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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
University of Texas
University of Alabama at Birmingham
Information provided by (Responsible Party):
David Coultas, The University of Texas Health Science Center at Tyler
ClinicalTrials.gov Identifier:
NCT01108991
First received: April 21, 2010
Last updated: December 2, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Chronic Obstructive Pulmonary Disease
Behavioral: Physical activity self-management
Other: COPD education + Usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Randomized Trial of Physical Activity Self-Management Intervention for Patients With COPD

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center at Tyler:

Primary Outcome Measures:
  • Chronic Respiratory Disease Questionnaire [ Time Frame: 6, 12, and 18 months ] [ Designated as safety issue: No ]
    Standardized quality-of-life instrument for patients with COPD.

  • 6-minute walk [ Time Frame: 6, 12, and 18 months ] [ Designated as safety issue: No ]
    Standardized walking test to measure functional capacity.


Secondary Outcome Measures:
  • Cost-effectiveness [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    Health care utilization and SF-12 will be used to estimated cost effectiveness of the intervention.

  • Self-reported adverse event reporting [ Time Frame: monthly for 18 months ] [ Designated as safety issue: Yes ]
    Patients will be asked monthly about adverse events associated with study participation.


Enrollment: 325
Study Start Date: April 2010
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01108991

Locations
United States, Texas
University of Texas Health Science Center-Tyler
Tyler, Texas, United States, 75708
Sponsors and Collaborators
The University of Texas Health Science Center at Tyler
University of Texas
University of Alabama at Birmingham
Investigators
Principal Investigator: David B Coultas, MD University of Texas Health Science Center-Tyler
  More Information

Publications:
Responsible Party: David Coultas, Vice President for Clinical and Academic Affairs, The University of Texas Health Science Center at Tyler
ClinicalTrials.gov Identifier: NCT01108991     History of Changes
Other Study ID Numbers: 679, R18HL092955-01A1
Study First Received: April 21, 2010
Last Updated: December 2, 2013
Health Authority: United States: Federal Government

Keywords provided by The University of Texas Health Science Center at Tyler:
Chronic obstructive pulmonary disease
Randomized controlled trial
Self-management support
Physical activity

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 16, 2014