Thai Version of PainPREDICT: Translation, Validation, and Mobile App Development for Screening Painful Diabetic Neuropathy in Diabetes Patients

What this Trial Is About

Painful diabetic neuropathy (PDN) is a common and disabling complication of diabetes that greatly impacts quality of life and daily functioning. Early detection is important to enable timely treatment and prevent serious complications like foot ulcers and amputations. In Thailand, there are limited culturally adapted tools to screen for PDN. This research aims to translate, adapt, and validate the PainPREDICT questionnaire for Thai patients and integrate it into a mobile health application to improve screening accessibility, especially in resource-limited settings. The study is conducted in three phases. First, the PainPREDICT questionnaire will be translated into Thai, culturally adapted, and tested for reliability and validity using expert review, pilot testing, and comparison with existing neuropathic pain measures and neurophysiological tests. Next, a mobile application embedding the validated Thai questionnaire will be developed and tested for usability by patients and clinicians. Finally, the diagnostic accuracy and real-world use of the app will be evaluated in 200 to 300 adults with type 1 or type 2 diabetes, comparing results to clinical diagnosis and neurophysiological testing. Participants will be adults with diabetes who can communicate in Thai and provide consent. They will complete the Thai PainPREDICT questionnaire either via the mobile app or paper form. Researchers will collect data on reliability, validity, usability, and diagnostic accuracy through questionnaires, clinical assessments, nerve conduction studies, and sensory testing. Data security and privacy will be maintained according to Thai regulations. The study aims to develop a reliable, culturally appropriate tool to enhance early PDN detection and improve patient care across Thailand.

Thai PainPREDICT Validation Study