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临床试验/NCT04168437
NCT04168437已完成不适用

Optimizing Chronic Pain Management Through Patient Engagement With Quality of Life Measures: A Randomized Controlled Trial

University of North Texas Health Science Center2 个研究点 分布在 1 个国家目标入组 331 人开始时间: 2019年11月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
331
试验地点
2
主要终点
PROMIS-29 Quality of Life Measures

研究概览

简要总结

This study evaluates the use of a health-related quality of life report based on the SPADE cluster (sleep disturbance, pain interference with activities, anxiety, depression, and low energy/fatigue) derived from the PROMIS-29 instrument in patients with chronic low back pain. Half of the participants will receive the report, while the other half will not.

详细描述

The health-related quality of life report provides participants with an overall score on the SPADE cluster and scores on each of its five component scales. The recently released Federal Pain Research Strategy states that pain cannot be measured in isolation, but rather should be assessed in conjunction with other outcome measures in 'non-pain domains,' such as quality of life. It recognizes that pain may be affected by, and affect, such patient attributes as sleep, mood, cognition, function, and quality of life. Further, the report states that improvement in pain without concomitant improvement in other domains may not constitute a clinically meaningful outcome. This study primarily aims to assess the utility of a health-related quality of life report in improving quality of life, back pain intensity, and back-related disability in participants with chronic low back pain. Another aspect of the study will be to determine how the health-related quality of life report may impact the physician-patient interaction. This will be assessed using validated measures of physician interpersonal manner, empathy, and communication style, as well as end-of-trial survey data acquired from participants assigned to the experimental group. The survey will include an overall assessment of the report, as well as specific actions attributed to the report.

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
21 Years 至 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Chronic Low Back Pain AND SPADE Cluster Score ≥ 55

排除标准

  • Absence of Chronic Low Back Pain OR SPADE Cluster Score < 55

结局指标

主要结局

PROMIS-29 Quality of Life Measures

时间窗: 3 Months Post-Randomization

SPADE Cluster Scores (population mean, 50)

次要结局

  • Low Back Pain Intensity(3 Months Post-Randomization)
  • Back-Related Disability(3 Months Post-Randomization)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

John C. Licciardone, D.O., M.S., M.B.A.

Principal Investigator

University of North Texas Health Science Center

研究点 (2)

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