Duke to study two mobile apps in 8,000-patient quality improvement trial

By Jonah Comstock

The Duke Clinical Research Institute, funded by a grant from Novartis, is launching a large-scale study to explore the effectiveness of mobile apps in the treatment of heart failure patients. The study, called Connect HF, is aiming to enroll 8,000 patients across 160 hospitals by the end of fall 2018, with results hoped for by the end of 2020.

"CONNECT HF is a clinical trial looking at different quality improvement initiatives in heart failure," Dr. Adam DeVore, Assistant Professor of Medicine, told MobiHealthNews. "And right now in heart failure there are a lot of different hospital-based programs that providers and hospital systems employ to try to improve patient outcomes, but we don’t have a big evidence base for a lot of the things that we do. So a number of us as investigators had the idea to try to test some of these things in the context of a clinical trial."

Two of the major initiatives being studied are a pair of mobile apps, one from Pattern Health called HealthStar and another called Fabulous. Different groups will be randomized to each app, and the control group will be given a third app that just has information about heart failure.

"Pattern Health is really designed around trying to manage living with heart failure. It has a lot of information and tips to help people manage their fluid intake, daily weight, and has some tools to help with medication adherence," DeVore said. "It includes rewards and punishments to try to help patients make behavior change to improve upon their performance on those things. For example, remembering to take your medications every day, patients are randomized to different kinds of rewards to help with that. Fabulous is very different, the idea behind it is it helps people trying to make change. The concept is a journey. It helps them set goals and create rituals around remembering to make small steps toward those goals. For instance, trying to create a ritual around taking your medication so it’s a pleasant experience and becomes a habit over the long run. They’re very different but both really interesting." 

DeVore says that the study is unique for a number of reasons. In addition to being the largest study to date of its kind (aimed at quality improvement measures in heart failure), it's also being developed with the help of a panel of patient advisors, called the Cardi-Yaks. 

"They really liked and embraced the idea of trying to use mobile apps to address heart failure," DeVore said. "We weren’t sure if it was something patients would want to do, coming out of the hospital with a lot of things on their mind just trying to get home. But our patient panel has a lot of experience both living with heart failure and having to be treated in hospitals around the country and they really liked the idea. They had some good ideas of how to use the apps, one being about medication adherence. That’s really one of the cornerstones of the apps –  trying to help people understand and take their medications."

The study also goes against the grain of a lot of other studies these days because it takes the emphasis off the 30-day readmission window, which many researchers are focusing on because of its implications for value-based care.

"Everybody cares about being in the hospital, so that’s one important aspect of it, but it really seems like one small sliver when you think about the whole heart failure journey for a patient," DeVore said. "So I think there’s been a little bit of an over-emphasis on that lately because of the financial penalties. Connect is not only focusing on 30-day hospitalizations, it’s thinking about the next year after the patient leaves the hospital."

If the study goes well, Duke may incorporate these apps into its workflow as a matter of course.

"We’ll learn about the idea of trying to incorporate apps for these patients to try to help change behavior – does that concept even work? And then we are testing two different apps so I hope we’ll learn what aspects are most effective and can be carried into routine clinical care," he said. "The nice thing about an app is it’s easily scalable, so if we can find things that work we can easily disseminate that."