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| ID | Type | Description | Link |
|---|---|---|---|
| 1UG3AT011265-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Florida | OTHER |
| Duke University | OTHER |
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control arm | No Intervention | Participants randomized to the control arm will receive usual care | |
| Acupuncture | Experimental | Acupuncture treatments twice a week for five weeks |
|
| Guided Relaxation | Experimental | Daily use of a guided relaxation app for 6 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Guided Relaxation | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Generalised Anxiety Disorder Questionnaire (GAD-7) | Measure of Anxiety with scores ranging from 0-21. Higher scores indicate higher levels of anxiety. | From Baseline to 24 weeks |
| Patient Health Questionnaire Depression Scale (PHQ) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ardith Doorenbos, PhD, RN, FAAN | University of Illinois at Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32610 | United States | ||
| Emory University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37184905 | Derived | 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. | |
| 36852100 | Derived | Doorenbos 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. |
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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.
Data will be shared within one year of the completion of the study.
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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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 15, 2022 |
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| Acupuncture | Other | 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. |
|
0-24 rating of depression. 10 or greater total is considered major depression, 20 or more is severe major depression.
| From Baseline to 24 weeks |
| PROMIS sleep disturbance 8a | 8-40 rating with higher scores indicating greater severity of sleep disturbance | From Baseline to 24 weeks |
| Sleep duration | Hours a participant has slept | From Baseline to 24 weeks |
| Pain Catastrophizing Scale (PCS) | 0-52 scale with higher scores indicating more catastrophizing thoughts are present | From Baseline to 24 weeks |
| Patient's Global Impression of Change (PGIC) | 1-7 scale with higher scores indicating more improvement in pain from the patient's perspective | From Baseline to 24 weeks |
| Tobacco, Alcohol, Prescription medication, and other Substance use (TAPS1) | 1-20 scale with higher score relating to more frequent substance use over the past 12 months | From Baseline to 24 weeks |
| Gastrointestinal Constipation 9a | 9-45 scale with higher scores indicating more severe constipation symptoms | From Baseline to 24 weeks |
| 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 |
| Sep 23, 2022 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 19, 2022 | Sep 23, 2022 | ICF_001.pdf |
| ID | Term |
|---|---|
| D000755 | Anemia, Sickle Cell |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D015670 | Acupuncture Therapy |
| ID | Term |
|---|---|
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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