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Difficulty recruiting patient population.
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| Name | Class |
|---|---|
| University of Arizona | OTHER |
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This is a multicenter, randomized, parallel-group, open label study of the efficacy of AVAPS-AE to prevent re-hospitalization in hospitalized patients with comorbid Chronic Obstructive Pulmonary Disease (COPD).
This is a multicenter, randomized, parallel-group, open label study of the efficacy of AVAPS-AE to prevent re-hospitalization in hospitalized patients with comorbid COPD. Hospitalized patients with comorbid COPD who are at high risk for readmission will be recruited. Specifically patients with comorbid COPD who are to be discharged with (a) admission diagnosis of COPD (GOLD stage II or greater); AND (b) either a prior non-elective hospitalization (one in the past 12 months) OR active smoker. Such participants will undergo questionnaire-based screening for sleep-disordered breathing (STOP-BANG questionnaire) and if they have a high risk for Sleep Disordered Breathing (SDB) (> 3 points) will undergo an overnight portable sleep study for screening prior to hospital discharge (AHI > 10 per hour; >3% oxygen desaturation for hypopneas).
After randomization and prior to discharge, participants will either be initiated on AVAPS-AE therapy (intervention arm) for 60 days or will be referred to the sleep center for further diagnostic testing and therapy initiation (standard of care arm). Participants will complete quality of life questionnaires Functional outcomes of sleep questionnaire (FOSQ) at baseline (in-person), and in 30 and 60 days (by mail) post discharge. Information regarding hospital admission, diagnostic tests, medication changes, and procedures will be collected from all participants. Discharge summaries of re-hospitalizations and office or ER visits, as well as diagnostics tests and therapies received will be collected for measuring healthcare costs.
Participants will have an option to enroll in a registry for a 3 year follow-up and will also be queried on a yearly basis regarding hospitalizations, cardiovascular events, and assessment of vital statistics in the National Death Index registry. The study will conclude when all randomized participants have been followed for a minimum of 60 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AVAPS-AE Non-invasive ventilation therapy | Experimental | Participants will be initiated on AVAPS-AE therapy (intervention arm) for 60 days. AVAPS-AE is a mode of therapy (Philips Respironics Inc, Monroeville, Pa) with potential advantages over the currently established modes of non-invasive positive pressure ventilation (CPAP and bilevel therapy). This mode of therapy incorporates AVAPS (automated adjustable Inspiratory Positive Airway Pressure (IPAP) setting to maintain target ventilation with a settable rate of change), Auto Expiratory Positive Airway Pressure (EPAP) and Auto Back up Rate. |
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| Standard of Care Group | No Intervention | Evaluation and treatment of the participant's sleep disordered breathing will be per their participant's health care provider's usual care pathway. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AVAPS-AE Non-invasive ventilation therapy | Device | Participants will use the device greater than or equal to 4hrs per night for the 60 days after discharge. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Enrolled Requiring Emergent Healthcare (Such as Re-hospitalization, Unscheduled Physician Office Visits, Urgent Care Visits or Emergency Room Visits). | Evaluate the effects of novel application of Averaged Volume Assured Pressure Support (AVAPS-AE) therapy on the number of participants with emergent and non-emergent healthcare utilization with sleep-disordered breathing who are hospitalized with co-morbid Chronic Obstructive Pulmonary Disease (COPD), number of participants enrolled. | 60 days post-discharge |
| Composite End-point of Time (# of Days) to Occurrence of Emergent Healthcare Utilization (Such as Re-hospitalization, Unscheduled Physician Office Visits, Urgent Care Visits or Emergency Room Visits). | Evaluate the effects of novel application of Averaged Volume Assured Pressure Support (AVAPS-AE) therapy on time to (# of days) emergent and non-emergent healthcare utilization in patients with sleep-disordered breathing who are hospitalized with co-morbid Chronic Obstructive Pulmonary Disease (COPD). | 60 days post-discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Healthcare Costs | Evaluate the effects of novel application of Averaged Volume Assured Pressure Support (AVAPS-AE) therapy on the number of emergent and non-emergent healthcare utilization over 6 months; costs related to re-hospitalization; number of visits to physician offices or emergency rooms, and health-related quality of life (disease-specific and general HR-QOL measures). | 60 days post-discharge |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sairam Parthasarathy, MD | University of Arizona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona | Tucson | Arizona | 85724 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23497021 | Background | Briones Claudett KH, Briones Claudett M, Chung Sang Wong M, Nuques Martinez A, