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

Chronic Obstructive Pulmonary Disease Clinical Trial

— COPD-SMART  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01108991
• Other study ID #: 679
• Secondary ID: R18HL092955-01A1
• Status: Completed
• Phase: N/A
• First received: April 21, 2010
• Last updated: December 24, 2015
• Start date: April 2010
• Est. completion date: April 2014

Study information

• Verified date: December 2015
• Source: The University of Texas Health Science Center at Tyler
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 325
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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.

Other:
• COPD education + Usual care
Six weeks of COPD self-management education plus usual care

Locations

Country	Name	City	State
United States	University of Texas Health Science Center-Tyler	Tyler	Texas

Sponsors (4)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at Tyler	National Heart, Lung, and Blood Institute (NHLBI), University of Alabama at Birmingham, University of Texas

Country where clinical trial is conducted

United States, 

References & Publications (5)

Ashmore J, Russo R, Peoples J, Sloan J, Jackson BE, Bae S, Singh KP, Blair SN, Coultas D. Chronic obstructive pulmonary disease self-management activation research trial (COPD-SMART): design and methods. Contemp Clin Trials. 2013 Jul;35(2):77-86. doi: 10.1016/j.cct.2013.05.004. Epub 2013 May 13. — View Citation

Jackson BE, Coultas DB, Ashmore J, Russo R, Peoples J, Uhm M, Singh KP, Bae S. Domain-specific self-efficacy is associated with measures of functional capacity and quality of life among patients with moderate to severe chronic obstructive pulmonary diseas — View Citation

Jackson BE, Coultas DB, Suzuki S, Singh KP, Bae S. Rural-urban disparities in quality of life among patients with COPD. J Rural Health. 2013 Aug;29 Suppl 1:s62-9. doi: 10.1111/jrh.12005. Epub 2013 Feb 22. — View Citation

Russo R, Coultas D, Ashmore J, Peoples J, Sloan J, Jackson BE, Uhm M, Singh KP, Blair SN, Bae S. Chronic obstructive pulmonary disease self-management activation research trial (COPD-SMART): results of recruitment and baseline patient characteristics. Con — View Citation

Wortz K, Cade A, Menard JR, Lurie S, Lykens K, Bae S, Jackson B, Su F, Singh K, Coultas D. A qualitative study of patients' goals and expectations for self-management of COPD. Prim Care Respir J. 2012 Dec;21(4):384-91. doi: 10.4104/pcrj.2012.00070. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chronic Respiratory Disease Questionnaire	Standardized quality-of-life instrument for patients with COPD.	6, 12, and 18 months	No
Primary	6-minute walk	Standardized walking test to measure functional capacity.	6, 12, and 18 months	No
Secondary	Cost-effectiveness	Health care utilization and SF-12 will be used to estimated cost effectiveness of the intervention.	18 months	No
Secondary	Self-reported adverse event reporting	Patients will be asked monthly about adverse events associated with study participation.	monthly for 18 months	Yes