User login
The clinical trials listed below are open as of February 21, 2025; have ≥ 1 US Department of Veterans Affairs (VA) medical center (VAMC) or US Department of Defense (DoD) military treatment facility location recruiting patients; and are focused on treatments for chronic obstructive pulmonary disease (COPD). For additional information and full inclusion/exclusion criteria, please consult clinicaltrials.gov.
Actively Recruiting
The Effect of Interval Exercise on Functional Outcomes in Veterans With COPD and OSA
The term overlap syndrome (OS) is used to describe the presence of both COPD and obstructive sleep apnea (OSA) in a single patient. Due to premature aging, patients with OS are prone to developing functional decline up to 20 years earlier than the general population. The International Classification of Functioning, Disability and Health (ICF) evaluates functional status in chronic pulmonary disease globally in 5 domains. The investigators propose to study validated outcomes in 3 of these domains: (1) participation in life situations; (2) physical activity; and (3) cardiovascular health. The investigators’ long-term goal is to develop an exercise strategy tailored to veterans with OS which will reduce the risk of functional decline through increased physical activity.
ID: NCT05254431
Sponsor; Collaborator: VA Office of Research and Development; Madalina Macrea, MD, PhD
Location: Salem VA Medical Center, Virginia
The Development of an Integrated Physical Activity and Mental Health Intervention for Veterans With COPD, Emotion Distress, and Low Physical Activity
COPD is a prevalent and debilitating chronic disease in veterans. COPD is highly comorbid with depression and anxiety, conferring greater morbidity and mortality risk. Physical activity is a modifiable behavior that can improve COPD outcomes. However, to date, interventions targeting physical activity have not addressed the high comorbidity between COPD and depression and/or anxiety symptoms (emotional distress) despite emotional distress predicting poorer response to physical activity interventions. This CDA-2 proposal will develop and test the acceptability and feasibility of an integrative physical activity and mental health intervention for veterans with COPD, emotional distress, and low physical activity. The intervention will be delivered via VA Video Connect enabling access to care among veterans with substantial barriers to hospital-based outpatient care.
ID: NCT04953806
Sponsor; Collaborator: VA Office of Research and Development; Patricia Bamonti, PhD
Location: VA Boston Healthcare System, Jamaica Plain Campus
Neurocognitive and Health Impact of Sleep Apnea in Elderly Veterans With Comorbid COPD
Cognitive dysfunction in the aging veteran population is a growing health concern in the Veterans Health System. It is not known whether OSA coexisting with COPD will enhance the risk for cognitive dysfunction. The investigators sought to investigate whether these two highly prevalent diseases that often coexist as 'overlap syndrome' combine to enhance cognitive impairment in the elderly veteran population. Thus, the investigators will study whether elderly patients with overlap syndrome have increased cognitive deficits compared with OSA or COPD alone. Additionally, treatment of OSA with positive airway pressure (PAP) has been shown to improve neurocognitive function in moderate-to-severe OSA while cognitive decline in COPD may be reversible through treatment with long-term oxygen therapy. The investigators will also study whether treatment with PAP and supplemental oxygen vs PAP alone will improve cognitive function and improve quality of life of elderly veterans.
ID: NCT02703207
Sponsor; Investigators: VA Office of Research and Development; Susmita Chowdhuri, MD, MS
Locations: John D. Dingell VA Medical Center, Detroit
The Effect of a Technology-Mediated Integrated Walking and Tai Chi Intervention on Physical Function in Veterans With COPD and Chronic Musculoskeletal Pain (WATCH for Pain)
Persons with COPD benefit from being physically active, but they are often limited by chronic musculoskeletal pain. This project will determine whether a non-pharmacologic, integrated, technology-mediated walking and tai chi mindfulness intervention can improve physical function in veterans with COPD and chronic musculoskeletal pain. The proposed research addresses VA Rehabilitation R&D Service's high priority area of improving health-related quality of life by reducing disease burden and maximizing function in veterans with chronic disease.
ID: NCT05701982
Sponsor; Investigator: VA Office of Research and Development; Marilyn L. Moy, MD; University of Michigan, Beth Israel Deaconess Medical Center
Location: VA Boston Healthcare System
Internet-based Cognitive-behavioral Treatment for Insomnia in COPD Patients Undergoing Pulmonary Rehabilitation
This study is a randomized controlled trial (RCT) to compare sleep and health-related functioning in veterans with COPD and insomnia receiving an Internet-based behavioral treatment for insomnia vs online insomnia patient education. Participants will undergo a sleep and health assessment that will be performed at baseline, post-treatment, and 3 months later. Participants will be randomly assigned to either Internet-based behavioral treatment for insomnia or online insomnia patient education.
