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

NCT01108991 | Completed DMC

• 2 other identifiers: 679R18HL092955-01A1
• Study Type: interventional
• Target: 325
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Chronic Respiratory Disease Questionnaire

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

  6, 12, and 18 months

• 6-minute walk

  Standardized walking test to measure functional capacity.

  6, 12, and 18 months

Secondary Outcomes (2)

• Cost-effectiveness

  18 months

• Self-reported adverse event reporting

  monthly for 18 months

Study Arms (2)

COPD education + Usual care

ACTIVE COMPARATOR

Six weeks of COPD self-management education plus usual care

Other: COPD education + Usual care

Physical activity self-management

EXPERIMENTAL

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

Interventions

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.

Physical activity self-management

COPD education + Usual care OTHER

Six weeks of COPD self-management education plus usual care

COPD education + Usual care

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center at Tyler: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• University of Texas: collaborator
• University of Alabama at Birmingham: collaborator

Study Sites (1)

University of Texas Health Science Center-Tyler

Tyler, Texas, 75708, United States

Location

Related Publications (7)

• 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.

  PMID: 23680985 BACKGROUND

• 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.

  PMID: 23944281 RESULT

• 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.

  PMID: 23138844 RESULT

• 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.

  PMID: 25657053 RESULT

• 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.

  PMID: 24447029 RESULT

• 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.

  PMID: 29283670 DERIVED

• 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.

  PMID: 26785249 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Motor Activity

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• David B Coultas, MD

  VA Portland Health Care System, Oregon Health & Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President for Clinical and Academic Affairs

Study Record Dates

• First Submitted: April 21, 2010
• First Posted: April 22, 2010
• Study Start: April 1, 2010
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: December 29, 2015

Record last verified: 2015-12

Locations

US (1)