- The Lupus Research Alliance has partnered with Pfizer to launch an mHealth study on Apple’s ResearchKit platform.
The partnership launched an app this past June on Apple’s mHealth-based clinical trial platform as part of its VALUE (VAlidation in LUpus of an Electronic Patient Reported Outcomes Tool) study, which looks to allow patients of the debilitating chronic disease to report this conditions through an iPhone.
“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, the alliance’s co-CEO and co-president, 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.”
A chronic, complex autoimmune disease that affects millions of people worldwide, Lupus develops when the immune system, which enables protection against infection, creates antibodies that attack the body’s own tissues and organs. It’s characterized by unpredictable periods of illness, called flares, and can damage internal organs, degrade quality of life and lead to premature death.
It’s also an example of the partnerships being formed by pharma and healthcare providers to use mHealth to study populations and refine clinical treatments.
In an interview with Applied Clinical Trials, Albert Roy, executive director of the Lupus Clinical Investigators Network (LuCIN) – a network of academic research centers in the U.S. and Canada who are conducting the study - said the mHealth platform could help healthcare providers do away with a paper-based and in-person treatment process that strains providers and patients alike.
Roy said providers can use the HealthKit platform to coordinate three key tests with Lupus patients in their homes: an assessment of how the patient feels on any given day, a 36-questions survey measuring the patient’s functional health and well-being, and a visual analog scale that measures the patient’s pain assessment on a scale of 1 to 10.
“Traditional patient assessments in Lupus are unfortunately done in a very arcane way; it requires the patient to come to the clinic and complete a paper form,” he said. “Lupus patients don't come to the clinic every week unless they are very sick, so they have to recall weeks and weeks of how they felt and address the question in the most accurate way. We wanted to reduce this burden on the patients and see if we could translate all these instruments from paper into an electronic format.”
“Running the mobile app is an opportunity for patients to do the assessment on their own, in the comfort of their homes and on a smartphone,” Roy added. “We could get more accurate data since they would be able to answer these questions once or twice a week versus once a month. We could measure that against paper form submissions to see what would be more effective - Is the paper form just as good/worse/better than the electronic version?”
Roy said the study’s organizers considered adding the Apple Watch to the process to collect biometric data, but decided it would be too complex. He also noted study participants are being given special iPhone with only the app downloaded, instead of using their own smartphones.
“The current paper methods of collecting patient-reported data can be cumbersome and inconvenient, and often depend on memory,” Freda Lewis-Hall, MD, Pfizer’s executive vice president and chief medical dfficer, said in the press release. “VALUE holds promise for ‘in the moment’ reporting of symptoms and may open the door to similar tools being used in Pfizer-sponsored clinical studies for lupus and other diseases.”