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临床试验/NCT00736268
NCT00736268已完成不适用

Telephone-based Intervention for Patients With COPD and Their Caregivers

Duke University4 个研究点 分布在 1 个国家目标入组 746 人开始时间: 2008年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
746
试验地点
4
主要终点
Composite measure of psychological quality of life, composite index of all cause mortality and COPD-related hospitalization.

研究概览

简要总结

This study is an NIH-funded clinical trial conducted at Duke University Medical Center and Ohio State University. The purpose of this study is to examine the effects of a telephone-based, care-giver assisted, coping skills training (CST) program in patients with Chronic Obstructive Pulmonary Disease (COPD) and their caregivers. This may help COPD patients and their caregivers to deal better with the stress of lung disease. This study will test 3 primary hypotheses: 1) That enhanced CST will be more effective in improving quality of life compared to a Usual Medical Care plus COPD education and symptom management control group; 2) That enhanced CST will be associated with better medical outcomes (i.e., greater survival and fewer COPD-related physician visits or hospitalizations) compared to Controls over a follow-up period of up to 4 years; and 3) That improvements in quality of life and survival will be mediated by increased functional capacity and better coping.

This proposed study builds upon our prior research by: a) adapting and refining our CST protocol, which was effective in improving psychosocial adjustment in patients awaiting lung transplantation, to a broader population of patients with COPD who are not immediate candidates for lung transplantation; b) enhancing our intervention to improve functional capacity, reduce somatic symptoms, and improve survival; c) examining the impact of CST on medical expenditures; and d) including caregivers in an enhanced CST intervention.

详细描述

Overall, 746 participants (patients and caregivers) were consented for participation into this study from both Duke University Medical Center and Ohio State University. Of these, 326 patients were randomized and participated in the study intervention along with 252 consented participants who acted as a caregiver; in total 578 participants (patients and caregivers) were involved with the study intervention.

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
Single (Outcomes Assessor)

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • male or female outpatients 21 years of age or older
  • a diagnosis of COPD
  • FEV1 25%-80% of predicted value
  • FEV1/FVC <70%
  • capacity to give informed consent and follow study procedures

排除标准

  • psychotic features including delusions or hallucinations
  • acute suicide or homicide risk
  • other illness (e.g., cancer) that is likely to cause death within 3 years
  • unstable angina
  • congestive heart failure stage III - IV by NYHA classification
  • active involvement in pulmonary rehabilitation or a formal exercise program

结局指标

主要结局

Composite measure of psychological quality of life, composite index of all cause mortality and COPD-related hospitalization.

时间窗: 4 years

次要结局

  • Composite measure of somatic quality of life(4 months and up to 4 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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