PPD ACT devices

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The national headlines flooded in last month after researchers at the UNC School of Medicine became the newest users of Apple’s ResearchKit and CareKit for their cutting edge research on postpartum depression. 
But what those outlets failed to mention was a small Durham development and strategy firm helping make that research happen for the first time via an app. Little Green Software, named after the inspirational little green aliens from "Close Encounters of the Third Kind", is becoming a go-to for researchers hoping to recruit for and conduct their studies via mobile devices. 
The team of 11, eight in a renovated downtown building and three in Brazil, has helped Duke University’s Center for Advanced Hindsight build its (Sample) Size Matters survey app and other researchers at Duke study adolescent cancer survivors using a mobile game. But the PPD study may be its highest profile work since starting in 2008, giving it the potential to expand its capabilities to research of all kinds worldwide. 
“Part of our culture is working with people that are doing things that have impact,” says principal Don Mullen. UNC’s study, called PPD ACT (Action toward Causes and Treatment), certainly counts as that. Research shows that one in seven women suffer from postpartum depression but many more aren’t being treated for it. UNC hopes to reach 100,000 women, a figure well above traditional research studies, and in just six months. 
The press will certainly help, but the use of ResearchKit as well as the design of the app is a critical way that figure may be achieved. Key is a “no friction” consent process that’s part of ResearchKit but designed by Little Green Software to be way simpler and easy to understand than the traditional multiple pages of fine print required for research. 

PPD ACT privacy and consent
The PPD ACT contains an easy to understand consent process. Credit: Little Green Software/UNC
“We went to great effort to translate that digitally and make it really easy,” says founder and president Ed Holzwarth. There’s a quiz as part of the consent to make sure those who sign up for the study know what they are agreeing to. And information is presented in both brief paragraphs to click through as well as a visual representation at the end. Those who prefer a full document can also read that. 

ResearchKit makes research apps possible, scalable

Apple launched ResearchKit a year ago as an open source framework that lets researchers develop their own apps and surveys and then contribute them back into the ResearchKit community. 
Some of the inaugural apps include Asthma Health, a project with the Icahn School of Medicine at Mount Sinai to understand the disease’s triggers and help sufferers stay away from areas where they most frequently experience symptoms; C Tracker, a study for people living with Hepatitis C; and Autism & Beyond, a Duke University-led Child Mental Health Initiative project to create more affordable and accessible tools to screen mental health disorders in kids. 
According to Holzwarth, the technology is likely to become a standard for conducting research. It revolutionizes a process that used to require flyers on community bulletin boards, radio advertisements and snail mail letters to tens of thousands of potential participants only to yield a few hundred responses. It also eliminates the need for participants to even leave their homes to provide feedback. 
The only challenge is that most researchers don’t have the technical skills to put ResearchKit into practice. They also lack experience in keeping data secure and meeting privacy policies required by institutional research boards. Holzwarth says that’s what Little Green Software has mastered through its work with many education, research and health institutions. Privacy and security of the PPD ACT data is as certain as with HIPAA compliance.

Future of PPD and other studies 

In December, Apple released design guidelines for research apps to ensure that participants stay engaged in the study. And then in March, Apple released updates to the platform, along with CareKit, an interface for helping users understand their own health through symptom and care plan tracking as well as a way to share the inputs with doctors and family members. It includes easy ways to order 23andMe genetic tests as well as “spit kits” that can be integrated into the research. 
UNC’s app takes participants through a survey of childbirth, mood, anxiety levels and other symptoms, and if women meet certain standards, they can also consent to participate in a genetic testing portion of the study—a spit kit, funded by the National Institute of Mental Health, is sent to their homes and the results shared with both the women and the research team. 

PPD ACT stress and mood questions
The PPD ACT app includes survey questions around mood and stress levels. Credit: Little Green Software/UNC
There’s also a small section with coping resources and tips, but one that could be expanded over time so that women come back to the app when they are having symptoms or if they want to see how the study is going. That ongoing engagement was typically lacking in traditional studies.
To make the app more accessible, the team at Little Green Software is also working to translate the app in a variety of languages so women can sign up around the world. Already, teams in the UK and Australia are using it to collect data. 
More broadly, the work could be expanded to all kinds of research studies, and it could include the many sensors and wearable devices people now use to monitor their health. Little Green Software has experience in this realm. It helped one Canadian client called Orpyx, create a shoe insole with a foot pressure sensor to let diabetes sufferers know if they are cutting off circulation to the foot. Mobile and watch apps tell the person to get up and move around or remove the shoe. 
Holzwarth expects more research studies will connect with wireless devices like Bluetooth scales, fitness trackers and blood pressure monitors to track mood or activity levels as part of the survey. 
A few key challenges still persist. There’s no similar kit and open source marketplace for Android devices, and there’s still no easy way of collecting, storing and making sense of all the data. Little Green Software built its own database and back end for the UNC study, but it’s in talks with IBM Watson Health, which offers back-end services free for ResearchKit-based apps, with the ability to up-sell on big data analytics. 
“The more that services like Watson and devices are used and we have specialties that we can do efficiently, it’s going to become easier for researchers to translate their ideas into apps,” Holzwarth says.

Little Green Software published a full case study of the UNC project on its blog here