ID: NCT04700098
Sponsor; Collaborators: VA Office of Research and Development; Faith S. Luyster, PhD
Locations: VA Pittsburgh Healthcare System; John D. Dingell VA Medical Center, Detroit
Breathe Easier With Tadalafil Therapy for Dyspnea in COPD-PH (BETTER COPD-PH)
The investigators will study whether the drug tadalafil improves shortness of breath in 126 veterans with COPD and high blood pressure in the lungs. The investigators will also assess whether tadalafil improves quality of life, home daily physical activity, exercise endurance, the frequency of acute flares of COPD, blood pressure in the lungs, and lung function. Veterans who enroll in the trial will be allocated by chance to either active tadalafil or an inactive identical capsule (placebo). Neither the veteran nor the investigator will know whether the veteran is taking tadalafil or placebo. Veterans will be followed closely in clinic or by telephone at 1, 2, 3, 4, 5, and 6 months, with attention to side effects and safety. At 1,3, and 6 months the investigators will repeat the questionnaires and testing of blood pressures in the lung and lung function. The investigators anticipate that the results of this study will determine whether tadalafil improves shortness of breath when added to usual medications for COPD.
ID: NCT05937854
Sponsor; Collaborator: VA Office of Research and Development; Sharon I. Rounds, MD
Locations: Rocky Mountain Regional VA Medical Center, Colorado; Joseph Maxwell Cleland Atlanta VA Medical Center ; VA Boston Healthcare System Jamaica Plain Campus; VA Nebraska-Western Iowa Health Care System; Providence VA Medical Center
Impact of Positive Airway Pressure Therapy on Clinical Outcomes in Older Veterans With Chronic Obstructive Pulmonary Disease and Comorbid Obstructive Sleep Apnea (Overlap Syndrome)
Obstructive sleep apnea (OSA) and COPD are highly prevalent chronic respiratory diseases in the veteran population. OSA co-occurring with COPD, known as overlap syndrome (OVS), is a complex chronic medical condition associated with grave consequences. OVS is highly prevalent in veterans. Veterans with OVS may be at increased risk for cognitive deficits, poor sleep quality as well as a reduced quality of life (QoL). The overall objective is to study the effects of positive airway pressure therapy on clinical outcomes in patients with OVS.
ID: NCT04179981
Sponsor; Investigator: VA Office of Research and Development; Susmita Chowdhuri, MD, MS
Locations: VA Ann Arbor Healthcare System; John D. Dingell VA Medical Center, Detroit
Developing an Intervention to Optimize Virtual Care Adoption for COPD Management (VC-OPTIONS)
VA is a leader in virtual care (VC), including the patient portal, mobile apps, and telehealth programs. VC has great utility for managing chronic conditions like COPD. However, adoption of many VC services has been slow. Lack of awareness about these services is one of the most prominent patient- and health care team-facing barriers to adopting VC. This study will develop, refine, and pilot a stakeholder-informed multicomponent implementation strategy to support adoption of VC, referred to as VC-OPTIONS (Virtual Care for Chronic Obstructive Pulmonary Disease Adoption Support). This feasibility trial will pilot the VC-OPTIONS implementation strategy to assess feasibility and acceptability and gather preliminary effectiveness data to inform a larger hybrid effectiveness-implementation trial. The core component of VC-OPTIONS will be the provision of information via VA's Annie texting program to empower patients with knowledge about the array of VC services and how they can be used to support COPD management. It is hypothesized that this strategy will be acceptable and feasible. This work will improve patient and team awareness of and communication about VC services, and support patient access to VC services for COPD management.
