UNITED KINGDOM / March 29, 2022 / eClinicalHealth, in collaboration with the Department of Dermatology at Wake Forest University School of Medicine, has created a digitized version of the SAPASI instrument, allowing researchers to monitor and record moderate-to-severe plaque psoriasis in clinical trial patients.
A part of eClinicalHealth’s growing decentralized clinical trial (DCT) research platform known as Clinpal, this new SAPASI ePRO tool prompts patients on any device including their bring-your-own devices, at protocol-specified time intervals, to manually mark where their psoriasis is on a digital body map and answer several prompts pertaining to the severity of the psoriasis lesions. This data is then immediately compiled into a data model for researchers to use and monitor the effectiveness of the treatment.
The digital map leverages Wake Forest’s validated diagnostic tool, the Self-administered Psoriasis Area Severity Index (SAPASI). Developed in 1995, the SAPASI was an upgrade from the Psoriasis Area Severity Index (PASI), which could only be evaluated by trained professionals who would observe the psoriasis in person. The modification of a self-administered version of the PASI allowed clinical studies to expand to more large-scale research of severe psoriasis.
Implementing SAPASI on the Clinpal platform was a logical extension of the library of ePRO tools. The platform has a quick clinical-study set-up, a patient-friendly design, and automatically calculates the SAPSI score with a built-in compliance reminder feature to make sure the most accurate data was secured. It fits perfectly in the existing Clinpal app with no custom development required.
Karl Landert, Chairman of the Board and CEO at eClinicalHealth said: “We’re excited about this evolution of our ePRO tools and pushing the Clinpal platform into new areas. The new normal world has revealed the benefits of a telemedicine ecosystem for end-users. As DCTs gain traction, our aim is to further scale and simplify patient engagement.”
This digital map functionality, part of the Capture module of the Clinpal platform, is one of seven modules that make up the entire DCT platform. Each module focuses on an essential role in clinical trials, such as patient recruitment, successful self-registration and pre-screening abilities, intentional communication to eradicate patient noncompliance before it begins, and valuable ePRO tools, such as the new digital SAPASI instrument.
About eClinicalHealth Ltd:
Headquartered in Scotland, eClinicalHealth Limited, developers of the ClinpalTM remote research platform, was founded in 2012 to provide innovative clinical trial solutions. The company is committed to being a premier Decentralized Clinical Trial (DCT) provider, developing patient-centric innovation in clinical trial processes and technology with pharmaceutical companies, CROs and other service and technology organizations.
About the Department of Dermatology at Wake Forest University School of Medicine:
The Department of Dermatology at Wake Forest University School of Medicine strives to improve skin health in all patients; educate patients, students and residents about skin disease; and to improve skin health through research. Led by Amy McMichael, M.D., chair of the department since 2013, the region’s leading dermatology team provides world-class training for future practitioners of dermatology and a productive setting for basic and applied research on diseases of the skin.
Karl Landert, CEO eClincalHealth, Ltd
+44 333 012 4205