Randomized Trial of Physical Activity Self-Management Intervention for Patients With COPD (COPD-SMART)
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01108991 |
|
Recruitment Status :
Completed
First Posted : April 22, 2010
Last Update Posted : December 29, 2015
|
Sponsor:
The University of Texas Health Science Center at Tyler
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
University of Texas
University of Alabama at Birmingham
Information provided by (Responsible Party):
David Coultas, The University of Texas Health Science Center at Tyler
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Chronic Obstructive Pulmonary Disease | Behavioral: Physical activity self-management Other: COPD education + Usual care | Not Applicable |
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 (Clinical Trial) |
| Actual Enrollment : | 325 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Supportive Care |
| Official Title: | Randomized Trial of Physical Activity Self-Management Intervention for Patients With COPD |
| Study Start Date : | April 2010 |
| Actual Primary Completion Date : | April 2014 |
| Actual Study Completion Date : | April 2014 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Health Checkup
| 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. |
Primary Outcome Measures :
- Chronic Respiratory Disease Questionnaire [ Time Frame: 6, 12, and 18 months ]Standardized quality-of-life instrument for patients with COPD.
- 6-minute walk [ Time Frame: 6, 12, and 18 months ]Standardized walking test to measure functional capacity.
Secondary Outcome Measures :
- Cost-effectiveness [ Time Frame: 18 months ]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 ]Patients will be asked monthly about adverse events associated with study participation.
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 45 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
National Heart, Lung, and Blood Institute (NHLBI)
University of Texas
University of Alabama at Birmingham
Investigators
| Principal Investigator: | David B Coultas, MD | VA Portland Health Care System, Oregon Health & Science University |
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | David Coultas, Vice President for Clinical and Academic Affairs, The University of Texas Health Science Center at Tyler |
| ClinicalTrials.gov Identifier: | NCT01108991 |
| Other Study ID Numbers: |
679 R18HL092955-01A1 ( U.S. NIH Grant/Contract ) |
| First Posted: | April 22, 2010 Key Record Dates |
| Last Update Posted: | December 29, 2015 |
| Last Verified: | December 2015 |
Keywords provided by David Coultas, 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 Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases |