Clinical trial NCT04906447: Hybrid Effectiveness-Implementation Trial of Guided Relaxation and Acupuncture for Chronic Sickle Cell Disease Pain
Official title: Hybrid Effectiveness-Implementation Trial of Guided Relaxation and Acupuncture for Chronic Sickle Cell Disease Pain
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Sickle Cell Disease
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: University of Florida
name: Duke University
name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2021-05-28
Enrollment: 379
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility 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 "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

Primary outcomes:
measure: PROMIS Pain Interference
timeFrame: From Baseline to 24 weeks
measure: Pain, Enjoyment of Life and General Activity scale (PEG)
timeFrame: From Baseline to 24 weeks
measure: PROMIS Physical Function
timeFrame: From Baseline to 24 weeks
Secondary outcomes:
measure: Generalised Anxiety Disorder Questionnaire (GAD-7)
timeFrame: From Baseline to 24 weeks
measure: Patient Health Questionnaire Depression Scale (PHQ)
timeFrame: From Baseline to 24 weeks
measure: PROMIS sleep disturbance 8a
timeFrame: From Baseline to 24 weeks
measure: Sleep duration
timeFrame: From Baseline to 24 weeks
measure: Pain Catastrophizing Scale (PCS)
timeFrame: From Baseline to 24 weeks
measure: Patient's Global Impression of Change (PGIC)
timeFrame: From Baseline to 24 weeks
measure: Tobacco, Alcohol, Prescription medication, and other Substance use (TAPS1)
timeFrame: From Baseline to 24 weeks
measure: Gastrointestinal Constipation 9a
timeFrame: From Baseline to 24 weeks
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: University of Illinois at Chicago
name: Ardith Doorenbos, PhD, RN, FAAN
role: PRINCIPAL_INVESTIGATOR
References: