Partners for Pain & Wellbeing Equity: A Randomized Trial of Community Supported Complementary and Integrative Health Self-management for Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Recruitment Feasibility: # of Enrolled Participants
研究概览
简要总结
The focus of this project is on developing and optimizing community-based programs for the self-management of back or neck pain for individuals from populations that experience health disparities (BP-PEHD). Community-engaged research approach will be used to conduct quality improvement activities that involves gathering feedback from multiple stakeholders to inform development of the study interventions and materials which will be followed by a randomized pilot study to evaluate feasibility.
Supported by the National Center for Complementary and Integrative Health through the National Institutes of Health's HEAL initiative (https://heal.nih.gov/)"
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provide a signed and dated informed consent form
- •State willingness to comply with all study procedures outlined in the consent form
- •Be 18 years of age or older
- •Have self-reported chronic back pain (defined as pain in the low or mid back, or neck pain) which has lasted for 3 months or longer
- •Have a score of 3 or higher on the self-reported Pain, Enjoyment of Life and General Activity (PEG) scale (0 to 10)
- •Be a member of one or more of the following NIH-designated health disparity populations: American Indian/Alaska Native, Asian, Black/African American, Hispanic/Latino, Native Hawaiian/Pacific Islanders, Socioeconomically disadvantaged (annual household income less than $50,000)
排除标准
- •Hospitalization for severe mental illness in past six months because the mindfulness and behavioral mind-body practices (e.g., meditation, progressive muscle relaxation, etc.) in the experimental intervention may aggravate symptoms of severe mental illness
- •Active psychotic symptoms, suicidal ideation, or manic episodes in the past three months for the same reasons noted in #1
- •Self-reported cancer with active treatment involving radiation or chemotherapy due to the potential for complications of their back or neck pain and impact on health outcomes
- •Dementia - Mini Mental State Exam score of 23 or lower for those with suspicion of cognitive impairment due to safety risks (e.g., not being able to follow directions for safe physical exercise)
- •Self-reported pregnancy due to the fact that back pain is often associated with pregnancy and differs from non-pregnancy related back pain and thus might have different impacts on health outcomes
- •Children under the age of 18
结局指标
主要结局
Recruitment Feasibility: # of Enrolled Participants
时间窗: 2 months
Demonstrate the ability to recruit and retain subjects in the clinical study as follows: Randomize at least 30 participants
Recruitment Feasibility: % of Enrolled Participants From NIH-defined Racial or Ethnic Disparity Groups
时间窗: 2 months
Demonstrate the ability to recruit and retain subjects in the clinical study as follows: 75% or more of randomized participants are from NIH-defined racial/ethnic health disparity groups;
Participant Retention Feasibility: Primary Outcome Measurement
时间窗: 2 months
Demonstrate the ability to recruit and retain subjects in the clinical study as follows: 80% or more of randomized participants are retained for primary outcome measurement at the end of the study (2 month follow up) regardless of adherence to the intervention
Intervention Delivery Feasibility: Participant Engagement
时间窗: 9 weeks
Demonstrate that the delivery of the intervention(s) and the control intervention(s) under study can be delivered consistently, as defined by: 85% or more of randomized participants engage in 1 or more sessions; 75% or more of randomized participants engage in at least 6 of 9 sessions
Intervention Fidelity: Facilitator Delivery of Required Activities
时间窗: 9 weeks
Demonstrate the fidelity of the intervention(s) used in the study by: Program facilitators deliver 90% of session activities during at least 90% of sessions
Data Collection Feasibility: Completion of Self-reported Outcomes
时间窗: 2 months
Demonstrate the ability to collect study data by: 80% or more of randomized participants complete follow up at 2 months (end of the study)
Safety and Tolerability of the Interventions: Severe or Serious Related Adverse Events
时间窗: 9 weeks
Demonstrate the safety and tolerability of the intervention(s) used in the study by: 5% or less of randomized participants experience a severe or serious adverse event related to the interventions
Safety and Tolerability of the Interventions: Satisfaction With Program
时间窗: 9 weeks
Demonstrate the safety and tolerability of the intervention(s) used in the study by: 75% or more of randomized participants are satisfied with assigned program
次要结局
未报告次要终点