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临床试验/NCT02999685
NCT02999685已完成不适用

Home-based Health Management of COPD Patients

Mayo Clinic1 个研究点 分布在 1 个国家目标入组 154 人开始时间: 2016年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
Mayo Clinic
入组人数
154
试验地点
1
主要终点
Quality of Life: Chronic Respiratory Questionaire

研究概览

简要总结

Regular physical activity has been found to be important in maintaining health and well-being in people with COPD. The purpose of this study is to test new technology and health coaching aimed to help people with COPD become more physically active in their daily lives.

详细描述

This study consists of a home-based pulmonary rehabilitation system. The system consists of a tablet computer, pulse oximeter, activity monitor and weekly telephone health coach calls. The rehabilitation period lasts 8 weeks. This is a randomized trial with two groups. Group A will complete the study activities during the first 8 weeks of the study followed by a period of observation. Group B will complete 8 weeks of observation followed by 8 weeks of rehabilitation.

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
40 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •• Men and women age 40 years and older
  • •Current or former smoker of at least 10 pack-years
  • •Diagnosis of Global Initiative for Chronic Lung Disease (GOLD) stage II, III or IV COPD as documented by pulmonary function
  • •Are eligible for Pulmonary Rehabilitation

排除标准

  • •• Unable to perform mild exercises
  • •Patients with a high likelihood of being lost to follow-up or contact (patients with active chemical dependency), are planning to move out of the state, are not living in the healthcare area.
  • •Patients with an inability to provide good data or follow commands (patients who are disoriented, have a severe neurologic or psychiatric condition).

研究组 & 干预措施

Home-base Pulm Rehab w/ Health Coaching

Active Comparator

The intervention group starts with 8 weeks of Home-base Pulmonary Rehab with Health Coaching, followed by 8 weeks of observation.

干预措施: Home-base Pulmonary Rehab with Health Coaching (Behavioral)

Control/Wait

Active Comparator

The Control/Wait group starts with 8 weeks of observation, followed by 8 weeks of intervention (Home-base Pulm Rehab w/ Health Coaching).

干预措施: Home-base Pulmonary Rehab with Health Coaching (Behavioral)

结局指标

主要结局

Quality of Life: Chronic Respiratory Questionaire

时间窗: 8 weeks from the start of the intervention

To determine the effect of the proposed system on disease specific quality of life. The instrument has 2 summary scores, physical and emotional

Daily Physical Activity measured by Actigraph

时间窗: 8 weeks from the start of the intervention

To determine the effectiveness of the proposed system, on daily physical activity measured by triaxial accelerometers

次要结局

未报告次要终点

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Roberto P. Benzo

M.D.

Mayo Clinic

研究点 (1)

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