A Stress and Pain Self-management m-Health App for Adult Outpatients With Sickle Cell Disease

Design. The study is a RCT of the short-term (8 weeks) and long-term (6 months) effects of YCWS on efficacy outcomes (pain, stress, and opioid use). We will stratify patients on worst pain intensity (<=5, >5) and randomly assign 170 adult outpatients to Control or Experimental groups. The Aim 3 analysis is exploratory to understand predictors of intervention effects.

Setting and Sample. The University of Florida (UF) will be the site for data collection, intervention delivery, and data analysis. Together, the UF Health Shands Hospital Pediatric and Adult sickle cell programs have a clinic panel of 700 (400 pediatric and 300 adult) patients with SCD. The available panel for this study is 403 patients with SCD (300 from the adult program and from the pediatric program 47 who currently are 18 years old and have not yet transitioned to adult care, and 56 who will become adults during our study period). We will use Internet and remote technologies, which will allow subjects to complete the study in their setting of choice where Internet service is available. We will also load some of the video clips on patients' mobile devices for use when the internet is not available. For those who meet the eligibility criteria, we anticipate enrolling 195 subjects in order to retain 170 subjects with complete data at 8 weeks based on a 13% attrition rate and approximately the rate observed in our previous longitudinal studies in which follow-up was more than a year.15 Randomization: Using our group's randomization software, we will use permuted block randomization with stratification based on worst pain intensity (<=5, > 5). We will randomly assign the 195 consecutively selected patients to the two study groups. Assignment will be unknown until a sealed electronic envelope is opened after a patient completes pretest data collection procedures.

Procedures. After introduction by clinic staff, the research specialist (RS) will approach patients during their outpatient clinic visits, inpatient hospitalization, or by phone or e-mail for those registered in the UF SCD research registry. The RS will explain the study and ascertain their willingness to participate. The RS will inform patients that participation is voluntary and a decision to decline participation will not affect their care. For patients choosing to participate, the RS will ask them to sign a written consent at the time of recruitment or on the day of the first study visit. The RS will contact the patients the day before the study visit as a reminder for the upcoming visit. After informed consent, patients will complete baseline measures and be randomly assigned to Experimental or Control groups (Figure 3). The RS will provide standardized instruction on how to use the study Galaxy tablet or their personal mobile device for daily study procedures at home, focusing on alerts/reminders, daily data entry, and customization of YCWS app via settings panel (Tolerable and optimal pain goal, time of day to complete study activities, etc.). For the short-term trial (the first 8 weeks), all patients will monitor their stress, pain, and opioid use daily and get automated system-generated alerts/reminders) every 24 hours via phone call, text, or email to facilitate data entry. Patients in the experimental group also will receive intervention support (Goal-setting, action planning, decision-making, and problem solving related to YCWS intervention use). If the patient does not enter data after 24 hours, study support staff will contact him/her for data entry trouble-shooting (both groups) and YCWS use (experimental). We will conduct an audio-recorded exit interview to explore barriers patients encountered using mobile devices for the intervention and for data collection, and acceptability of system-generated support. We will ask patients if they used the acute care center, emergency department, or were admitted to the hospital during our study period (verified by electronic chart review). For the long-term trial (months 3-6), patients in the experimental group will continue to have access to the banks of video links and will continue monitoring stress, pain, and opioid use daily with only system-generated alerts/reminders every 24 hours, if patient did not enter data. Patients in the control group also will continue monitoring stress, pain, and opioid use daily with system-generated alerts/reminders every 24 hours. We will also collect system-based daily activities during months 3-6.

Intervention. Experimental (Self-monitoring of pain, stress, and opioid use + alerts/reminders + use of YCWS [three video banks of RDE + Support]). Self-monitoring, using video banks, and getting support elements comprise the YCWS intervention. The YCWS App is comprised of three tabs displayed across the top of the screen, namely, self-monitoring, video banks, and support (Table 1). When patients click on "self-monitoring," stress intensity scale (0-10) and pain intensity scale (0-10) subtabs will display on the screen consecutively. Patients will touch the screen to record their stress and pain intensity. Once patients record their stress or pain intensity, they will receive instantaneous feedback via graphical readout showing their stress and pain during the past week (including the present day), their pain goals, and their daily YCWS use. An auxiliary icon under self-monitoring is "Goal Setting." Patient can use this auxiliary icon to revise optimal and tolerable pain goals, time of day to complete study activities including support, and setting alerts/reminders. When patients click "video banks," three sub-icons, basic, every-day, and favorite, will display. Patients can click any of the three banks to choose a specific video to watch. Patients can watch as many video clips as needed. Per patient preference, we will send system-generated alerts/reminders every 24 hours to patients via phone call, text, or email to facilitate data entry and intervention use. Patient clicking "getting support" tab also will open sub-tabs (report issue, chat, text, call [talk, FaceTime], email). Patient can connect with our support staff about issues related to YCWS intervention use (experimental group only), technical difficulty with study device or app for advice on what to do (both groups). Our support staff also will monitor our database daily. If the patient does not enter data after 24 hours after system-generated alerts/reminders, study support staff will contact him/her for data entry trouble-shooting and, for the experimental group, on YCWS use as they indicated in their goals.

During the short-term trial (Weeks 1-8), patients will monitor their stress and pain daily as described above. We will provide experimental group patients access to three video banks from which to choose their daily intervention. Patients will use only basic videos in Week 1 to get familiar with the intervention and learn deep breathing, relaxation exercise through instructions. During weeks 1-8, we will send automated system-generated alerts/reminders every 24 hours to experimental group patients via phone call, text, or email to facilitate intervention use. If the patient does not enter data after 24 hours, study support staff, who will be from the community, will contact him/her 2 hours prior to the next data collection time for trouble-shooting. This support staff will contact patients via chat, text, phone call, or FaceTime based on patients' preferences to facilitate participation and trouble-shoot.