Hybrid Effectiveness-Implementation Trial of Guided Relaxation and Acupuncture for Chronic Sickle Cell Disease Pain
GRACE
2 other identifiers
interventional
379
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2021
Typical duration for phase_2
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 28, 2021
CompletedFirst Posted
Study publicly available on registry
May 28, 2021
CompletedStudy Start
First participant enrolled
November 24, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 2, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2026
CompletedMarch 3, 2026
March 1, 2025
3.5 years
April 28, 2021
February 27, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
PROMIS Pain Interference
Scores range from 4-20; higher scores indicate that pain is interfering with daily activities more
From Baseline to 24 weeks
Pain, Enjoyment of Life and General Activity scale (PEG)
0-10 rating on pain intensity, enjoyment of life and general activity
From Baseline to 24 weeks
PROMIS Physical Function
4-20 rating on the impact of pain on ability to perform normal activities; higher scores indicate greater impact of pain on physical function
From Baseline to 24 weeks
Secondary Outcomes (8)
Generalised Anxiety Disorder Questionnaire (GAD-7)
From Baseline to 24 weeks
Patient Health Questionnaire Depression Scale (PHQ)
From Baseline to 24 weeks
PROMIS sleep disturbance 8a
From Baseline to 24 weeks
Sleep duration
From Baseline to 24 weeks
Pain Catastrophizing Scale (PCS)
From Baseline to 24 weeks
- +3 more secondary outcomes
Study Arms (3)
Control arm
NO INTERVENTIONParticipants randomized to the control arm will receive usual care
Acupuncture
EXPERIMENTALAcupuncture treatments twice a week for five weeks
Guided Relaxation
EXPERIMENTALDaily use of a guided relaxation app for 6 weeks
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Diagnosis of sickle cell disease based on hemoglobin electrophoresis
- Provision of signed and dated informed consent form
- Able to speak and understand English
- Chronic pain, defined as a response of "Some days," "Most days" or "Every day" to the question, "In the past 3 months, how often have you had pain?" (Answer options: Never, Some days, Most days, Every day)
- Current pain interference using the general activity question from PEG, score ≥3 on 0-10 scale
You may not qualify if:
- Has had a stem cell transplant for sickle cell disease
- Current incarceration
- Any other condition that the investigator considers precludes participation in the clinical trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitycollaborator
- National Center for Complementary and Integrative Health (NCCIH)collaborator
- University of Illinois at Chicagolead
- University of Floridacollaborator
Study Sites (5)
University of Florida
Gainesville, Florida, 32610, United States
Emory University
Atlanta, Georgia, 30322, United States
University of Illinois at Chicago
Chicago, Illinois, 60612, United States
Johns Hopkins University
Baltimore, Maryland, 21218, United States
Duke University
Durham, North Carolina, 22710, United States
Related Publications (2)
Knisely MR, Rivera E, deMartelly VA, Abdulkadir A, Doorenbos AZ, Ezenwa MO, Molokie RE, Li H, Shah N, Schlaeger JM, Patil CL. Developing an Implementation Blueprint for the NIH HEAL Initiative GRACE Trial: Perspectives on Acupuncture and Guided Relaxation for Chronic Sickle Cell Disease Pain. J Integr Complement Med. 2023 Oct;29(10):683-688. doi: 10.1089/jicm.2022.0781. Epub 2023 May 15.
PMID: 37184905DERIVEDDoorenbos AZ, Schlaeger JM, deMartelly VA, Burke LA, Boyd AD, Knisely MR, Leigh JW, Li H, Mandernach MW, Molokie RE, Patil CL, Steffen AD, Shah N, Ezenwa MO. Hybrid effectiveness-implementation trial of guided relaxation and acupuncture for chronic sickle cell disease pain (GRACE): A protocol. Contemp Clin Trials Commun. 2023 Jan 18;32:101076. doi: 10.1016/j.conctc.2023.101076. eCollection 2023 Apr.
PMID: 36852100DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ardith Doorenbos, PhD, RN, FAAN
University of Illinois at Chicago
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor in the Department of Biobehavioral Health Science, College of Nursing
Study Record Dates
First Submitted
April 28, 2021
First Posted
May 28, 2021
Study Start
November 24, 2021
Primary Completion
June 2, 2025
Study Completion
February 28, 2026
Last Updated
March 3, 2026
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
- Time Frame
- Data will be shared within one year of the completion of the study.
- Access Criteria
- The data and associated documentation will be made available to users only under a data-sharing agreement that provides for (a) a commitment to using the data only for research purposes and not to identify any individual patient; (b) a commitment to securing the data using appropriate computer technology; and (c) a commitment to destroying or returning the data after analyses are completed. Such a data-use agreement will be executed through the PIs and the University of Illinois at Chicago College of Nursing. The database can then be accessed via our secure website, in a format that can be used by a variety of statistical software packages. We will make our data and results publicly available (predominately online), so that they can easily be found.
We will publish our results in open-source manuscripts that will be available to the public. Electronic copies of publications will be deposited in PubMed Central with proper tagging of metadata to ensure online discoverability and accessibility within four weeks of acceptance by a journal. To the extent feasible, Underlying Primary Data will be shared simultaneously with the publication and made immediately accessible through release under the Creative Commons Attribution 4.0 Generic License or an equivalent license, or otherwise dedicated to the public domain. Before submitting Underlying Primary Data, we will work with our Institutional Review Board (IRB) and Data Safety and Monitoring Board to assess the informed consent materials and to determine whether the Underlying Primary Data may be shared as contemplated in this policy.