This randomized clinical trial studies how well mobile technology works in monitoring pain and mobility in hospitalized patients with sickle cell disease, cancer, or undergoing bone marrow transplant. Giving patients mobile electronic devices with application to track their pain and wearable devices to automatically record their movements, heart rate, and sleep quantity may help to better manage their pain during hospitalization.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02895841.
PRIMARY OBJECTIVES:
I. To determine if wireless reporting of subjective pain scores coupled with objective movement data (activity, sleep, heart rate) by patients can reduce the magnitude of pain scores, decrease length of intravenous (IV) narcotics, increase mobility, and improve patient/family satisfaction. (Phase II)
II. To determine if wireless tracking of subjective symptoms (including pain scores) coupled with objective movement data (activity, sleep, heart rate) and direct patient feedback about data from the device to encourage ambulation can improve outcomes. (Phase III)
OUTLINE:
PHASE I: Patients look at the interface between pain reporting and logistics with tracking accelerometer data to identify key areas for improvements in the mobile application (app) and logistics. Patients enrolled in the bone marrow transplant arm undergo interview at 30, 60, 90 days, at the completion of the study. Hospitalized patients may optionally record a video 'selfie' up to 1 minute in length to answer the question 'How is your pain today?'.
PHASE II: Patients continue to collect core baseline data using the device and accelerometers.
PHASE III: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive an iPad mini to report pain scores via the Sickle cell Mobile Application to Record symptoms via Technology (SMART) mobile app 3 times per day, wear Microsoft Band 2 accelerometer to automatically track movement, heart rate, galvanic skin response, and sleep, and receive the education intervention (such as haptic prompted texts that state ‘try and walk today’, ‘have you had enough water today’, ‘make sure to take deep breaths’) for up to 7 days. Bone marrow transplant patients receive the mobile health technology up to 120 days whether inpatient or outpatient (or duration of post-transplant), whichever occurs first.
ARM II: Patients receive standard of care during hospitalization.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationDuke University Medical Center
Principal InvestigatorNirmish R. Shah
