Accepted for/Published in: JMIR Research Protocols
Date Submitted: Feb 7, 2019
Open Peer Review Period: Feb 11, 2019 - Feb 25, 2019
Date Accepted: May 10, 2019
(closed for review but you can still tweet)
TrackPAD: Effects of smartphone-based self-Tracking on pain-free walking distance in patients with peripheral arterial disease – study protocol for a randomized controlled pilot study
ABSTRACT
Background Peripheral arterial disease (PAD) is a common and severe disease with a highly increased cardiovascular morbidity and mortality. Through the circulatory disorder and the linked undersupply of oxygen carriers in the lower limbs, intermittent claudication occurs with a progressive decrease in walking distance that significantly reduces patients’ quality of life. Studies including activity monitoring for patients with PAD are rare and digital support to increase activity via mobile health (mHealth) technologies is mainly targeted to patients with cardiovascular disease in general. The special feature of patients with PAD is the need to reach a certain pain level to promote collateralization of the lower limb arteries. Unfortunately, both, poor adherence and availability of institutional resources are imminent problems in patient-centered care. The trackPAD pilot study aims to evaluate the feasibility of a smartphone based self tracking app to promote physical activity and supervised exercise therapy (SET) in particular. Subsequently, based on the patients’ wishes, a patient centered further development of the app will follow. Methods and study design The randomized, controlled pilot study includes 47 symptomatic participants with PAD and symptomatic, intermittent claudicatio (Fontaine stage IIa/b). Each participant has access to a smartphone suitable for IOS ≥ 10.0 or Android ≥ 5.0. The participants were randomly assigned into study and control group stratified by their six-minutes walking distance using the software TenAlea. Besides the standard care, with a recommendation to perform SET for both groups, the study group received the trackPAD app for a three months period. The feasibility and efficiency of the trackPAD app will be determined by a structured patient feedback and the comparison of the change in the six minutes walking distance between both groups. Ethics and dissemination Ethical approval is obtained from the ethics committee of the University of Duisburg-Essen (Germany). Results will be disseminated at conferences and in peer reviewed journals. Information regarding SET in PAD patients and the trackPAD app was spread via print media, social media channels and on our websites.
Citation
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