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YCWS App for Sickle Cell Disease

N/A

Recruiting

Led By Miriam O. Ezenwa

Research Sponsored by University of Florida

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Is 18 years of age or older

Reports moderate to severe level of pain (>3 on 0-10 scale) related to SCD within previous 24 hours

Must not have

Legally blind

Physically unable to complete procedures

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline through month 6

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether the You Cope, We Support intervention can help reduce stress and improve pain control in patients with sickle cell disease, while reducing opioid use.

Who is the study for?

This trial is for English-speaking adults over 18 with Sickle Cell Disease (SCD) who experience moderate to severe pain and use opioids. It's not for those who are legally blind, physically unable to complete the study tasks, or have been in a related feasibility study before.

What is being tested?

The trial tests a mobile health app that helps manage stress and pain through self-monitoring and provides relaxation/distraction exercises called 'You Cope, We Support' (YCWS). Participants will either use the full YCWS program or just self-monitor with alerts/reminders.

What are the potential side effects?

Since this intervention involves non-invasive techniques like monitoring and educational content rather than medication, significant side effects are not expected. However, users may experience discomfort from regular engagement with technology.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have experienced pain level above 3 due to SCD in the last 24 hours.

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I have been diagnosed with sickle cell disease.

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I use opioid painkillers as needed or regularly.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am legally blind.

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I cannot physically undergo the procedures required.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline through month 6

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline through month 6

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through month 6 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Opioid use

Pain intensity scale

Stress intensity scale

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Experimental GroupExperimental Treatment1 Intervention

(Self-monitoring of pain, stress, and opioid use + alerts/reminders + use of YCWS \[three video banks of RDE + Support\]). Self-monitoring, using video banks, and getting support elements comprise the YCWS intervention. The YCWS App is comprised of three tabs displayed across the top of the screen, namely, self-monitoring, video banks, and support. During the short-term trial (Weeks 1-8), patients will monitor their stress and pain daily and have access to three video banks from which to choose their daily intervention. We will send automated system-generated alerts/reminders every 24 hours to experimental group patients via phone call, text, or email to facilitate intervention use. During the long-term period (months 3-6), only system-generated alerts/reminders will be available.

Group II: Control GroupActive Control1 Intervention

(Self-monitoring of pain, stress, and opioid use + alerts/reminders). During efficacy trial (Weeks 1-8), patients will monitor their stress, pain, and opioid use daily. We will send system-generated alerts/reminders every 24 hours to patients via phone call, text, or email to facilitate data entry. During the long-term period (months 3-6), patients will continue to monitor their stress, pain, and opioid use daily and receive only system generated alerts/reminders via messaging service or staff cell phone.

0 / 6Eligibility criteria met