Mobile Health (mHealth) technology can help individuals adopt healthy lifestyle behaviors, particularly in physical activity (PA) for the treatment and self-management of chronic diseases. As patient centered care melds with emerging patient centered technology, a need exists to promote effective patient-provider communication. This is especially important for minimally ambulatory, chronically ill populations. We propose FOOTFIT, a novel lower leg conditioning mHealth intervention for patients with venous leg ulcers.
We aim to compare two versions, one of which is enhanced (FOOTFIT+), to determine which has the greatest impact on PA adherence, patient-provider communication, and leg function. FOOTFIT and FOOTFIT+ share three components: 1) a low-cost, tri-axial Bluetooth(r) enabled highly sensitive accelerometer and tracking device (BEAT) worn on the foot during, 2) phased conditioning activities for lower leg function (CALF) tracked by a, 3) Smartphone that captures signals from BEAT, provides motivational messages, CALF instruction, and automated feedback on progress. FOOTFIT+ has the added component that promotes patient-provider communication through Internet connectivity via the Smartphone. We designed this PA intervention as an initial step in conditioning severely deconditioned lower legs of minimally ambulatory patients who have limited access to PA programs. To our knowledge, a system that connects accelerometers and patient-provider communication to examine adherence to PA in leg ulcer populations has not been tested. Two important features of this intervention are worth noting. First, foot-based accelerometry (e.g. Fitbit(r)) is well documented for the capture of activity and energy expenditure in mobile, healthier populations. Developed and tested by our study team, our valid and reliable foot-based BEAT emphasizes the capture of less intense activity (e.g. toe and foot movements) that is often the maximum intensities displayed by these deconditioned patients who can at best only take a few steps at a time. Secondly, the study will test the feasibility and acceptability of having a patient-provider communication link as part of FOOTFIT+. These patients will have access to the provider via the Smartphone (email, text, direct calling), and will receive automated and personalized, motivational messages and theory-based verbal exchanges from the provider. We seek to discover whether patients with leg ulcers use the FOOTFIT system as recommended and if it increases adherence to PA, promotes communication between patients and providers, reduces physically distressing symptoms, and enhances lower extremity functional abilities. We believe FOOTFIT+ will facilitate more timely and effective patient-provider communication around feedback on patient progress. We will evaluate how this will work in the real world with the strain that it might place on busy providers. Forty patients will be targeted in this six-week study, 20 o which will receive FOOTFIT and 20 FOOTFIT+.
The goal of this study is to test FOOTFIT and enhanced FOOTFIT+, home-based mHealth PA interventions for a minimally ambulatory, chronically-ill, population with leg ulcers. A highly sensitive clinically designed Bluetooth(r) enabled accelerometer and tracking device (BEAT) worn on the foot during a progressive and evidence-based non-exertive leg conditioning activities for lower leg function (CALF) captures minute foot movements and sends the data to a Smartphone. This six-week feasibility study will compare FOOTFIT to FOOTFIT+, with the added connectivity feature, to promote patient-provider communication, evaluate adherence to PA, and assess signals of efficacy on functional outcomes in a very low fitness population.
