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Hybrid Effectiveness-Implementation Trial of Guided Relaxation and Acupuncture for Chronic Sickle Cell Disease Pain (GRACE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04906447
Recruitment Status : Recruiting
First Posted : May 28, 2021
Last Update Posted : June 22, 2022
Sponsor:
Collaborators:
University of Florida
Duke University
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Ardith Doorenbos, University of Illinois at Chicago

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.


Condition or disease Intervention/treatment Phase
Sickle Cell Disease Behavioral: Guided Relaxation Other: Acupuncture Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 366 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture

Arm Intervention/treatment
No Intervention: Control arm
Participants randomized to the control arm will receive usual care
Experimental: Acupuncture
Acupuncture treatments twice a week for five weeks
Other: Acupuncture
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.




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. PROMIS sleep disturbance 8a [ Time Frame: From Baseline to 24 weeks ]
    8-40 rating with higher scores indicating greater severity of sleep disturbance

  4. Sleep duration [ Time Frame: From Baseline to 24 weeks ]
    Hours a participant has slept

  5. Pain Catastrophizing Scale (PCS) [ Time Frame: From Baseline to 24 weeks ]
    0-52 scale with higher scores indicating more catastrophizing thoughts are present

  6. 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

  7. 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

  8. Gastrointestinal Constipation 9a [ Time Frame: From Baseline to 24 weeks ]
    9-45 scale with higher scores indicating more severe constipation symptoms



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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 "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

Exclusion Criteria:

  • Has had a stem cell transplant for sickle cell disease
  • A known diagnosis of moderate or severe opioid use disorder by Diagnostic and Statistical Manual of Mental Disorders-5 criteria
  • Current incarceration
  • Patients who are on a chronic transfusion/exchange program
  • Any other condition that the investigator considers precludes participation in the clinical trial

Information from the National Library of Medicine

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


Contacts
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Contact: Ardith Doorenbos, PhD, RN, FAAN 312-996-2817 ardith@uic.edu
Contact: Victoria deMartelly, MPH vdemar2@uic.edu

Locations
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United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32610
Contact: Miriam Ezenwa, PhD, RN, FAAN       moezenwa@ufl.edu   
United States, Illinois
University of Illinois at Chicago Recruiting
Chicago, Illinois, United States, 60612
Contact: Ardith Doorenbos, PhD, RN, FAAN         
United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 22710
Contact: Nirmish Shah, MD       nirmish.shah@duke.edu   
Sponsors and Collaborators
University of Illinois at Chicago
University of Florida
Duke University
National Center for Complementary and Integrative Health (NCCIH)
Investigators
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Principal Investigator: Ardith Doorenbos, PhD, RN, FAAN University of Illinois at Chicago
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Responsible Party: Ardith Doorenbos, Professor in the Department of Biobehavioral Health Science, College of Nursing, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT04906447    
Other Study ID Numbers: 2021-0124
1UG3AT011265-01 ( U.S. NIH Grant/Contract )
First Posted: May 28, 2021    Key Record Dates
Last Update Posted: June 22, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn