Clinical trial NCT05183763: Medication Adherence Program
Official title: Supporting Tailored Adaptive Change and Reinforcement for Medication Adherence Program: Randomized Trial of a Novel Approach to Improve Adherence in Older Hypertensive Women and Men
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hypertension
Medication Adherence
Behavior and Behavior Mechanisms
Lead sponsor: Tulane University
Sponsor class: OTHER
Collaborators: name: Ohio State University
name: Minds at Work
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2022-01-11
Enrollment: 402
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Difference in proportion with PDC >=0.8 at 12 months
timeFrame: 12 months
Secondary outcomes:
measure: Difference in mean change in PDC, baseline to 12 months
timeFrame: Baseline to 12 months
measure: Difference in mean change in 4-item Krousel-Wood Medication Adherence Scale score, baseline to 12 months
timeFrame: Baseline to 12 months
measure: Difference in proportion with 4-item Krousel-Wood Medication Adherence Scale score <1 at 12 months
timeFrame: 12 months
measure: Difference in change in proportion with high adherence as measured by urine metabolite analysis, baseline to 12 months
timeFrame: Baseline to 12 months
measure: Difference in proportion with controlled BP at 12 months
timeFrame: 12 months
measure: Difference in mean change in SBP, baseline to 12 months
timeFrame: Baseline to 12 months
measure: Difference in mean change in DBP, baseline to 12 months
timeFrame: Baseline to 12 months
measure: Difference in mean change in health-related quality of life scores, baseline to 12 months
timeFrame: Baseline to 12 months
Other outcomes:
measure: Difference in mean change in 4-item Krousel-Wood Medication Adherence Scale score, baseline to 6 months
timeFrame: Baseline to 6 months
measure: Difference in proportion with 4-item Krousel-Wood Medication Adherence Scale score <1 at 6 months
timeFrame: 6 months
measure: Difference in change in proportion with high adherence as measured by urine metabolite analysis, baseline to 6 months
timeFrame: Baseline to 6 months
measure: Difference in proportion with controlled BP at 6 months
timeFrame: 6 months
measure: Difference in mean change in SBP, baseline to 6 months
timeFrame: Baseline to 6 months
measure: Difference in mean change in DBP, baseline to 6 months
timeFrame: Baseline to 6 months
measure: Difference in mean change in health-related quality of life scores, baseline to 6 months
timeFrame: Baseline to 6 months
measure: Difference in proportion with PDC >=0.8 at 24 months
timeFrame: 24 months
measure: Difference in mean change in PDC, baseline to 24 months
timeFrame: Baseline to 24 months
measure: Difference in mean change in 4-item Krousel-Wood Medication Adherence Scale score, baseline to 24 months
timeFrame: Baseline to 24 months
measure: Difference in proportion with 4-item Krousel-Wood Medication Adherence Scale score <1 at 24 months
timeFrame: 24 months
measure: Difference in change in proportion with high adherence as measured by urine metabolite analysis, baseline to 24 months
timeFrame: Baseline to 24 months
measure: Difference in proportion with controlled BP at 24 months
timeFrame: 24 months
measure: Difference in mean change in SBP, baseline to 24 months
timeFrame: Baseline to 24 months
measure: Difference in mean change in DBP, baseline to 24 months
timeFrame: Baseline to 24 months
measure: Difference in mean change in health-related quality of life scores, baseline to 24 months
timeFrame: Baseline to 24 months
Locations:
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research Center
state: Louisiana
city: Covington
country: United States
facility: Tulane Doctors Dermatology & Multispecialty Clinic
state: Louisiana
city: Metairie
country: United States
facility: Tulane Doctors Heart & Vascular and Primary Care Clinic
state: Louisiana
city: New Orleans
country: United States
facility: Tulane University Clinical and Translational Unit
state: Louisiana
city: Shreveport
country: United States
facility: LSU Health Sciences Shreveport Clinical Trials Office
state: Louisiana
Study officials:
affiliation: Tulane University
name: Marie A Krousel-Wood, MD, MSPH
role: PRINCIPAL_INVESTIGATOR
References: