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/35904878/Actively Recruiting
Led by University of Florida · Updated on 2025-08-01
185
Participants Needed
1
Research Sites
N/A
Total Duration
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 alertsreminders, 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
A Stress and Pain Self-management m-Health App for Adult Outpatients With Sickle Cell Disease
M
Muntaha Ali, MS
A
Amelia Greenlee
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University of Florida
Lead Sponsor
National Institute of Nursing Research (NINR)
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Self-monitoring + YCWS video banks | Self-monitoring only |
|---|---|---|
| What it is | A behavioral intervention combining self-monitoring of pain, stress, and opioid use with alerts, reminders, and YCWS video banks for relaxation and distraction support. | A behavioral intervention providing self-monitoring of pain, stress, and opioid use with alerts and reminders, but without YCWS video banks. |
| Role in the trial | Experimental arm testing whether adding YCWS video-based support improves stress and pain outcomes compared to self-monitoring alone. | Active comparator arm evaluating self-monitoring without YCWS video support. |
| Primary use or goal | To reduce stress and pain intensity and opioid use among adults with sickle cell disease by combining self-monitoring and video-guided relaxation/distraction. | To reduce stress and pain intensity and opioid use through self-monitoring and alerts without video-based support. |
| How it is given or performed | Participants use a mobile app to track pain, stress, and opioid use, receive alerts/reminders, and access video banks for relaxation and distraction, completing tasks on their own devices. | Participants use a mobile app to record pain, stress, and opioid use, and receive alerts/reminders but do not access YCWS videos. |
| Evidence status | Clinical outcomes for this intervention are not yet established; results will depend on trial findings. Existing evidence is limited to feasibility or protocol reports. | Clinical outcomes for self-monitoring alone are not yet established for sickle cell disease. Published protocol supports evaluation but lacks outcome data. |
| Important limitations | As a digital self-management intervention, effectiveness and long-term benefit are unproven. Trial relies on participant engagement, which may vary, and app-based interventions may not fully address complex pain and stress in sickle cell disease. | The app-only approach without video support may limit effectiveness. Long-term outcomes and patient adherence are not established. Digital self-monitoring alone may not address multifaceted stress and pain. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote)
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
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
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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Miriam O Ezenwa, Yingwei Yao, Molly W Mandernach...
https://pubmed.ncbi.nlm.nih.gov/35904878/University of Florida
Lead Sponsor
National Institute of Nursing Research (NINR)
Collaborating Sponsor