R01HL155301

A Novel Behavioral Intervention to Promote Adherence in Heart Failure

Heart failure (HF) affects nearly 6 million Americans and leads to significant impairments in functioning, quality of life, and survival. Health behaviors such as physical activity, low-sodium diet, and medications have been associated with improved health outcomes, including survival, in HF. However, most HF patients do not adhere adequately to these behaviors. Existing health behavior programs have had limited impact on adherence and cardiac outcomes, are inaccessible to many patients, and do not target psychological factors independently associated with heart health.

Motivational interviewing (MI)-based programs have been shown to increase engagement in HF self-care behaviors but may not be sufficient to improve downstream health outcomes in HF patients. Positive psychology (PP), which utilizes systematic activities such as using strengths and expressing gratitude to cultivate well-being, may be an important component of a health behavior program in HF. Positive psychological constructs are prospectively and independently associated with both health behavior adherence and improved cardiovascular health. PP interventions have been shown to improve these constructs and increase health behavior adherence in patients with or at risk for cardiovascular disease. Furthermore, PP could be combined with MI to promote self-efficacy, motivation, and intention to engage in health behaviors.

We recently completed a multi-stage project (REACH for Health) to develop a 12-week, telephone-delivered, combined positive psychology-motivational interviewing (PP-MI) intervention to promote physical activity, diet, and medication adherence in HF. We now aim to examine the efficacy of this program, with additional twice weekly PP and health behavior text messages for a total of 24 weeks, compared to an MI-based educational control condition, in an NIH Stage II, randomized clinical trial in 280 patients with New York Heart Association Class I-III HF and suboptimal adherence to physical activity, diet, or medications.

The primary study outcome will be change in objectively measured health behavior adherence, including moderate to vigorous physical activity (measured via accelerometer), sodium intake (24-hour urinary sodium), and medication adherence (medication event monitoring system electronic pill bottle). We hypothesize that PP-MI will lead to greater improvements in adherence compared to the MI-based educational condition. We will also measure the intervention's impact on psychological health, quality of life, functional outcomes, markers of cardiovascular health (e.g., body mass index, lipids, glucose), and major adverse cardiac events.

We will utilize our team's expertise in clinical trials, cardiology, and PP- and MI-based interventions to effectively and efficiently perform the proposed trial, which aims to "test [an] innovative approach...for maintaining individuals'...adherence to complex health care regimens," consistent with the goals of PA-18-722. If effective, we will examine the intervention's effects on cardiovascular health outcomes in a larger trial and will begin to explore ways to implement this potentially highly scalable intervention in clinical settings.

The General Hospital Corporation

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]

Boston, Massachusetts 021141100 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 378% from $800,890 to $3,825,196.