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

December 24, 2015 updated by: David Coultas, The University of Texas Health Science Center at Tyler
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

325

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Tyler, Texas, United States, 75708
        • University of Texas Health Science Center-Tyler

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: COPD education + Usual care
Six weeks of COPD self-management education plus usual care
Other: COPD education + Usual care
Six weeks of COPD self-management education plus usual care
Experimental: Physical activity self-management
Cognitive behavioral counseling to increase lifestyle physical activity delivered over five months plus six weeks of COPD self-management education and usual care
Behavioral: Physical activity self-management
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chronic Respiratory Disease Questionnaire
Time Frame: 6, 12, and 18 months
Standardized quality-of-life instrument for patients with COPD.
6, 12, and 18 months
6-minute walk
Time Frame: 6, 12, and 18 months
Standardized walking test to measure functional capacity.
6, 12, and 18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost-effectiveness
Time Frame: 18 months
Health care utilization and SF-12 will be used to estimated cost effectiveness of the intervention.
18 months
Self-reported adverse event reporting
Time Frame: monthly for 18 months
Patients will be asked monthly about adverse events associated with study participation.
monthly for 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center at Tyler

Collaborators

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

Investigators

  • Principal Investigator: David B Coultas, MD, VA Portland Health Care System, Oregon Health & Science University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

April 21, 2010

First Submitted That Met QC Criteria

April 21, 2010

First Posted (Estimate)

April 22, 2010

Study Record Updates

Last Update Posted (Estimate)

December 29, 2015

Last Update Submitted That Met QC Criteria

December 24, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 679
  • R18HL092955-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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