivation
timeFrame: Months 3,6 of intervention period and at months 6 and 12 of follow-up period.
measure: Percent of Subject Achieving and Maintaining JNC8 Guidelines for BP Control (<140/90)
timeFrame: Month 6 of intervention and months 6 and 12 of follow-up period
measure: Percent of Subjects Achieving and Maintaining Medication Adherence >.90.
timeFrame: Months 3,6 of intervention period and at months 6 and 12 of follow-up period.
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: MUSC College of Nursing
name: Jessica L Chandler, PhD
role: PRINCIPAL_INVESTIGATOR
References: