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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline through month 6

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Opioid use

Pain intensity scale

Stress intensity scale

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 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute of Nursing Research (NINR)NIH

581 Previous Clinical Trials

10,376,490 Total Patients Enrolled

University of FloridaLead Sponsor

1,343 Previous Clinical Trials

716,288 Total Patients Enrolled

Miriam O. EzenwaPrincipal InvestigatorUniversity of Florida

Media Library

Self-monitoring of pain, stress, and opioid use + alerts/reminders Clinical Trial Eligibility Overview. Trial Name: NCT04484272 — N/A

Sickle Cell Disease Research Study Groups: Control Group, Experimental Group

Sickle Cell Disease Clinical Trial 2023: Self-monitoring of pain, stress, and opioid use + alerts/reminders Highlights & Side Effects. Trial Name: NCT04484272 — N/A

Self-monitoring of pain, stress, and opioid use + alerts/reminders 2023 Treatment Timeline for Medical Study. Trial Name: NCT04484272 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment for this experiment still open to participants?

"Affirmative. As per the information on clinicaltrials.gov, this trial is actively recruiting patients and was first listed on April 29th 2021. Following the most recent update posted on September 13th 2022, 185 individuals from a single site are sought to participate in this experiment."

Answered by AI

Who is permitted to participate in this clinical examination?

"For eligibility in this trial, candidates must be aged between 18 and 99 with anemia or sickle cell. Approximately 185 individuals will gain admittance to the study."

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Does this experiment accept participants aged over 60?

"This clinical trial is open to applicants aged 18-99. However, there are separate trials for those under 18 (131) and people over 65 (86)."

Answered by AI

What is the maximum allowable cohort size for this clinical trial?

"Affirmative. On clinicaltrials.gov, this medical trial is stated to be in the process of enrollment. The study was initially published on April 29th 2021 and last modified on September 13th 2022. A total of 185 participants from a single site are needed for the research project to proceed."

Answered by AI

Recent research and studies

JMIR Research ProtocolsJournal

A Stress and Pain Self-management Mhealth App for Adult Outpatients with Sickle Cell Disease: Protocol for a Randomized Controlled Study

Ezenwa, Miriam O, Yingwei Yao, Molly W Mandernach, David A Fedele, Robert J Lucero, Inge Corless, Brenda W Dyal, Mary H Belkin, Abhinav Rohatgi, and Diana J Wilkie. 2022. “A Stress and Pain Self-management Mhealth App for Adult Outpatients with Sickle Cell Disease: Protocol for a Randomized Controlled Study”. JMIR Research Protocols. JMIR Publications Inc.. doi:10.2196/33818.

clinicaltrials.govStudy

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

2021. "A Stress and Pain Self-management m-Health App for Adult Outpatients With Sickle Cell Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04484272.

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