ID: NCT05986214
Sponsor; Collaborators: VA Office of Research and Development; Stephanie Robinson, PhD
Location: VA Bedford Healthcare System, Massachusetts; VA Boston Healthcare System Jamaica Plain Campus
Chronic Lung Disease and COVID-19: Understanding Severity, Recovery and Rehabilitation Needs (LAUREL)
This study is comprised of 3 approaches. First, the investigators will conduct a retrospective cohort study to determine factors associated with COVID-19 severity and complications and understand COVID-19 outcomes, including all-cause mortality, postdischarge events, and impacts of rehabilitation services (third aim). The second aim is a mixed-method study and follows COVID-19 patients with repeated surveys to determine patient-reported functional outcomes, health recovery, and rehabilitation needs after COVID-19. The investigators will recruit patients and their informal caregivers for interviews to assess their function and rehabilitation needs.
ID: NCT04628039
Sponsor; Collaborators: VA Office of Research and Development; Kristina A. Crothers, MD
Locations: VA Ann Arbor Healthcare System; VA Puget Sound Health Care System, Washington
Accessing Mobility Using Wearable Sensors
This study will examine whether wearable sensors can be used to track changes in cognitive-motor performance in response to a disease or an intervention. The investigators specific aims are twofold, first aim to explore whether and how a clinical condition such as chronic obstructive pulmonary disease (COPD) or congestive heart failure (CHF) may impact motor-cognitive performance measurable using validated wearable devices (eg, LEGSys, BalanSENS, and Frailty Meter). Second, the investigators will explore whether an exercise intervention provided via telemedicine (telerehabilitation) can enhance motor-cognitive performance.
ID: NCT04306588
Sponsor; Collaborators: Baylor College of Medicine, Bijan Najafi, PhD
Locations: Michael E. DeBakey Veterans Affairs Medical Center, Houston
The clinical trials listed below are open as of February 21, 2025; have ≥ 1 US Department of Veterans Affairs (VA) medical center (VAMC) or US Department of Defense (DoD) military treatment facility location recruiting patients; and are focused on treatments for chronic obstructive pulmonary disease (COPD). For additional information and full inclusion/exclusion criteria, please consult clinicaltrials.gov.
Actively Recruiting
The Effect of Interval Exercise on Functional Outcomes in Veterans With COPD and OSA
The term overlap syndrome (OS) is used to describe the presence of both COPD and obstructive sleep apnea (OSA) in a single patient. Due to premature aging, patients with OS are prone to developing functional decline up to 20 years earlier than the general population. The International Classification of Functioning, Disability and Health (ICF) evaluates functional status in chronic pulmonary disease globally in 5 domains. The investigators propose to study validated outcomes in 3 of these domains: (1) participation in life situations; (2) physical activity; and (3) cardiovascular health. The investigators’ long-term goal is to develop an exercise strategy tailored to veterans with OS which will reduce the risk of functional decline through increased physical activity.
ID: NCT05254431
Sponsor; Collaborator: VA Office of Research and Development; Madalina Macrea, MD, PhD
Location: Salem VA Medical Center, Virginia
The Development of an Integrated Physical Activity and Mental Health Intervention for Veterans With COPD, Emotion Distress, and Low Physical Activity
COPD is a prevalent and debilitating chronic disease in veterans. COPD is highly comorbid with depression and anxiety, conferring greater morbidity and mortality risk. Physical activity is a modifiable behavior that can improve COPD outcomes. However, to date, interventions targeting physical activity have not addressed the high comorbidity between COPD and depression and/or anxiety symptoms (emotional distress) despite emotional distress predicting poorer response to physical activity interventions. This CDA-2 proposal will develop and test the acceptability and feasibility of an integrative physical activity and mental health intervention for veterans with COPD, emotional distress, and low physical activity. The intervention will be delivered via VA Video Connect enabling access to care among veterans with substantial barriers to hospital-based outpatient care.
ID: NCT04953806
Sponsor; Collaborator: VA Office of Research and Development; Patricia Bamonti, PhD
Location: VA Boston Healthcare System, Jamaica Plain Campus
Neurocognitive and Health Impact of Sleep Apnea in Elderly Veterans With Comorbid COPD
Cognitive dysfunction in the aging veteran population is a growing health concern in the Veterans Health System. It is not known whether OSA coexisting with COPD will enhance the risk for cognitive dysfunction. The investigators sought to investigate whether these two highly prevalent diseases that often coexist as 'overlap syndrome' combine to enhance cognitive impairment in the elderly veteran population. Thus, the investigators will study whether elderly patients with overlap syndrome have increased cognitive deficits compared with OSA or COPD alone. Additionally, treatment of OSA with positive airway pressure (PAP) has been shown to improve neurocognitive function in moderate-to-severe OSA while cognitive decline in COPD may be reversible through treatment with long-term oxygen therapy. The investigators will also study whether treatment with PAP and supplemental oxygen vs PAP alone will improve cognitive function and improve quality of life of elderly veterans.
