Hybrid Effectiveness-Implementation Trial of Guided Relaxation and Acupuncture for Chronic Sickle Cell Disease Pain (GRACE)
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|ClinicalTrials.gov Identifier: NCT04906447|
Recruitment Status : Recruiting
First Posted : May 28, 2021
Last Update Posted : June 22, 2022
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.
|Condition or disease||Intervention/treatment||Phase|
|Sickle Cell Disease||Behavioral: Guided Relaxation Other: Acupuncture||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||366 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Hybrid Effectiveness-Implementation Trial of Guided Relaxation and Acupuncture for Chronic Sickle Cell Disease Pain|
|Actual Study Start Date :||November 22, 2021|
|Estimated Primary Completion Date :||March 30, 2025|
|Estimated Study Completion Date :||August 30, 2025|
No Intervention: Control arm
Participants randomized to the control arm will receive usual care
Acupuncture treatments twice a week for five weeks
Acupuncture is a body-based therapy that includes the insertion of thin needles at strategic points on the body that has been proven effective for reducing pain.
Experimental: Guided Relaxation
Daily use of a guided relaxation app for 6 weeks
Behavioral: Guided Relaxation
Guided relaxation uses the mind to reduce pain, promote well-being, and improve physical function. Guided relaxation is a state of concentration and focused attention that gives people more control over their pain experience and its impact and an increased sense of well-being.
- PROMIS Pain Interference [ Time Frame: From Baseline to 24 weeks ]Scores range from 4-20; higher scores indicate that pain is interfering with daily activities more
- Pain, Enjoyment of Life and General Activity scale (PEG) [ Time Frame: From Baseline to 24 weeks ]0-10 rating on pain intensity, enjoyment of life and general activity
- PROMIS Physical Function [ Time Frame: From Baseline to 24 weeks ]4-20 rating on the impact of pain on ability to perform normal activities; higher scores indicate greater impact of pain on physical function
- Generalised Anxiety Disorder Questionnaire (GAD-7) [ Time Frame: From Baseline to 24 weeks ]Measure of Anxiety with scores ranging from 0-21. Higher scores indicate higher levels of anxiety.
- Patient Health Questionnaire Depression Scale (PHQ) [ Time Frame: From Baseline to 24 weeks ]0-24 rating of depression. 10 or greater total is considered major depression, 20 or more is severe major depression.
- PROMIS sleep disturbance 8a [ Time Frame: From Baseline to 24 weeks ]8-40 rating with higher scores indicating greater severity of sleep disturbance
- Sleep duration [ Time Frame: From Baseline to 24 weeks ]Hours a participant has slept
- Pain Catastrophizing Scale (PCS) [ Time Frame: From Baseline to 24 weeks ]0-52 scale with higher scores indicating more catastrophizing thoughts are present
- Patient's Global Impression of Change (PGIC) [ Time Frame: From Baseline to 24 weeks ]1-7 scale with higher scores indicating more improvement in pain from the patient's perspective
- Tobacco, Alcohol, Prescription medication, and other Substance use (TAPS1) [ Time Frame: From Baseline to 24 weeks ]1-20 scale with higher score relating to more frequent substance use over the past 12 months
- Gastrointestinal Constipation 9a [ Time Frame: From Baseline to 24 weeks ]9-45 scale with higher scores indicating more severe constipation symptoms
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04906447
|Contact: Ardith Doorenbos, PhD, RN, FAANfirstname.lastname@example.org|
|Contact: Victoria deMartelly, MPHemail@example.com|
|United States, Florida|
|University of Florida||Recruiting|
|Gainesville, Florida, United States, 32610|
|Contact: Miriam Ezenwa, PhD, RN, FAAN firstname.lastname@example.org|
|United States, Illinois|
|University of Illinois at Chicago||Recruiting|
|Chicago, Illinois, United States, 60612|
|Contact: Ardith Doorenbos, PhD, RN, FAAN|
|United States, North Carolina|
|Durham, North Carolina, United States, 22710|
|Contact: Nirmish Shah, MD email@example.com|
|Principal Investigator:||Ardith Doorenbos, PhD, RN, FAAN||University of Illinois at Chicago|