Wellframe Validation Study
Research type
Research Study
Full title
Outcome Assessment and Validation in TKA patients using PROMIS CATs and the Oxford Knee Score
IRAS ID
251080
Contact name
Tim Waters
Contact email
Sponsor organisation
Smith & Nephew Orthopaedics AG
Duration of Study in the UK
1 years, 1 months, 0 days
Research summary
Wellframe Inc. has developed a platform for patient engagement and education, with the goal of improving quality of care. The Wellframe Platform consists of a mobile application (App) and a clinician dashboard. The App has several features including messaging between clinical staff/technical support staff and patients, reminders to patients to engage in health behaviors (e.g. take medication), interactive surveys, educational articles, and encouragement. The clinician dashboard allows for staff at the clinical site to remotely monitor the patient’s responses to the surveys presented in the App.
Smith & Nephew recently engaged Wellframe to adapt their platform for use as a potential research tool. As such, Wellframe has added patient reported outcomes (PROs) to their platform with the hope of reducing burden on research subjects and, in turn, increasing compliance and reducing loss to follow-up. Specifically, Wellframe has added the Patient Reported Outcome Measurement Information System (PROMIS) Computer Adaptive Tests (CATs), where the next question in the PRO is based on the response to the previous question, to reduce the question burden to as few as four questions. For example, if a patient says he/she struggles to get out of bed the app will not go on to ask whether he/she can easily walk 2 miles. Using these scores instead of traditional PROs should further help to increase compliance and loss to follow-up in research studies.
This validation study aims to assess the utility of using PROMIS CATs by assessing outcomes in subjects receiving TKA via PROMIS CAT Physical Function, Pain Interference, and Depression domains and by validating these against the gold standard of the Oxford Knee Score.
REC name
North West - Greater Manchester East Research Ethics Committee
REC reference
18/NW/0615
Date of REC Opinion
5 Oct 2018
REC opinion
Further Information Favourable Opinion