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Stress and Pain Self-management App for Sickle Cell Disease

This study is testing a mobile app called "You Cope, We Support" (YCWS) designed to help adults with sickle cell disease (SCD) manage their pain and stress, and potentially reduce opioid use. The app includes self-monitoring tools for pain, stress, and opioid use, along with alerts, reminders, and videos with relaxation and distraction exercises. Researchers want to see if using YCWS can improve pain intensity, stress levels, and opioid use over 6 months. You might be able to join if you are an adult (18-99 years old) with a diagnosis of SCD, experience moderate to severe pain, use opioid pain medication, and can speak and read English. The study aims to enroll 185 participants.

Study design
This study is a randomized controlled trial, meaning participants will be randomly assigned to one of two groups. It plans to enroll 185 adult outpatients.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 6 months after starting the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04484272

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

Completed
NAAges 18–99InterventionalTreatment
University of Florida
~239 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:Self-monitoring of pain, stress, and opioid use + alerts/reminders + use of YCWS. [three video banks of RDE + Support]).Self-monitoring of pain, stress, and opioid use + alerts/reminders.

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Stress intensity scale
Measured over Baseline through Month 6
+2 more outcomes measured

Conditions

Sickle Cell Disease

Explore related trials

Sickle Cell Disease

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Miriam O. Ezenwa · PRINCIPAL_INVESTIGATOR · University of Florida

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

are legally blind; (b) physically unable to complete procedures; (c) previously participated in our relaxation/distraction intervention feasibility study

What this trial measures

  • Stress intensity scaleBaseline through Month 6

    This 3-item scale asks patients to report their current, least, and worst stress intensity in the past 24 hours, on a scale of 0 (no stress) to 10 (stress as bad as it could be)

  • Pain intensity scaleBaseline through Month 6

    Pain intensity Scale. This 3-item scale asks patients to report their current, least, and worst pain intensity in the past 24 hours, on a scale of 0 (no pain) to 10 (pain as bad as it could be).

  • Opioid useBaseline through Month 6

    We will use PAINReportIt®87-89 software program (Nursing Consult LLC, Seattle, WA) to collect data on names and doses of scheduled and as needed (PRN) opioid analgesics at baseline and updated at Week 8 and 6 month. We will use Wisepill medication event monitoring system (MEMS) to collect data on opioid use.