Chronic Obstructive Pulmonary DiseaseCOPD-SMARTNCT01108991
Randomized Trial of Physical Activity Self-Management Intervention for Patients With COPD
A study testing Physical activity self-management in people with Chronic Obstructive Pulmonary Disease, run by The University of Texas Health Science Center at Tyler at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Physical activity self-management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 325 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2010to Apr 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Health Science Center-Tyler
Tyler, Texas, 75708
About this study
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.
Read the 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
- Being tested
- Physical activity self-management, COPD education + Usual care
- Keywords
- Chronic obstructive pulmonary disease, Randomized controlled trial, Self-management support, Physical activity
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity self-managementBehavioural
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.
COPD education + Usual careOther
Six weeks of COPD self-management education plus usual care
| Study group | Role | What they receive |
|---|---|---|
| COPD education + Usual care | Active comparator | Six weeks of COPD self-management education plus usual care Receives: 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 Receives: Behavioral: Physical activity self-management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic Respiratory Disease Questionnaire
Standardized quality-of-life instrument for patients with COPD.
Measured: 6, 12, and 18 months
6-minute walk
Standardized walking test to measure functional capacity.
Measured: 6, 12, and 18 months
Secondary outcomes (2)
Cost-effectiveness
Health care utilization and SF-12 will be used to estimated cost effectiveness of the intervention.
Measured: 18 months
Self-reported adverse event reporting
Patients will be asked monthly about adverse events associated with study participation.
Measured: monthly for 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 325 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center at Tyler
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), University of Texas, University of Alabama at Birmingham
- Responsible party
- Principal investigator, David Coultas, The University of Texas Health Science Center at Tyler
- Investigators
- David B Coultas, MD, Principal investigator, VA Portland Health Care System, Oregon Health & Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01108991
- Sponsor's protocol ID
- 679
- Other IDs
- R18HL092955-01A1
- Acronym
- COPD-SMART
- Status last verified
- Dec 2015
- First submitted
- 21 Apr 2010
- Last updated
- 29 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23680985Jackson 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.
PubMed 23944281Wortz 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.
PubMed 23138844Russo 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.
PubMed 25657053Jackson 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.
PubMed 24447029Coultas 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.
PubMed 29283670Coultas 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.
PubMed 26785249
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Physical Activity Self-Management Intervention for Patients With COPD
- ClinicalTrials.gov ID
- NCT01108991
- Acronym / sponsor ID
- COPD-SMART / 679
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Chronic obstructive pulmonary disease, Randomized controlled trial, Self-management support, Physical activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 325 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at TylerUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), University of Texas, University of Alabama at Birmingham
- Study start
- Apr 2010
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 22 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| COPD education + Usual care | Active comparator | Other: COPD education + Usual careSix weeks of COPD self-management education plus usual care |
| Physical activity self-management | Experimental | Behavioral: Physical activity self-managementCognitive behavioral counseling to increase lifestyle physical activity delivered over five months plus six weeks of COPD self-management education and usual care |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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%
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activity self-managementThis 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. | Behavioural | Physical activity self-management |
| COPD education + Usual careSix weeks of COPD self-management education plus usual care | Other | COPD education + Usual care |
Primary outcome
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.
2 secondary outcomes
Cost-effectiveness
Time frame: 18 months
Self-reported adverse event reporting
Time frame: monthly for 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2015.
- Background: PubMed 23680985Ashmore 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.
- Results publication: PubMed 23944281Jackson 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.
- Results publication: PubMed 23138844Wortz 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.
- Results publication: PubMed 25657053Russo 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.
- Results publication: PubMed 24447029Jackson 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.
- Derived from this study: PubMed 29283670Coultas 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.
- Derived from this study: PubMed 26785249Coultas 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David B Coultas, MD principal investigator
VA Portland Health Care System, Oregon Health & Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity self-management in people with Chronic Obstructive Pulmonary Disease, run by The University of Texas Health Science Center at Tyler at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chronic Respiratory Disease Questionnaire (time frame: 6, 12, and 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01108991, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2015.