Hybrid Effectiveness-Implementation Trial of Guided Relaxation and Acupuncture for Chronic Sickle Cell Disease Pain
- Conditions
- Sickle Cell Disease
- Interventions
- Behavioral: Guided RelaxationOther: Acupuncture
- Registration Number
- NCT04906447
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 379
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Guided Relaxation Guided Relaxation Daily use of a guided relaxation app for 6 weeks Acupuncture Acupuncture Acupuncture treatments twice a week for five weeks
- Primary Outcome Measures
Name Time Method PROMIS Pain Interference 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) From Baseline to 24 weeks 0-10 rating on pain intensity, enjoyment of life and general activity
PROMIS Physical Function 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
Name Time Method PROMIS sleep disturbance 8a From Baseline to 24 weeks 8-40 rating with higher scores indicating greater severity of sleep disturbance
Patient's Global Impression of Change (PGIC) From Baseline to 24 weeks 1-7 scale with higher scores indicating more improvement in pain from the patient's perspective
Generalised Anxiety Disorder Questionnaire (GAD-7) 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) 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.
Tobacco, Alcohol, Prescription medication, and other Substance use (TAPS1) From Baseline to 24 weeks 1-20 scale with higher score relating to more frequent substance use over the past 12 months
Sleep duration From Baseline to 24 weeks Hours a participant has slept
Pain Catastrophizing Scale (PCS) From Baseline to 24 weeks 0-52 scale with higher scores indicating more catastrophizing thoughts are present
Gastrointestinal Constipation 9a From Baseline to 24 weeks 9-45 scale with higher scores indicating more severe constipation symptoms
Trial Locations
- Locations (5)
University of Florida
🇺🇸Gainesville, Florida, United States
Emory University
🇺🇸Atlanta, Georgia, United States
University of Illinois at Chicago
🇺🇸Chicago, Illinois, United States
Johns Hopkins University
🇺🇸Baltimore, Maryland, United States
Duke University
🇺🇸Durham, North Carolina, United States