Sickle Cell Disease
Conditions
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.
Interventions
BEHAVIORALGuided 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.
OTHERAcupuncture
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.
Sponsors
University of Illinois at Chicago
University of Florida
Duke University
National Center for Complementary and Integrative Health (NCCIH)
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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 "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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| PROMIS sleep disturbance 8a | From Baseline to 24 weeks | 8-40 rating with higher scores indicating greater severity of sleep disturbance |
| 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 |
| 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 |
| 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 |
| Gastrointestinal Constipation 9a | From Baseline to 24 weeks | 9-45 scale with higher scores indicating more severe constipation symptoms |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORArdith Doorenbos, PhD, RN, FAAN
University of Illinois at Chicago
Outcome results
None listed