R01HL153750

Supporting Tailored Adaptive Change and Reinforcement for Medication Adherence Program (STAR-MAP): Randomized Trial of a Novel Approach to Improve Adherence in Older Hypertensive Women and Men - Project Summary

There is a fundamental gap in the availability of interventions that 1) sustainably improve adherence to prescribed blood pressure (BP) medications, 2) identify underlying behavior change mechanisms, and 3) demonstrate efficacy by sex and race in older adults. Accordingly, interventions to improve adherence and BP control remain minimally effective.

The long-term goal is to improve medication adherence, BP control, and healthy aging in older hypertensive adults. The overall objective for this R01 application is to determine the efficacy of the Supporting Tailored Adaptive Change and Reinforcement for Medication Adherence Program (STAR-MAP), which integrates the transformative Overcoming Immunity-to-Change (OITC) health coaching process, on improving adherence, BP control, and quality of life (QOL). The OITC approach that has proven useful in other arenas was successfully applied to BP management in the research team's recent pilot study.

Based on this prior work, the central hypothesis is that STAR-MAP, designed to help nonadherent older hypertensive adults to identify and alter implicit attitudes that hinder medication adherence, will change mindsets and improve daily taking of prescribed medications, leading to lowered BP and better QOL. The rationale for the proposed study is that demonstration of the efficacy of STAR-MAP would provide new opportunities to overturn nonadherent behavior and improve BP control and healthy aging for the growing population of older adults with hypertension, overall and in sex and race subgroups.

The central hypothesis will be tested by pursuing two specific aims: (1) determine the efficacy, underlying mechanism, and sustainability of the STAR-MAP intervention, aimed at improving medication-taking behavior, on medication adherence and clinical outcomes; and (2) explore the efficacy of STAR-MAP in sex and race subgroups.

Under the first aim, a randomized controlled trial will be conducted in 402 nonadherent (proportion of days covered (PDC) <0.8) adults ≥65 years with uncontrolled BP (201 per arm – intervention versus usual care; 50% women; 50% black) and fully insured by Blue Cross Blue Shield of Louisiana. The study will have 90% statistical power to detect a 15% difference at 12 months in the proportion of participants with PDC ≥0.8 between those randomized to intervention versus usual care with attention control.

Under the second aim, efficacy of STAR-MAP in sex and race subgroups will be explored. The approach is innovative because it will be the first large clinical trial to rigorously test a new intervention that targets negative implicit attitudes toward medications with a goal to improve adherence, BP control, and QOL.

The proposed research is significant because it will represent an important step in a continuum of research that is expected to lead to an efficacious, scalable intervention (with data on the underlying behavior change mechanism). Finally, the results are expected to provide new insights on an underappreciated psychological mechanism (i.e., implicit attitudes) of nonadherence that could be useful for improving the effectiveness of other medication adherence interventions.

The Administrators Of Tulane Educational Fund

TO FOSTER HEART AND VASCULAR RESEARCH IN THE BASIC, TRANSLATIONAL, CLINICAL AND POPULATION SCIENCES, AND TO FOSTER TRAINING TO BUILD TALENTED YOUNG INVESTIGATORS IN THESE AREAS, FUNDED THROUGH COMPETITIVE RESEARCH TRAINING GRANTS. SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM: TO STIMULATE TECHNOLOGICAL INNOVATION, USE SMALL BUSINESS TO MEET FEDERAL RESEARCH AND DEVELOPMENT NEEDS, FOSTER AND ENCOURAGE PARTICIPATION IN INNOVATION AND ENTREPRENEURSHIP BY SOCIALLY AND ECONOMICALLY DISADVANTAGED PERSONS, AND INCREASE PRIVATE-SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT FUNDING. SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM: TO STIMULATE TECHNOLOGICAL INNOVATION, FOSTER TECHNOLOGY TRANSFER THROUGH COOPERATIVE R&D BETWEEN SMALL BUSINESSES AND RESEARCH INSTITUTIONS, AND INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL R&D.

93.837 - Cardiovascular Diseases Research

National Heart Lung and Blood Institute (NHLBI) [HHS - NIH]

New Orleans, Louisiana 701185698 United States

Single Zip Code

Improving Patient Adherence to Treatment and Prevention Regimens to Promote Health (R01 Clinical Trial Optional) (PA-18-722)

Amendment Since initial award the total obligations have increased 422% from $642,426 to $3,351,354.