Purpose

Randomized controlled trial testing the efficacy of the Supporting Tailored Adaptive change and Reinforcement for Medication Adherence Program (STAR-MAP), a health coaching approach that aims to improve antihypertensive medication adherence, blood pressure control, and quality of life. Participants (n=402) >=55 years old with a diagnosis of hypertension, uncontrolled blood pressure, and low antihypertensive medication adherence will be recruited through a statewide health insurer, Blue Cross Blue Shield of Louisiana, and randomized to receive either interactive health coaching sessions with medication reminder tools (intervention) or medication reminder tools only (control) over one year. Data will be collected from participants at baseline, 6 months, 12 months, and 24 months using questionnaires, physical measurement (height, weight, blood pressure), a computer-based single-category implicit association test, and laboratory analysis of antihypertensive medication urinary metabolites.

Conditions

Eligibility

Eligible Ages
Over 55 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • fully insured by Blue Cross Blue Shield of Louisiana (BCBSLA) - continuously enrolled in BCBSLA for one year - planning to remain a member of BCBSLA for next year - English-speaking - telephone access - aged ≥55 years - diagnosis of essential hypertension (ICD-10-CM code I10) - currently filling antihypertensive medication - low antihypertensive medication refill (proportion of days covered (PDC) <0.8) - low self-report adherence (4-item Krousel-Wood Medication Adherence Scale (K-Wood-MAS-4) score ≥1) - uncontrolled blood pressure (BP) (systolic BP ≥130 mm Hg or diastolic BP ≥80 mm Hg) - desire to improve BP

Exclusion Criteria

  • living in a household with someone already enrolled in the study - enrollment in another clinical trial for drug adherence or BP control - moderate to severe cognitive impairment

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Double (Care Provider, Outcomes Assessor)
Masking Description
The Data Manager will calculate the primary outcome measure from pharmacy refill data prior to merging with any data file indicating group assignment. BP measurements will be collected by research clinic staff, who will be blinded to group assignment. Laboratory technicians who perform the liquid chromatography tandem mass spectrometry analysis of urine metabolites of antihypertensive medications will also be blinded to group assignment. Finally, participants' primary care providers will be notified of their patients' enrollment into the study but will not be given information about group assignment.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
STAR-MAP
Interactive health coaching sessions and medication reminder tools
  • Behavioral: STAR-MAP health coaching
    Interactive health coaching delivered in 11 sessions over one year; focusing on using adaptive change tactics to improve medication-taking behavior
  • Behavioral: Medication reminder tools
    Medication-taking reminder app and pillbox
Active Comparator
Medication App and Reminder System Medication Adherence Program (MARS-MAP)
Medication reminder tools only
  • Behavioral: Medication reminder tools
    Medication-taking reminder app and pillbox

Recruiting Locations

Tulane University Clinical and Translational Unit
New Orleans, Louisiana 70112
Contact:
Erin Peacock
504-988-1075
epeacoc@tulane.edu

More Details

Status
Recruiting
Sponsor
Tulane University

Study Contact

Erin M Peacock, PhD, MPH
504-988-1075
epeacoc@tulane.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.