Behavior and Behavior Mechanisms, Hypertension, Medication Adherence
Conditions
Brief summary
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) \>=40 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.
Interventions
BEHAVIORALSTAR-MAP health coaching
Interactive health coaching delivered in 11 sessions over one year; focusing on using adaptive change tactics to improve medication-taking behavior
BEHAVIORALMedication reminder tools
Medication-taking reminder app and pillbox
Sponsors
Tulane University
Ohio State University
Minds at Work
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Caregiver, 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. 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.
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
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 ≥40 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in proportion with PDC >=0.8 at 12 months | 12 months | Proportion of days covered (PDC) calculated from pharmacy refill data |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in mean change in PDC, baseline to 12 months | Baseline to 12 months | Proportion of days covered (PDC) calculated from pharmacy refill data |
| Difference in mean change in 4-item Krousel-Wood Medication Adherence Scale score, baseline to 12 months | Baseline to 12 months | Self-reported adherence measured by 4-item Krousel-Wood Medication Adherence Scale (K-Wood-MAS-4; minimum value: 0 (better adherence); maximum value: 4 (worse adherence)) |
| Difference in proportion with 4-item Krousel-Wood Medication Adherence Scale score <1 at 12 months | 12 months | Self-reported adherence measured by 4-item Krousel-Wood Medication Adherence Scale (K-Wood-MAS-4; minimum value: 0 (better adherence); maximum value: 4 (worse adherence)) |
| Difference in change in proportion with high adherence as measured by urine metabolite analysis, baseline to 12 months | Baseline to 12 months | Adherence determined by liquid chromatography tandem mass spectrometry analysis of urinary metabolites of antihypertensive medications |
| Difference in proportion with controlled BP at 12 months | 12 months | Controlled blood pressure (BP) defined as systolic BP \<130 mm Hg and diastolic BP \<80 mm Hg; BP measured using standardized protocol |
| Difference in mean change in SBP, baseline to 12 months | Baseline to 12 months | Systolic blood pressure (SBP) measured using standardized protocol |
| Difference in mean change in DBP, baseline to 12 months | Baseline to 12 months | Diastolic blood pressure (DBP) measured using standardized protocol |
| Difference in mean change in health-related quality of life scores, baseline to 12 months | Baseline to 12 months | Quality of life measured using 12-item Short Form Survey (SF-12); scores for eight subscales, Mental Component Summary, and Physical Component Summary calculated and compared (minimum: 0 (worse quality of life); maximum: 100 (better quality of life)) |
Countries
United States
Contacts
CONTACTErin M Peacock, PhD, MPH
CONTACTMarie A Krousel-Wood, MD, MSPH
PRINCIPAL_INVESTIGATORMarie A Krousel-Wood, MD, MSPH
Tulane University
Outcome results
None listed