The app’s effectiveness will be evaluated in a clinical trial expected to start at the end of this month. The study (NCT03142711) will be called VALUE, for Validation in Lupus of an Electronic Patient Reported Outcomes Tool.
Doctors usually obtain lupus patients’ reports of fatigue and other symptoms with on-paper surveys in their offices. The surveys can be inconvenient for both doctor and patient. They also may not be entirely accurate. That’s because patients often forget symptoms, particularly when visits to their physicians are scheduled far apart.
Pfizer, the Lupus Research Alliance and Tata used the Apple ResearchKit platform to build the app. The platform has proven to be a valuable for creating apps to collect and record information on other diseases, including asthma.
Lupus patients participating in the clinical trial will install the app on their iPhones and submit their symptoms as they occur over two months. The information collected through the smartphone will be compared with information collected through the traditional on-paper surveys in doctors’ offices.
Researchers want to see if information coming from the app is sufficient and accurate enough for doctors to use, and whether its can help in the treatment of lupus.
Results of the VALUE clinical trial are expected to be released in December 2017.
“This is an important step in demonstrating that mobile technology can improve how and what patients report to their care teams about subjective but serious symptoms of lupus, such as debilitating fatigue,” Kenneth M. Farber, co-CEO of the Lupus Research Alliance, said in a press release. “This app may enable more frequent and consistent reporting from patients, thus providing better information for care teams and empowering patients to take a larger role in developing future therapies.”
The Lupus Clinical Investigators Network is conducting the study. The Lupus Research Alliance contracts with the group to conduct clinical trials that can advance lupus research.