Patient Centered Health Technology Medication Adherence Program for African American Hypertensives

Not Applicable

• Conditions: Medication Non-Adherence; Hypertension
• Interventions: Behavioral: Enhanced SC; Behavioral: SMASH

• Registration Number: NCT03454308
• Lead Sponsor: Medical University of South Carolina

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-04-28
• Study First Submitted: 2018-02-21
• Study First Submitted QC: 2018-03-02
• Study First Posted: 2018-03-05
• Primary Completion: 2021-06-30
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-04
• Last Update Posted: 2022-04-05
• Study Completion: 2022-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 204

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Enhanced SC	Enhanced SC	No reminder functions on the pill monitoring device, attention control text messages
SMASH	SMASH	Automated reminder functions activated on pill monitoring device, motivational text messages, at home BP monitoring

Primary Outcome Measures

Name	Time	Method
Percent of subjects meeting JNC8 Guidelines for BP control (<140/90)	at 6 months at the end of intervention	Percent of subjects meeting JNC8 Guidelines for BP control (\<140/90)
Percent of subjects with Medication Adherence to >.90.	Average across 6 mos.of intervention	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.

Secondary Outcome Measures

Name	Time	Method
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 subject achieving and maintaining JNC8 Guidelines for BP control (\<140/90)
Changes in Medication Adherence Self-Efficacy	Months 3,6, of intervention period and at months 12 and 18 during follow-up period.	Changes in Medication Adherence Self-Efficacy (MASES-R) with increased self-efficacy (higher scores) desired. (attached) (Range: 13-52)
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.	24-hr ABP BP average SBP to (\< 130/80 mmHg)
Changes in Autonomous Motivation	Months 3,6 of intervention period and at months 6 and 12 of follow-up period.	Changes in Autonomous Motivation Questionnaire with increase in Relative Autonomy Index desired. (Attached)(Range -36 to 36)
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.	Percent of subjects achieving and maintaining Medication Adherence \>.90.

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States