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临床试验/NCT01108991
NCT01108991已完成不适用

Randomized Trial of Physical Activity Self-Management Intervention for Patients With COPD

The University of Texas Health Science Center at Tyler1 个研究点 分布在 1 个国家目标入组 325 人开始时间: 2010年4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
入组人数
325
试验地点
1
主要终点
6-minute walk

研究概览

简要总结

Chronic obstructive pulmonary disease (COPD) is a common condition associated with major disability. There is strong evidence that pulmonary rehabilitation (PR) improves outcomes and is cost saving, but fewer than 2% of patients have access to these programs. New methods of PR are needed to increase access of patients with COPD to these established benefits. To address this gap we propose a novel physical activity self-management (PASM) program based on an evidence-based physical activity intervention designed to increase physical activity and quality of life. Key components of the program include tailored telephone counseling, a workbook, and computer-assisted telephone follow-up. We will test the following two hypotheses: 1) Patients with COPD who receive PASM have clinically and statistically significant improvements in functional performance (i.e., Chronic Respiratory Questionnaire [CRQ] dyspnea domain and 6-minute walk) compared to patients who receive UC. 2) The PASM program is more cost-effective compared to the UC. The project addresses a major gap in the current management of COPD and may provide a novel, cost-effective strategy for improving functional performance and health status.

详细描述

Chronic obstructive pulmonary disease (COPD) has been targeted nationally as a "priority" condition for which multiple strategies are needed to improve outcomes. The absolute number of years lost to disability due to COPD exceeds the years of life lost due to premature death. There is strong evidence that pulmonary rehabilitation (PR) improves outcomes and is cost saving, but fewer than 2% of patients have access to these programs. New methods of PR are needed to increase access of patients with COPD to these established benefits. To address this gap we propose a novel physical activity self-management (PASM) program based on an evidence-based physical activity intervention designed to increase physical activity and quality of life. Key components of the program include tailored telephone counseling, a workbook, and computer-assisted telephone follow-up. Our specific aims are: 1) To implement a PASM program for patients with COPD. 2) To conduct an 18-month, randomized, controlled, single-blind trial comparing PASM (n=150) to usual care (UC) (n=150) to determine the effectiveness on functional performance and health status. 3) To determine the cost-effectiveness of the intervention. Follow-up data will be collected at 6, 12, and 18 months after start of the intervention. We will test the following two hypotheses: 1) Patients with COPD who receive PASM have clinically and statistically significant improvements in functional performance (i.e., Chronic Respiratory Questionnaire [CRQ] dyspnea domain and 6-minute walk) compared to patients who receive UC. 2) The PASM program is more cost-effective compared to the UC. The project addresses a major gap in the current management of COPD and may provide a novel, cost-effective strategy for improving functional performance and health status.

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
Single (Outcomes Assessor)

入排标准

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

入选标准

  • •A physician diagnosis of COPD
  • •Age 45 years and older
  • •Affirmative response to "Are you short of breath when hurrying on the level or walking up a slight hill?"
  • •Post-bronchodilator FEV1/FVC <0.7 and FEV1 <70%

排除标准

  • •Inability to speak/read English
  • •Lives in a chronic care facility (i.e., nursing home, assisted living)
  • •Plans to move from the area within the next 18 months
  • •Life expectancy less than 12 months
  • •Participation in pulmonary rehabilitation or other clinical research in the past 12 months
  • •Inability to walk without assistance of a wheelchair or walker
  • •Inability to walk at least 110m on a 6-minute walk
  • •Uncontrolled angina, hypertension, psychiatric illness, or dementia
  • •Inability to obtain supplemental oxygen if indicated

研究组 & 干预措施

COPD education + Usual care

Active Comparator

Six weeks of COPD self-management education plus usual care

干预措施: COPD education + Usual care (Other)

Physical activity self-management

Experimental

Cognitive behavioral counseling to increase lifestyle physical activity delivered over five months plus six weeks of COPD self-management education and usual care

干预措施: Physical activity self-management (Behavioral)

结局指标

主要结局

6-minute walk

时间窗: 6, 12, and 18 months

Standardized walking test to measure functional capacity.

Chronic Respiratory Disease Questionnaire

时间窗: 6, 12, and 18 months

Standardized quality-of-life instrument for patients with COPD.

次要结局

  • Cost-effectiveness(18 months)
  • Self-reported adverse event reporting(monthly for 18 months)

研究者

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

David Coultas

Vice President for Clinical and Academic Affairs

The University of Texas Health Science Center at Tyler

研究点 (1)

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