Evaluation of a Peer Coach-Led Intervention to Improve Pain Symptoms (ECLIPSE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 215
- 试验地点
- 2
- 主要终点
- Brief Pain Inventory (BPI) (Overall Pain Assessment)
研究概览
简要总结
To maximize implementation potential of pain self-management in the VA, alternative delivery methods are needed to provide Veterans with education and support needed to self-manage their pain, without requiring additional resources from healthcare teams. A novel and promising approach is a peer coaching model, in which Veterans with chronic pain who are successfully managing their pain offer information, support, and mentorship to other Veterans with pain.
详细描述
The investigators' goal is to test the effectiveness of a peer coaching model among Veterans. The investigators are examining feasibility for implementation alongside effectiveness, to shorten the timeline to implementation.
Aim 1 (primary aim): To compare 6-month (primary endpoint) and 9-month (sustained effects) effects of peer-supported chronic pain self-management versus controls on overall pain (intensity and function).
Hypothesis 1: Veterans in the peer support arm will experience reduced overall pain compared to controls.
Aim 2 (secondary aim): To compare 6- and 9-month effects of peer-supported chronic pain self-management versus controls on self-efficacy, social support, pain coping, patient activation, health-related quality of life, and health service utilization.
Hypothesis 2: Veterans in the peer support arm will experience greater self-efficacy, social support, pain coping, patient activation, and health-related quality of life, and lower health service utilization, compared to controls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- •have musculoskeletal pain in the low back, cervical spine, or extremities (hip, knee, or shoulder) for 3 months
- •have at least moderate pain severity, defined by pain 5 on a 0 (no pain) to 10 (worst pain imaginable) scale
- •indicate willingness to engage in phone or in-person contact on a regular basis with another Veteran
排除标准
- •if the electronic medical record indicates a diagnosis of a psychotic disorder (e.g., International Classification of Diseases (ICD) ICD-9 codes 295-295.9 for schizophrenia)
- •current substance dependence (e.g., ICD-9 codes 304-304.9)
- •severe medical conditions precluding participation (e.g., New York Heart Association Class III or IV heart failure, ICD-9 codes 428-428.9 )
- •if the eligibility screener given to prospective participants reveals active suicidal ideation severe hearing or speech impairment
- •pending surgery for a musculoskeletal condition (e.g., back surgery)
结局指标
主要结局
Brief Pain Inventory (BPI) (Overall Pain Assessment)
时间窗: 9 months
The BPI was developed to assess the severity of pain and the impact of pain on daily functioning, and has been validated in primary care studies. (Range = 0-10, 0 = no pain, 10 = worst pain imaginable)
次要结局
- Anxiety(9 months)
- Patient Activation(9 months)
- Perceived Social Support(9 months)
- Self Efficacy(9 months)
- Depression(9 months)
- General Health Perceptions(9 months)
- Pain Catastrophizing(9 months)