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临床试验/NCT01517256
NCT01517256已完成3 期

Living Everyday Above-and-beyond Pain Research (LEAP): A Pilot Study Evaluating a Multidisciplinary Chronic Pain Group Therapy in a Primary Care Setting

McMaster University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2009年11月1日最近更新:
适应症
干预措施

试验速览

阶段
3 期
状态
已完成
入组人数
60
试验地点
1
主要终点
Quality of Life

研究概览

简要总结

The investigators will evaluate the effectiveness of "Living Everyday Above-and-beyond Pain" (LEAP) program in the primary care setting. LEAP is a multidisciplinary chronic pain group therapy developed for the two clinic sites of McMaster Family Health Team: McMaster Family Practice and Stonechurch Family Health Centre. LEAP aims to improve patients'quality of life, interaction with the health care system and their health care utilization. This is a pilot study to evaluate mainly feasibility. The investigators will make use of both experimental and qualitative methods gather evidence of the programs success, strengths and weaknesses.

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
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

  • •18 years and older
  • •diagnosed with chronic pain

排除标准

  • •chronic pain related to cancer, pelvic pain or headache
  • •inability to speak or write in English
  • •patient is unable to attend and participate in group treatment sessions on their own
  • •substance use or mental health problems of a severity making group treatment participation impossible
  • •currently participating in another cognitive-behavioral pain management program
  • •patient is receiving palliative care or has been diagnosed with an illness expecting to cause death within one year

研究组 & 干预措施

Early Intervention Group

Experimental

干预措施: Living Everyday Above-and-beyond Pain (LEAP) (Behavioral)

Delayed Intervention Group

Placebo Comparator

Initially wait-listed and served as control group. But later participants underwent the experimental intervention.

干预措施: Wait-listed (Other)

结局指标

主要结局

Quality of Life

时间窗: 8 months

This will utilize the SF-36 QOL questionnaire.

Health care utilization

时间窗: 8 months

This will be based on a chart review to assess the number of consultations with their family physician and other clinicians (Nurse practitioners, registered nurse, dietitian, social worker).

次要结局

  • Qualitative process evaluation (Perceptions of participants regarding the intervention)(16 months)
  • Pain medication use(8 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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