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Completed

NCT Number: NCT01108991

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

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.

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Key information

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Texas Health Science Center-Tyler

Tyler, Texas, 75708, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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%

Exclusion criteria

  • 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

Treatment and study plan

Physical activity self-management

Behavioral

This intervention includes a manual, telephone health coach calls, and automated telephone calls. The manual has 20 chapters for the active phase and 5 maintenance phase chapters. During the first 20 weeks the health coach will call patients every other week and the automated telephone calls will occur on the alternate weeks.

COPD education + Usual care

Other

Six weeks of COPD self-management education plus usual care

Primary outcomes

  1. Chronic Respiratory Disease Questionnaire

    Time frame: 6, 12, and 18 months

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

  2. 6-minute walk

    Time frame: 6, 12, and 18 months

    Standardized walking test to measure functional capacity.

Secondary outcomes

  1. Cost-effectiveness

    Time frame: 18 months

    Health care utilization and SF-12 will be used to estimated cost effectiveness of the intervention.

  2. Self-reported adverse event reporting

    Time frame: monthly for 18 months

    Patients will be asked monthly about adverse events associated with study participation.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at Tyler

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)
  • University of Alabama at Birmingham
  • University of Texas

Registry information

Acronym: COPD-SMART

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Apr 22, 2010
Registry last updated
Dec 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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