Ignite Creation Date:
2024-05-06 @ 4:12 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04906447
Status:
RECRUITING
Last Update Posted:
2024-06-24
First Post:
2021-04-28
Brief Title:
Hybrid Effectiveness-Implementation Trial of Guided Relaxation and Acupuncture for Chronic Sickle Cell Disease Pain
Sponsor:
University of Illinois at Chicago
Organization:
University of Illinois at Chicago
Study Overview
Official Title:
Hybrid Effectiveness-Implementation Trial of Guided Relaxation and Acupuncture for Chronic Sickle Cell Disease Pain
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GRACE
Brief 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 1 initiate guided relaxation and switch to acupuncture for non-responders at midpoint 2 initiate guided relaxation and continue with guided relaxation for non-responders at midpoint 3 initiate acupuncture and switch to guided relaxation for non-responders at midpoint or 4 initiate acupuncture and continue with acupuncture for non-responders at midpoint
Aim 3 Explore differences in response to the adaptive interventions by age and sex
Aim 4 Identify implementation facilitators challenges and solutions for structures and processes that contribute to the seamless integration of CIH therapies into the 3 health systems by conducting individual interviews with participants in the intervention group who responded to the intervention and those who did not The investigators will also conduct focus groups with hospital personnel at 4 timepoints
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 1 initiate guided relaxation and switch to acupuncture for non-responders at midpoint 2 initiate guided relaxation and continue with guided relaxation for non-responders at midpoint 3 initiate acupuncture and switch to guided relaxation for non-responders at midpoint or 4 initiate acupuncture and continue with acupuncture for non-responders at midpoint
Aim 3 Explore differences in response to the adaptive interventions by age and sex
Aim 4 Identify implementation facilitators challenges and solutions for structures and processes that contribute to the seamless integration of CIH therapies into the 3 health systems by conducting individual interviews with participants in the intervention group who responded to the intervention and those who did not The investigators will also conduct focus groups with hospital personnel at 4 timepoints
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1UG3AT011265-01 | NIH | None | httpsreporternihgovquickSearch1UG3AT011265-01 |