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NCT04906447 · ClinicalTrials.gov registry record · Phase 2
Hybrid Effectiveness-Implementation Trial of Guided Relaxation and Acupuncture for Chronic Sickle Cell Disease Pain
A Phase 2 study, sponsored by University of Illinois at Chicago.
- Completed
- Registry status
- Phase 2
- Development phase
- 379
- Enrollment target
NCT04906447 is a Phase 2 study that has completed, run by University of Illinois at Chicago. The registered enrollment target is 379 participants.
The verdict
NCT04906447, a Phase 2 study, has completed, sponsored by University of Illinois at Chicago.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 379 participants
- Enrollment target
Study Summary
The investigators will conduct a hybrid type 1 effectiveness implementation trial to assess the effectiveness of acupuncture and guided relaxation on 360 people with Sickle Cell Disease (SCD), while observing and gathering information on implementation in three health systems: University of Illinois Hospital \& Health Sciences System, University of Florida Health, and Duke University Health Systems. Each serves a large population with SCD, uses EPIC as their electronic health record, and has a Clinical and Translational Science Award (CTSA), which will help speed the translation of discovery into improved patient care. During the UH3 Implementation Phase, the 3-arm, 3-site randomized controlled trial will follow a quantitative modified SMART design, a pragmatic trial that evaluates adaptive interventions where the guided relaxation and acupuncture interventions respond to patients' characteristics and evolving pain status. The investigators rely on the Consolidated Framework for Implementation Research (CFIR) to plan, execute, and evaluate associated implementation processes. The use of complementary and integrative health (CIH) therapies by those with SCD to reduce pain and opioid use, to help enable them to better cope with their pain, is well known, but there are few studies that evaluate the effectiveness of these therapies, and none that also evaluates the implementation across multiple health care systems and patient populations as this study will. Aim 1: Determine the effectiveness of guided relaxation and acupuncture as compared to usual care in decreasing pain and opioid use for SCD patients. Hypothesis: At 6-weeks, SCD patients randomized to either CIH intervention will have a greater decrease in pain, opioid use, sleep, anxiety, depressive symptoms, and pain catastrophizing compared to SCD patients randomized to usual care. Aim 2: Identify the best adaptive intervention for improved outcomes by documenting outcomes among adaptive intervention sequences:
Interventions
- OTHER Acupuncture
- BEHAVIORAL Guided Relaxation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 379 participants |
| Start Date | 2021-11-24 |
| Est. Completion | 2026-02-28 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04906447
The ClinicalTrials.gov registry entry for NCT04906447 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 379 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Illinois at Chicago, which has 430 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Acupuncture is the first listed.
NCT04906447 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04906447 about?
NCT04906447 is a clinical study titled "Hybrid Effectiveness-Implementation Trial of Guided Relaxation and Acupuncture for Chronic Sickle Cell Disease Pain". The investigators will conduct a hybrid type 1 effectiveness implementation trial to assess the effectiveness of acupuncture and guided relaxation on 360 people with Sickle Cell Disease (SCD), while observing and gathering information on implementation in three health systems: University of Illinois...
What is the current status of trial NCT04906447?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 379 participants. The study started on 2021-11-24. Estimated completion is 2026-02-28.
What interventions are being tested in trial NCT04906447?
The interventions under investigation include: Acupuncture (OTHER), Guided Relaxation (BEHAVIORAL).
Who is sponsoring clinical trial NCT04906447?
This trial is sponsored by University of Illinois at Chicago, which has 430 total clinical trials registered on ClinicalTrials.gov.
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