PROJECT SUMMARY
More than 5 million Americans live with heart failure (HF), a serious condition with 5-year mortality rates of
50% and medical care costs reaching almost $40 billions nationally. Although pharmacological treatment
reduces mortality and costs, over half of HF patients do not take their medications regularly. Poor medication
adherence results in worse clinical outcomes and additional costs. Studies designed to improve adherence
have had mixed results and have often employed complex interventions with low scalability and sustainability
in clinical settings. The American Heart Association and the American College of Cardiology have recently
highlighted the need to develop novel, highly scalable interventions to improve medication adherence and
clinical outcomes in this high-risk population. This application, designed in response to PA-14-335 “Advancing
Interventions to Improve Medication adherence”, seeks to study the possible role of mindfulness training, (MT),
a behavioral intervention aimed at developing increased attention and awareness of moment-to-moment
experiences, in the promotion of medication adherence among patients with HF. There is evidence supporting
the efficacy of MT in improving patient-level factors that are associated with poor medication adherence in this
population (i.e., memory and attention deficits; depression). Preliminary, observational findings generated by
our group and others show that higher mindfulness skills are associated with better medication adherence and
that self-reported medication adherence improved after class-based MT in a small group of patients (n=8) with
stable cardiovascular disease. Our preliminary work has also shown that MT (usually delivered in a class-
based format) can be successfully phone-delivered by trained instructors with great potential for scalability. No
study, however, has yet formally explored the role of MT in improving medication adherence. We propose to
use this exploratory funding mechanism to conduct a prospective, pre/post design study among 50 stable
outpatients with class I-III HF and suboptimal medication adherence (Morisky scores <6). MT sessions (one
individual 30-min session/week for 8 weeks) will be phone-delivered by qualified mindfulness instructors. Data
will be collected at baseline, 2- (intervention completion), and 6 months since baseline. The primary outcomes
will be feasibility and acceptability. Secondary outcomes will be changes in medication adherence (multi-modal
assessments including objective and self-reported measures of adherence and functional status, a clinical
marker of medication adherence). Exploratory outcomes will be changes in cognitive function, depressive
symptoms, and mindfulness skills. We hypothesize that phone-delivered MT will be feasible and acceptable to
patients with HF and will improve adherence to medications. In addition, we expect to observe improvements
in cognitive function (and, possibly, mindfulness and depressive symptoms), and that such changes will be
associated with improvements in medication adherence. If the efficacy of phone-delivered MT in improving
medication adherence is proven in a future large RCT, it will be easily disseminable to primary care settings.
