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BACKGROUND The purpose of this article is to describe the research protocol for a randomized controlled trial of a self-management intervention for adults diagnosed with sickle cell disease (SCD). People living with SCD suffer with lifelong recurrent episodes of acute and chronic pain, both of which are exacerbated by stress. OBJECTIVE The aims of this study are to decrease stress and improve SCD pain control with reduced opioid use through an intervention with self-management relaxation/distraction exercises (RDE), named You Cope, We Support (YCWS). Building on our prior findings of formative studies, this study is designed to test the efficacy of YCWS on stress intensity, pain intensity, and opioid use in adults with SCD. METHODS A randomized controlled trial of the short-term (8 weeks) and long-term (6 months) effects of YCWS on stress, pain, and opioid use will be conducted with 170 adults with SCD. Patients will be randomized based on a 1:1 ratio (stratified on pain intensity [5]) to be either in the experimental (Self-monitoring of outcomes + alerts/reminders + use of YCWS [RDE + Support]) or control (Self-monitoring of outcomes + alerts/reminders) group. Patients will be asked to report outcomes daily. During weeks 1-8, patients in both groups will receive system-generated alerts/reminders via phone call, text, or email to facilitate data entry (both groups) and intervention use support (experimental). If the participant does not enter data after 24 hours, the study support staff will contact him/her for data entry troubleshooting (both groups) and YCWS use (experimental). We will time stamp and track patients' online activities to understand the study context and conduct exit interviews on the acceptability of system-generated and staff support. RESULTS The study was funded by the National Institute of Nursing Research of the National Institutes of Health in 2020. Our Institutional Review Board approved this study. Currently in the recruitment phase, the study began in March 2021 and will be concluded in June 2025. As of September 2021, we have enrolled 40 patients. We will analyze the data using the mixed-effects regression models (short-term, long-term) to account for the repeated measurements over time and utilize machine-learning to construct and evaluate prediction models. Due to the COVID-19 pandemic, the study was modified to allow for a mail-in consent process and a virtual consent process via email or Zoom video conference. CONCLUSIONS We expect that the intervention group will report reductions in pain intensity (primary outcome, 0-10 scale) and in stress intensity (0-10 scale) and opioid use, which are secondary outcomes. Our study will contribute to advancing the use of non-opioid therapy such as guided relaxation/distraction techniques for managing sickle cell pain. CLINICALTRIAL ClinicalTrials.gov NCT04484272 |
