Cooperative Pain Education and Self-management: Expanding Treatment for Real-world Access (COPES ExTRA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 764
- 试验地点
- 9
- 主要终点
- Mean Brief Pain Inventory, Interference Subscale (BPI-I) Score
研究概览
简要总结
To conduct a superiority trial of COPES versus standard Veterans Health Administration (VHA) Cognitive Behavioral Therapy Chronic Pain (CBT-CP)
详细描述
Our prior efficacy trial found that COPES was not inferior to in-person CBT-CP and that participants attended, on average, a little over two more treatment weeks in COPES than in-person treatment, presumably due to the ease of in-home treatment attendance relative to in-person treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients with chronic musculoskeletal pain receiving care in VHA.
- •A pain-related musculoskeletal diagnosis indicated by an EHR identified ICD-9 or -10 code.
- •The presence of chronic pain of at least moderate severity with EHR NRS pain scores ≥ 4 in three separate months for a period of 12 months.
- •Absence of mental illness serious enough to have resulted in an inpatient psychiatric hospitalization in the prior 3 months excluding detoxification of alcohol or drugs.
- •Absence of malignant cancer diagnosis or receipt of hospice or end-of-life palliative care.
- •Ability to participate safely in the walking portion of the intervention as evidenced by patient-reported ability to walk at least one block and absence of diabetic foot ulcers at the time of the enrollment.
- •Absence of significant cognitive impairment as identified by a dementia-related diagnosis.
- •Availability of a touch-tone land-line or cellular telephone and no vision or hearing deficits that would impair participation verified by patient report at the time of the enrollment call.
排除标准
- •Patients not fitting criteria for inclusion.
研究组 & 干预措施
data from veterans using CBT-CP
Data from veterans using CBT-CP for chronic pain
干预措施: CBT-CP (Behavioral)
data from veterans using COPES
Data from veterans using COPES for chronic pain
干预措施: COPES (Behavioral)
结局指标
主要结局
Mean Brief Pain Inventory, Interference Subscale (BPI-I) Score
时间窗: 4 months
The BPI-I Score is patient-reported pain-related interference. BPI-I score range is 0 to 10. Higher scores indicate worse functioning.
次要结局
- Mean Brief Pain Inventory, Interference Subscale (BPI-I) Score(6 months)
- Mean Brief Pain Inventory, Interference Subscale (BPI-I) Score(12 months)
- Mean Pain, Enjoyment, General Activity Scale (PEG-3) Score(4 month)
- Mean Patient Health Questionnaire (PHQ-8) Score(4 months)
- Mean Pain Catastrophizing Scale (PCS)- Short Form(4 months)
- Mean Insomnia Severity Index (ISI) Score(4 months)
- Mean Pain Self-Efficacy Questionnaire (PSEQ) Score(4 months)
- Patient Global Perception of Change (PGIC)(4 months)
- Mean Pain Satisfaction Questionnaire Score(4 month)
- Difference in Treatment Dose(Up to 12 months post baseline)
- Mean Numeric Rating Score (NRS), Pain Intensity Score(4 months)