Exco InTouch, the leading provider of patient communication solutions for the pharmaceutical and healthcare sectors, announces the commencement of its full mobile phone electronic data capture (EDC) study using the Western Ontario and McMaster Osteoarthritis (WOMAC) NRS 3.1 index after the success of their pilot study. The initial study is highlighted in Exco InTouch's technical poster, ‘Electronic Data Capture Using WOMAC NRS 3.1 Index: a Pilot Study of Cellular Technology in OA' which is available free-of-charge to download at www.excointouch.com.The preliminary study involved 12 patients and verified the benefits of EDC by asking patients to complete questionnaires via their mobile telephone.
The full study is now live and currently enrolling patients, already enlisting 31 subjects. The aim of the study is to further compare the effectiveness of patient self-reported outcome questionnaires completed on paper with those completed via a mobile phone using m-WOMAC, Exco InTouch's electronic version of the WOMAC Index.
The WOMAC index is a validated instrument used for assessing hip and knee Osteoarthritis (OA) and has gone through several validation tests and has been found to be a reliable and responsive measure of outcome in a variety of clinical environments. The index consists of a self-assessment questionnaire and addresses three dimensions of pain, disability and joint stiffness in OA through 24 questions. The index was modified slightly by Exco InTouch for use as a questionnaire application on mobile phones in the pilot study to evaluate the use of cellular technology in capturing the WOMAC NRS 3.1 index. Each of the patients, ten of whom had concomitant hand OA, completed three EDC questionnaires with a mobile phone using m-WOMAC. The completion time was automatically recorded and this method was found to be both convenient and efficient. The initial data suggest that the m-WOMAC is comparable to the traditional paper-based version of the questionnaire.
Tim Davis, Co-Founder, Exco InTouch comments: "We were overwhelmed with the success of the preliminary study into EDC using m-WOMAC. With this full study we will examine this electronic method on a broader range of subjects. EDC using a mobile phone offers unique benefits to both the patient and the clinical trial organiser, including simplifying the collection of patient-reported data and improving product-to-market time"
Exco InTouch's m-WOMAC is a Java-based application which runs on a patient's mobile phone and facilitates the completion of EDC questionnaires. Using m-WOMAC, questions are sent directly to a patient's mobile phone via text message. Patients are prompted to respond by entering a unique PIN number which ensures that data integrity is preserved. m-WOMAC from Exco InTouch removes the need for paper-based questionnaires and clinic attendance, facilitating EDC for both patients and clinical trial organisers. The m-WOMAC has been approved by the originator of WOMAC Index, and patients have rated the m-WOMAC self-reporting process as 'easy' or 'moderately easy' including those with limited dexterity.