ID: NCT02703207
Sponsor; Investigators: VA Office of Research and Development; Susmita Chowdhuri, MD, MS
Locations: John D. Dingell VA Medical Center, Detroit
The Effect of a Technology-Mediated Integrated Walking and Tai Chi Intervention on Physical Function in Veterans With COPD and Chronic Musculoskeletal Pain (WATCH for Pain)
Persons with COPD benefit from being physically active, but they are often limited by chronic musculoskeletal pain. This project will determine whether a non-pharmacologic, integrated, technology-mediated walking and tai chi mindfulness intervention can improve physical function in veterans with COPD and chronic musculoskeletal pain. The proposed research addresses VA Rehabilitation R&D Service's high priority area of improving health-related quality of life by reducing disease burden and maximizing function in veterans with chronic disease.
ID: NCT05701982
Sponsor; Investigator: VA Office of Research and Development; Marilyn L. Moy, MD; University of Michigan, Beth Israel Deaconess Medical Center
Location: VA Boston Healthcare System
Internet-based Cognitive-behavioral Treatment for Insomnia in COPD Patients Undergoing Pulmonary Rehabilitation
This study is a randomized controlled trial (RCT) to compare sleep and health-related functioning in veterans with COPD and insomnia receiving an Internet-based behavioral treatment for insomnia vs online insomnia patient education. Participants will undergo a sleep and health assessment that will be performed at baseline, post-treatment, and 3 months later. Participants will be randomly assigned to either Internet-based behavioral treatment for insomnia or online insomnia patient education.
ID: NCT04700098
Sponsor; Collaborators: VA Office of Research and Development; Faith S. Luyster, PhD
Locations: VA Pittsburgh Healthcare System; John D. Dingell VA Medical Center, Detroit
Breathe Easier With Tadalafil Therapy for Dyspnea in COPD-PH (BETTER COPD-PH)
The investigators will study whether the drug tadalafil improves shortness of breath in 126 veterans with COPD and high blood pressure in the lungs. The investigators will also assess whether tadalafil improves quality of life, home daily physical activity, exercise endurance, the frequency of acute flares of COPD, blood pressure in the lungs, and lung function. Veterans who enroll in the trial will be allocated by chance to either active tadalafil or an inactive identical capsule (placebo). Neither the veteran nor the investigator will know whether the veteran is taking tadalafil or placebo. Veterans will be followed closely in clinic or by telephone at 1, 2, 3, 4, 5, and 6 months, with attention to side effects and safety. At 1,3, and 6 months the investigators will repeat the questionnaires and testing of blood pressures in the lung and lung function. The investigators anticipate that the results of this study will determine whether tadalafil improves shortness of breath when added to usual medications for COPD.
ID: NCT05937854
Sponsor; Collaborator: VA Office of Research and Development; Sharon I. Rounds, MD
Locations: Rocky Mountain Regional VA Medical Center, Colorado; Joseph Maxwell Cleland Atlanta VA Medical Center ; VA Boston Healthcare System Jamaica Plain Campus; VA Nebraska-Western Iowa Health Care System; Providence VA Medical Center
Impact of Positive Airway Pressure Therapy on Clinical Outcomes in Older Veterans With Chronic Obstructive Pulmonary Disease and Comorbid Obstructive Sleep Apnea (Overlap Syndrome)
Obstructive sleep apnea (OSA) and COPD are highly prevalent chronic respiratory diseases in the veteran population. OSA co-occurring with COPD, known as overlap syndrome (OVS), is a complex chronic medical condition associated with grave consequences. OVS is highly prevalent in veterans. Veterans with OVS may be at increased risk for cognitive deficits, poor sleep quality as well as a reduced quality of life (QoL). The overall objective is to study the effects of positive airway pressure therapy on clinical outcomes in patients with OVS.
