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NCT04484272 · ClinicalTrials.gov registry record · NA
A Stress and Pain Self-management m-Health App for Adult Outpatients With Sickle Cell Disease
A NA study of Sickle Cell Disease, sponsored by University of Florida.
- Recruiting
- Registry status
- NA
- Development phase
- 185
- Enrollment target
- 1
- Study location
NCT04484272 is a NA study of Sickle Cell Disease that is actively recruiting participants, run by University of Florida. The registered enrollment target is 185 participants, below the 292-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (37% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04484272, a NA study of Sickle Cell Disease, is actively recruiting participants, sponsored by University of Florida.
- RECRUITING
- Registry status
- NA
- Development phase
- 185 participants
- Enrollment target
- 1
- Study location
Study Summary
Our long-term goal is to reduce stress and improve sickle cell disease (SCD) pain control with less opioid use through an intervention with self-management relaxation/distraction exercises (RDE), named You Cope, We Support (YCWS). Americans living with SCD suffer recurrent episodes of acute and chronic pain, both of which are exacerbated by stress. Building on the successes of our prior formative studies, we now propose a well-designed, appropriately powered study to test efficacy of YCWS on outcomes (pain intensity, stress intensity, opioid use) in adults with SCD. We propose to recruit 170 adults for a randomized controlled trial of the short-term (8 weeks) and long-term (6 months) effects of YCWS on outcomes (pain, stress, and opioid use). Stratified on worst pain intensity (\<=5; \>5), we will randomly assign patients to groups: 85 to Control (Self-monitoring of outcomes + alerts/reminders), and 85 to Experimental (Self-monitoring of outcomes + alerts/reminders + use of YCWS \[RDE + Support\]). We will ask participants to report outcomes daily. During weeks 1-8, we will send system-generated alerts/reminders to both groups via phone call, text, or email to facilitate data entry (both groups) and intervention use support (experimental). If the patient does not enter data after 24 hours, study support staff will contact him/her for data entry trouble-shooting (both groups) and YCWS use (experimental). We will time stamp and track participants' online activities to understand the study context and conduct exit interviews on acceptability of the staff and system-generated support. We will analyze data using mixed-effects regression models (short-term, long-term) to account for repeated measurements over time and utilize machine learning to construct and evaluate models predictive of outcomes. Specific aims are: Aim 1: To determine the short-term effects of YCWS. Aim 2: To determine the long-term effects of YCWS. Aim 3 (exploratory): Using machine learning, to develo
Conditions Studied
Interventions
- BEHAVIORAL Self-monitoring of pain, stress, and opioid use + alerts/reminders + use of YCWS. [three video banks of RDE + Support]).
- BEHAVIORAL Self-monitoring of pain, stress, and opioid use + alerts/reminders.
Study Locations (1)
Florida
- University of Florida - Gainesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 185 participants |
| Start Date | 2021-04-29 |
| Est. Completion | 2026-06-30 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04484272
The ClinicalTrials.gov registry entry for NCT04484272 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 185 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 292-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (37% lower). The listed sponsor is University of Florida, which has 1,106 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Sickle Cell Disease appearing as the primary indexed condition, and to 2 interventions - of which Self-monitoring of pain, stress, and opioid use + alerts/reminders + use of YCWS. [three video banks of RDE + Support]). is the first listed.
NCT04484272 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.
Frequently Asked Questions
What is clinical trial NCT04484272 about?
NCT04484272 is a clinical study titled "A Stress and Pain Self-management m-Health App for Adult Outpatients With Sickle Cell Disease". Our long-term goal is to reduce stress and improve sickle cell disease (SCD) pain control with less opioid use through an intervention with self-management relaxation/distraction exercises (RDE), named You Cope, We Support (YCWS). Americans living with SCD suffer recurrent episodes of acute and chro...
What is the current status of trial NCT04484272?
This trial is currently recruiting. It is a NA study. The enrollment target is 185 participants. The study started on 2021-04-29. Estimated completion is 2026-06-30.
What conditions does trial NCT04484272 study?
This clinical trial studies the following conditions: Sickle Cell Disease.
What interventions are being tested in trial NCT04484272?
The interventions under investigation include: Self-monitoring of pain, stress, and opioid use + alerts/reminders + use of YCWS. [three video banks of RDE + Support]). (BEHAVIORAL), Self-monitoring of pain, stress, and opioid use + alerts/reminders. (BEHAVIORAL).
Who is sponsoring clinical trial NCT04484272?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04484272 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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