June 26, 2017
By Adam DeVore, BioSpace.com Contributor
Heart failure remains a major public health issue, contributing to one in nine deaths, affecting 5.7 million adults in the United States, and generating costs of some $30.7 billion per year, taking into account health care services, medicines, and missed days of work , according to the Centers for Disease Control In heart failure clinical trials, several new therapies have been found to reduce mortality and hospitalizations, and increase quality of life. Yet, medication uptake has been poor, especially for newer therapies.
Management of heart failure can be overwhelming for patients and their caregivers. To help address this, a new study has been launched assessing patient-facing mobile health technologies to improve adherence to medication and to self-care routines such as physical activity and following fluid and sodium restrictions. Known as the Care Optimization through Patient and Hospital Engagement Clinical Trial for Heart Failure (CONNECT HF), this quality improvement study is enrolling high-risk, hospitalized patients with acute heart failure and reduced ejection fraction.
The trial is evaluating two heart failure quality improvement initiatives, one that targets health systems and one that engages patients through mobile health applications. This large-scale, pragmatic trial – involving a total of 8,000 patients at 160 hospitals—is the largest heart failure quality improvement trial to date in terms of the number of hospitals involved. Participants will be part of the trial for one year, which will include four follow-up calls with the trial team.
CONNECT-HF is being run by Duke Clinical Research Institute (DCRI), a division of Duke University, with funding from an independent investigator grant to Duke from Novartis .
While designing the trial, the CONNECT HF team collaborated closely with a group of patient advisers, called the Cardi-Yacks. These are people living with heart failure, who offered their real-life experiences to help researchers design a trial that would be useful for patients and easy to participate in.
Two new apps are being used in CONNECT HF, HealthStar and Fabulous, both of which were previously available in other formats and have been tailored to the management of heart failure based on feedback from patients. Developed in collaboration with the Duke University Center for Advanced Hindsight, these incorporate behavioral economic techniques to reward healthy behaviors and disincentivize unhealthy ones. The apps interact with the patients’ healthcare teams.
HealthStar focuses on rewards and disincentives—involving access or lack of access to games or apps—as people try to make behavior changes appropriate for heart failure. Fabulous is based on the concept of forming habits and rituals to create a healthy journey, including adhering to medications and to dietary and activity recommendations for heart failure.
Implementation of CONNECT HF is on schedule, with the first clinical site starting enrollment in April, and more sites are expected to start up over the coming months. Levels of enthusiasm are high both among patients and investigators.
Adam DeVore, MD, MHS, is a heart failure cardiologist at Duke University Center for Advanced Hindsight with a research appointment at the Duke Clinical Research Institute. His research is focused around health care quality and improving the outcomes of patients with all stages of heart failure. He is interested in extending the use of registries into randomized trials and published the first trial conducted within the Get With The Guidelines-Heart Failure program, a registry-based cluster randomized trial of quality improvement interventions. He is also interested in implementation projects for new heart failure therapeutics, including using pragmatic study designs and registry-based randomized trials to improve the translation of evidence-based care into clinical practice.
