Previously submitted to: Journal of Medical Internet Research (no longer under consideration since Dec 24, 2021)
Date Submitted: Sep 17, 2020
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
SickleFit: Adherence, Feasibility and Validation of Fitbit Charge 3 Metrics in Steady-State Sickle Cell Patients
ABSTRACT
Background:
While the relationship of pain and sleep in sickle cell disease (SCD) has been described, the data are evolving around this complex relationship. In a prior study, using actigraphy and patient reported outcomes, our group determined that sleep quality deteriorates leading up to and during pain, and can be measured using an actigraph. We found that sleep parameters, particularly sleep fragmentation, is affected during pain episodes. This study is the first to determine the feasibility of identifying these parameters in real time using a Fitbit® Charge 3.
Objective:
This was a fourteen-week pilot trial investigating the feasibility of following activity profiles and sleep fragmentation in real time by using the Fitbit® Charge 3 in ten patients with sickle cell disease. The primary endpoint of this study was the percent of days data was captured from the Fitbit (target 75%). The secondary endpoint was to determine the feasibility of real-time monitoring of actigraphy and sleep fragmentation in steady-state sickle cell disease patients and to establish baseline actigraphy and sleep fragmentation indices in patients with SCD.
Methods:
Eligible subjects included patients with a confirmed diagnosis sickle cell disease, ages > or equal to 12 years and who have experienced > or equal to 2 episodes of pain requiring documented unplanned medical intervention with opioid treatment in the prior 12 months. This was a fourteen-week pilot trial investigating the feasibility of monitoring activity profiles and sleep fragmentation in real time by using the Fitbit Charge 3 in patients with sickle cell disease.
Results:
A mean of 88.4% of possible days per patient were captured (maximum – 100% and minimum – 44%) in 10 patients, and the primary endpoint was met. Feasibility was demonstrated on a post-study survey where patients reported no problems with the device, excellent practicality, no pain, discomfort or frustration wearing the device and complete satisfaction.
Conclusions:
This is the first study showing the ability of the FitBit® Charge 3 to be used as an actigraph in sickle cell disease patients to monitor activity and sleep. This provides clinicians with a unique and tangible ability to track activity and sleep in the clinical and research setting. The FitBit® Charge 3 may be also be useful in prediction of sickle cell outcomes of interest, offer the ability to intervene, and follow how these metrics change with new therapies. Clinical Trial: N/A
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