A mobile app for managing stress and pain in adults with sickle cell disease
A Stress and Pain Self-management m-Health App for Adult Outpatients With Sickle Cell Disease
This study is testing a mobile app designed to help adults with sickle cell disease manage their stress and pain while trying to reduce their use of opioids.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 185 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | University of Florida Academic / other |
| Locations | 1 site (Gainesville, Florida) |
| Trial ID | NCT04484272 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a mobile health application called You Cope, We Support (YCWS) designed to help adults with sickle cell disease manage stress and pain while reducing opioid use. The study will recruit 170 participants who will be randomly assigned to either a control group or an experimental group that uses the YCWS app alongside self-monitoring tools. The trial will assess outcomes related to pain intensity, stress levels, and opioid consumption over an 8-week and 6-month period. Data collection will take place at the University of Florida, utilizing internet and remote technologies for participant convenience.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a diagnosis of sickle cell disease who experience moderate to severe pain and use opioids.
Not a fit: Patients who are legally blind, physically unable to complete the study procedures, or have previously participated in a related intervention may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could lead to improved pain management and reduced reliance on opioids for patients with sickle cell disease.
How similar studies have performed: Previous studies have shown promise in using mobile health interventions for pain management, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * with diagnosis of SCD (e.g., HbSS, HbSC, HbS-beta-0 thalassemia, and HbS-beta+ thalassemia); (b) reports moderate to severe level of pain (\>3 on 0-10 scale) related to SCD within previous 24 hours; (c) uses opioid analgesics on "as needed" or "continuous" basis (d) who speaks and reads English; and (e) is 18 years of age or older Exclusion Criteria: * are legally blind; (b) physically unable to complete procedures; (c) previously participated in our relaxation/distraction intervention feasibility study
Where this trial is running
Gainesville, Florida
- University of Florida — Gainesville, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Miriam O. Ezenwa — University of Florida
- Study coordinator: Muntaha Ali, MS
- Email: muntahaali@ufl.edu
- Phone: 352-273-6520
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.