A Stress and Pain Self-management mHealth App for Adult Outpatients With Sickle Cell Disease: Protocol for a Randomized Controlled Study.
Miriam O Ezenwa, Yingwei Yao, Molly W Mandernach...
https://pubmed.ncbi.nlm.nih.gov/35904878Actively Recruiting
Phase Not Applicable
Age: 18Years - 99Years
All Genders
ID04484272
A Stress and Pain Self-management m-Health App for Adult Outpatients With Sickle Cell Disease
Led by University of Florida · Updated on 2025-08-01
185
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Florida
Lead Sponsor
N
National Institute of Nursing Research (NINR)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a mobile health app called You Cope, We Support (YCWS) designed to reduce stress and improve pain control while lowering opioid use in adults with sickle cell disease (SCD). SCD causes recurrent acute and chronic pain episodes worsened by stress. This randomized controlled trial aims to test the short-term (8 weeks) and long-term (6 months) effects of YCWS on pain, stress, and opioid use in 170 adults with SCD. The study also explores prediction models for patient outcomes using machine learning based on personal and environmental factors. Participants are randomly assigned to one of two groups: a control group that self-monitors pain, stress, and opioid use with alerts/reminders, and an experimental group that receives the same self-monitoring plus access to YCWS, which includes video banks of relaxation and distraction exercises and support features. During the first 8 weeks, both groups receive daily automated reminders to report outcomes, with additional intervention support and video use encouraged for the experimental group. For months 3 to 6, both groups continue daily monitoring with reminders, but only the experimental group retains access to YCWS video resources. Participants will report their stress and pain levels daily using 0-10 scales and track opioid use with special software and medication monitoring devices. The study team will monitor data entry and intervention use, providing support if needed. Researchers will analyze repeated measurements over time to assess effects and conduct exit interviews on intervention acceptability. The total participation lasts six months with ongoing data collection and support to understand how YCWS may impact stress, pain, and opioid use in adults with SCD.
CONDITIONS
Brief Title
A Stress and Pain Self-management m-Health App for Adult Outpatients With Sickle Cell Disease
Who Can Participate
Age: 18Years - 99Years
All Genders
Eligibility Criteria
You may qualify if you...
- Diagnosis of sickle cell disease (e.g., HbSS, HbSC, HbS-beta-0 thalassemia, HbS-beta+ thalassemia)
- Reports moderate to severe pain (greater than 3 on 0-10 scale) related to sickle cell disease within the past 24 hours
- Uses opioid pain medications either as needed or continuously
- Ability to speak and read English
- Age 18 years or older
You will not qualify if you...
- Legally blind
- Physically unable to complete study procedures
- Previously participated in the relaxation/distraction intervention feasibility study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote)
Treatment
Duration - 8 weeks
Participants will monitor their stress, pain, and opioid use daily using a mobile app. The experimental group will also use video banks and receive support via the YCWS app, while the control group will receive alerts and reminders only. Study staff will provide support if participants miss data entry.
Daily self-monitoring with automated alerts; support contacts as needed
Long-term Monitoring
Duration - 4 months (Months 3-6)
Participants continue daily monitoring of stress, pain, and opioid use with automated alerts. Experimental group participants retain access to video banks for personal use without active support.
Daily self-monitoring with automated alerts
Trial Site Locations
Total: 1 location
1
University of Florida
Gainesville, Florida, United States, 32610
Actively Recruiting
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Research Team
M
Muntaha Ali, MS
A
Amelia Greenlee
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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