Patient Centered Health Technology Medication Adherence Program for African American Hypertensives (SMASH)

• ClinicalTrials.gov Identifier: NCT03454308
• Recruitment Status: Active, not recruiting
• First Posted: March 5, 2018
• Last Update Posted: October 15, 2021
• Sponsor: Medical University of South Carolina
• Information provided by (Responsible Party): Jessica Chandler, Medical University of South Carolina

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Hypertension; Medication Non-Adherence	Behavioral: SMASH; Behavioral: Enhanced SC	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 204 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Other
• Official Title: Patient Centered Health Technology Medication Adherence Program for African American Hypertensives
• Actual Study Start Date: April 28, 2017
• Actual Primary Completion Date: June 30, 2021
• Estimated Study Completion Date: December 30, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: SMASH; Automated reminder functions activated on pill monitoring device, motivational text messages, at home BP monitoring	Behavioral: SMASH; 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; No reminder functions on the pill monitoring device, attention control text messages	Behavioral: Enhanced SC; 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.

Outcome Measures

Primary Outcome Measures :

1. Percent of subjects meeting JNC8 Guidelines for BP control (<140/90) [ Time Frame: at 6 months at the end of intervention ]
   Percent of subjects meeting JNC8 Guidelines for BP control (<140/90)
2. Percent of subjects with Medication Adherence to >.90. [ Time Frame: 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 :

1. Changes in Medication Adherence Self-Efficacy [ Time Frame: 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)
2. Percent Achieving and sustaining 24-hr BP control (< 130/80 mmHg) [ Time Frame: 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)
3. Changes in Autonomous Motivation [ Time Frame: 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)
4. Percent of subject achieving and maintaining JNC8 Guidelines for BP control (<140/90) [ Time Frame: 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)
5. Percent of subjects achieving and maintaining Medication Adherence >.90. [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 21 Years to 59 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, South Carolina

Medical University of South Carolina

Charleston, South Carolina, United States, 29425

Sponsors and Collaborators

Medical University of South Carolina

Investigators

• Principal Investigator: Jessica L Chandler, PhD; MUSC College of Nursing

  Study Documents (Full-Text)

Documents provided by Jessica Chandler, Medical University of South Carolina:

Study Protocol and Statistical Analysis Plan  [PDF] September 6, 2017

Informed Consent Form  [PDF] June 13, 2017

More Information

• Responsible Party: Jessica Chandler, Assistant Professor, Medical University of South Carolina
• ClinicalTrials.gov Identifier: NCT03454308
• Other Study ID Numbers: 452; HL130917 ( Other Identifier: NIH )
• First Posted: March 5, 2018
• Last Update Posted: October 15, 2021
• Last Verified: October 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Hypertension; Vascular Diseases; Cardiovascular Diseases