ID: NCT04179981
Sponsor; Investigator: VA Office of Research and Development; Susmita Chowdhuri, MD, MS
Locations: VA Ann Arbor Healthcare System; John D. Dingell VA Medical Center, Detroit
Developing an Intervention to Optimize Virtual Care Adoption for COPD Management (VC-OPTIONS)
VA is a leader in virtual care (VC), including the patient portal, mobile apps, and telehealth programs. VC has great utility for managing chronic conditions like COPD. However, adoption of many VC services has been slow. Lack of awareness about these services is one of the most prominent patient- and health care team-facing barriers to adopting VC. This study will develop, refine, and pilot a stakeholder-informed multicomponent implementation strategy to support adoption of VC, referred to as VC-OPTIONS (Virtual Care for Chronic Obstructive Pulmonary Disease Adoption Support). This feasibility trial will pilot the VC-OPTIONS implementation strategy to assess feasibility and acceptability and gather preliminary effectiveness data to inform a larger hybrid effectiveness-implementation trial. The core component of VC-OPTIONS will be the provision of information via VA's Annie texting program to empower patients with knowledge about the array of VC services and how they can be used to support COPD management. It is hypothesized that this strategy will be acceptable and feasible. This work will improve patient and team awareness of and communication about VC services, and support patient access to VC services for COPD management.
ID: NCT05986214
Sponsor; Collaborators: VA Office of Research and Development; Stephanie Robinson, PhD
Location: VA Bedford Healthcare System, Massachusetts; VA Boston Healthcare System Jamaica Plain Campus
Chronic Lung Disease and COVID-19: Understanding Severity, Recovery and Rehabilitation Needs (LAUREL)
This study is comprised of 3 approaches. First, the investigators will conduct a retrospective cohort study to determine factors associated with COVID-19 severity and complications and understand COVID-19 outcomes, including all-cause mortality, postdischarge events, and impacts of rehabilitation services (third aim). The second aim is a mixed-method study and follows COVID-19 patients with repeated surveys to determine patient-reported functional outcomes, health recovery, and rehabilitation needs after COVID-19. The investigators will recruit patients and their informal caregivers for interviews to assess their function and rehabilitation needs.
ID: NCT04628039
Sponsor; Collaborators: VA Office of Research and Development; Kristina A. Crothers, MD
Locations: VA Ann Arbor Healthcare System; VA Puget Sound Health Care System, Washington
Accessing Mobility Using Wearable Sensors
This study will examine whether wearable sensors can be used to track changes in cognitive-motor performance in response to a disease or an intervention. The investigators specific aims are twofold, first aim to explore whether and how a clinical condition such as chronic obstructive pulmonary disease (COPD) or congestive heart failure (CHF) may impact motor-cognitive performance measurable using validated wearable devices (eg, LEGSys, BalanSENS, and Frailty Meter). Second, the investigators will explore whether an exercise intervention provided via telemedicine (telerehabilitation) can enhance motor-cognitive performance.
ID: NCT04306588
Sponsor; Collaborators: Baylor College of Medicine, Bijan Najafi, PhD
Locations: Michael E. DeBakey Veterans Affairs Medical Center, Houston
The clinical trials listed below are open as of February 21, 2025; have ≥ 1 US Department of Veterans Affairs (VA) medical center (VAMC) or US Department of Defense (DoD) military treatment facility location recruiting patients; and are focused on treatments for chronic obstructive pulmonary disease (COPD). For additional information and full inclusion/exclusion criteria, please consult clinicaltrials.gov.
Actively Recruiting
The Effect of Interval Exercise on Functional Outcomes in Veterans With COPD and OSA
The term overlap syndrome (OS) is used to describe the presence of both COPD and obstructive sleep apnea (OSA) in a single patient. Due to premature aging, patients with OS are prone to developing functional decline up to 20 years earlier than the general population. The International Classification of Functioning, Disability and Health (ICF) evaluates functional status in chronic pulmonary disease globally in 5 domains. The investigators propose to study validated outcomes in 3 of these domains: (1) participation in life situations; (2) physical activity; and (3) cardiovascular health. The investigators’ long-term goal is to develop an exercise strategy tailored to veterans with OS which will reduce the risk of functional decline through increased physical activity.
