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

NCT ID: NCT01108991

Last Updated: 2015-12-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 325 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2014-04-30

Brief 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.

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic obstructive pulmonary disease; Randomized controlled trial; Self-management support; Physical activity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

COPD education + Usual care

Six weeks of COPD self-management education plus usual care

Group Type: ACTIVE_COMPARATOR

COPD education + Usual care

Intervention Type: OTHER

Six weeks of COPD self-management education plus usual care

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

Group Type: EXPERIMENTAL

Physical activity self-management

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

COPD education + Usual care

Six weeks of COPD self-management education plus usual care

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of Texas

OTHER

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: collaborator

The University of Texas Health Science Center at Tyler

OTHER

Sponsor Role: lead

Responsible Party

David Coultas

Vice President for Clinical and Academic Affairs

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David B Coultas, MD

Role: PRINCIPAL_INVESTIGATOR

VA Portland Health Care System, Oregon Health & Science University

Locations

University of Texas Health Science Center-Tyler

Tyler, Texas, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 23680985 (View on PubMed)

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(0 1):s62-9. doi: 10.1111/jrh.12005. Epub 2013 Feb 22.

Reference Type: RESULT

PMID: 23944281 (View on PubMed)

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.

Reference Type: RESULT

PMID: 23138844 (View on PubMed)

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. Contemp Clin Trials. 2015 Mar;41:192-201. doi: 10.1016/j.cct.2015.01.018. Epub 2015 Feb 3.

Reference Type: RESULT

PMID: 25657053 (View on PubMed)

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 disease. Ann Am Thorac Soc. 2014 Mar;11(3):310-5. doi: 10.1513/AnnalsATS.201308-273BC.

Reference Type: RESULT

PMID: 24447029 (View on PubMed)

Coultas DB, Jackson BE, Russo R, Peoples J, Singh KP, Sloan J, Uhm M, Ashmore JA, Blair SN, Bae S. Home-based Physical Activity Coaching, Physical Activity, and Health Care Utilization in Chronic Obstructive Pulmonary Disease. Chronic Obstructive Pulmonary Disease Self-Management Activation Research Trial Secondary Outcomes. Ann Am Thorac Soc. 2018 Apr;15(4):470-478. doi: 10.1513/AnnalsATS.201704-308OC.

Reference Type: DERIVED

PMID: 29283670 (View on PubMed)

Coultas DB, Jackson BE, Russo R, Peoples J, Sloan J, Singh KP, Ashmore J, Blair SN, Uhm M, Bae S. A Lifestyle Physical Activity Intervention for Patients with Chronic Obstructive Pulmonary Disease. A Randomized Controlled Trial. Ann Am Thorac Soc. 2016 May;13(5):617-26. doi: 10.1513/AnnalsATS.201508-508OC.

Reference Type: DERIVED

PMID: 26785249 (View on PubMed)

Other Identifiers

R18HL092955-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

679

Identifier Type: -

Identifier Source: org_study_id