Hybrid Effectiveness-Implementation Trial of Guided Relaxation and Acupuncture for Chronic Sickle Cell Disease Pain
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 379
- 试验地点
- 5
- 主要终点
- PROMIS Pain Interference
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Control arm
Participants randomized to the control arm will receive usual care
Acupuncture
Acupuncture treatments twice a week for five weeks
干预措施: Acupuncture (Other)
Guided Relaxation
Daily use of a guided relaxation app for 6 weeks
干预措施: Guided Relaxation (Behavioral)
结局指标
主要结局
PROMIS Pain Interference
时间窗: 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)
时间窗: From Baseline to 24 weeks
0-10 rating on pain intensity, enjoyment of life and general activity
PROMIS Physical Function
时间窗: 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
次要结局
- PROMIS sleep disturbance 8a(From Baseline to 24 weeks)
- Patient's Global Impression of Change (PGIC)(From Baseline to 24 weeks)
- Generalised Anxiety Disorder Questionnaire (GAD-7)(From Baseline to 24 weeks)
- Patient Health Questionnaire Depression Scale (PHQ)(From Baseline to 24 weeks)
- Tobacco, Alcohol, Prescription medication, and other Substance use (TAPS1)(From Baseline to 24 weeks)
- Sleep duration(From Baseline to 24 weeks)
- Pain Catastrophizing Scale (PCS)(From Baseline to 24 weeks)
- Gastrointestinal Constipation 9a(From Baseline to 24 weeks)
研究者
Ardith Doorenbos
Professor in the Department of Biobehavioral Health Science, College of Nursing
University of Illinois at Chicago