ID: NCT05254431
Sponsor; Collaborator: VA Office of Research and Development; Madalina Macrea, MD, PhD
Location: Salem VA Medical Center, Virginia
The Development of an Integrated Physical Activity and Mental Health Intervention for Veterans With COPD, Emotion Distress, and Low Physical Activity
COPD is a prevalent and debilitating chronic disease in veterans. COPD is highly comorbid with depression and anxiety, conferring greater morbidity and mortality risk. Physical activity is a modifiable behavior that can improve COPD outcomes. However, to date, interventions targeting physical activity have not addressed the high comorbidity between COPD and depression and/or anxiety symptoms (emotional distress) despite emotional distress predicting poorer response to physical activity interventions. This CDA-2 proposal will develop and test the acceptability and feasibility of an integrative physical activity and mental health intervention for veterans with COPD, emotional distress, and low physical activity. The intervention will be delivered via VA Video Connect enabling access to care among veterans with substantial barriers to hospital-based outpatient care.
ID: NCT04953806
Sponsor; Collaborator: VA Office of Research and Development; Patricia Bamonti, PhD
Location: VA Boston Healthcare System, Jamaica Plain Campus
Neurocognitive and Health Impact of Sleep Apnea in Elderly Veterans With Comorbid COPD
Cognitive dysfunction in the aging veteran population is a growing health concern in the Veterans Health System. It is not known whether OSA coexisting with COPD will enhance the risk for cognitive dysfunction. The investigators sought to investigate whether these two highly prevalent diseases that often coexist as 'overlap syndrome' combine to enhance cognitive impairment in the elderly veteran population. Thus, the investigators will study whether elderly patients with overlap syndrome have increased cognitive deficits compared with OSA or COPD alone. Additionally, treatment of OSA with positive airway pressure (PAP) has been shown to improve neurocognitive function in moderate-to-severe OSA while cognitive decline in COPD may be reversible through treatment with long-term oxygen therapy. The investigators will also study whether treatment with PAP and supplemental oxygen vs PAP alone will improve cognitive function and improve quality of life of elderly veterans.
ID: NCT02703207
Sponsor; Investigators: VA Office of Research and Development; Susmita Chowdhuri, MD, MS
Locations: John D. Dingell VA Medical Center, Detroit
The Effect of a Technology-Mediated Integrated Walking and Tai Chi Intervention on Physical Function in Veterans With COPD and Chronic Musculoskeletal Pain (WATCH for Pain)
Persons with COPD benefit from being physically active, but they are often limited by chronic musculoskeletal pain. This project will determine whether a non-pharmacologic, integrated, technology-mediated walking and tai chi mindfulness intervention can improve physical function in veterans with COPD and chronic musculoskeletal pain. The proposed research addresses VA Rehabilitation R&D Service's high priority area of improving health-related quality of life by reducing disease burden and maximizing function in veterans with chronic disease.
ID: NCT05701982
Sponsor; Investigator: VA Office of Research and Development; Marilyn L. Moy, MD; University of Michigan, Beth Israel Deaconess Medical Center
Location: VA Boston Healthcare System
Internet-based Cognitive-behavioral Treatment for Insomnia in COPD Patients Undergoing Pulmonary Rehabilitation
This study is a randomized controlled trial (RCT) to compare sleep and health-related functioning in veterans with COPD and insomnia receiving an Internet-based behavioral treatment for insomnia vs online insomnia patient education. Participants will undergo a sleep and health assessment that will be performed at baseline, post-treatment, and 3 months later. Participants will be randomly assigned to either Internet-based behavioral treatment for insomnia or online insomnia patient education.
ID: NCT04700098
Sponsor; Collaborators: VA Office of Research and Development; Faith S. Luyster, PhD
Locations: VA Pittsburgh Healthcare System; John D. Dingell VA Medical Center, Detroit
Breathe Easier With Tadalafil Therapy for Dyspnea in COPD-PH (BETTER COPD-PH)
The investigators will study whether the drug tadalafil improves shortness of breath in 126 veterans with COPD and high blood pressure in the lungs. The investigators will also assess whether tadalafil improves quality of life, home daily physical activity, exercise endurance, the frequency of acute flares of COPD, blood pressure in the lungs, and lung function. Veterans who enroll in the trial will be allocated by chance to either active tadalafil or an inactive identical capsule (placebo). Neither the veteran nor the investigator will know whether the veteran is taking tadalafil or placebo. Veterans will be followed closely in clinic or by telephone at 1, 2, 3, 4, 5, and 6 months, with attention to side effects and safety. At 1,3, and 6 months the investigators will repeat the questionnaires and testing of blood pressures in the lung and lung function. The investigators anticipate that the results of this study will determine whether tadalafil improves shortness of breath when added to usual medications for COPD.
ID: NCT05937854
Sponsor; Collaborator: VA Office of Research and Development; Sharon I. Rounds, MD
Locations: Rocky Mountain Regional VA Medical Center, Colorado; Joseph Maxwell Cleland Atlanta VA Medical Center ; VA Boston Healthcare System Jamaica Plain Campus; VA Nebraska-Western Iowa Health Care System; Providence VA Medical Center
Impact of Positive Airway Pressure Therapy on Clinical Outcomes in Older Veterans With Chronic Obstructive Pulmonary Disease and Comorbid Obstructive Sleep Apnea (Overlap Syndrome)
Obstructive sleep apnea (OSA) and COPD are highly prevalent chronic respiratory diseases in the veteran population. OSA co-occurring with COPD, known as overlap syndrome (OVS), is a complex chronic medical condition associated with grave consequences. OVS is highly prevalent in veterans. Veterans with OVS may be at increased risk for cognitive deficits, poor sleep quality as well as a reduced quality of life (QoL). The overall objective is to study the effects of positive airway pressure therapy on clinical outcomes in patients with OVS.
ID: NCT04179981
Sponsor; Investigator: VA Office of Research and Development; Susmita Chowdhuri, MD, MS
Locations: VA Ann Arbor Healthcare System; John D. Dingell VA Medical Center, Detroit
Developing an Intervention to Optimize Virtual Care Adoption for COPD Management (VC-OPTIONS)
VA is a leader in virtual care (VC), including the patient portal, mobile apps, and telehealth programs. VC has great utility for managing chronic conditions like COPD. However, adoption of many VC services has been slow. Lack of awareness about these services is one of the most prominent patient- and health care team-facing barriers to adopting VC. This study will develop, refine, and pilot a stakeholder-informed multicomponent implementation strategy to support adoption of VC, referred to as VC-OPTIONS (Virtual Care for Chronic Obstructive Pulmonary Disease Adoption Support). This feasibility trial will pilot the VC-OPTIONS implementation strategy to assess feasibility and acceptability and gather preliminary effectiveness data to inform a larger hybrid effectiveness-implementation trial. The core component of VC-OPTIONS will be the provision of information via VA's Annie texting program to empower patients with knowledge about the array of VC services and how they can be used to support COPD management. It is hypothesized that this strategy will be acceptable and feasible. This work will improve patient and team awareness of and communication about VC services, and support patient access to VC services for COPD management.
ID: NCT05986214
Sponsor; Collaborators: VA Office of Research and Development; Stephanie Robinson, PhD
Location: VA Bedford Healthcare System, Massachusetts; VA Boston Healthcare System Jamaica Plain Campus
Chronic Lung Disease and COVID-19: Understanding Severity, Recovery and Rehabilitation Needs (LAUREL)
This study is comprised of 3 approaches. First, the investigators will conduct a retrospective cohort study to determine factors associated with COVID-19 severity and complications and understand COVID-19 outcomes, including all-cause mortality, postdischarge events, and impacts of rehabilitation services (third aim). The second aim is a mixed-method study and follows COVID-19 patients with repeated surveys to determine patient-reported functional outcomes, health recovery, and rehabilitation needs after COVID-19. The investigators will recruit patients and their informal caregivers for interviews to assess their function and rehabilitation needs.
ID: NCT04628039
Sponsor; Collaborators: VA Office of Research and Development; Kristina A. Crothers, MD
Locations: VA Ann Arbor Healthcare System; VA Puget Sound Health Care System, Washington
Accessing Mobility Using Wearable Sensors
This study will examine whether wearable sensors can be used to track changes in cognitive-motor performance in response to a disease or an intervention. The investigators specific aims are twofold, first aim to explore whether and how a clinical condition such as chronic obstructive pulmonary disease (COPD) or congestive heart failure (CHF) may impact motor-cognitive performance measurable using validated wearable devices (eg, LEGSys, BalanSENS, and Frailty Meter). Second, the investigators will explore whether an exercise intervention provided via telemedicine (telerehabilitation) can enhance motor-cognitive performance.
ID: NCT04306588
Sponsor; Collaborators: Baylor College of Medicine, Bijan Najafi, PhD
Locations: Michael E. DeBakey Veterans Affairs Medical Center, Houston
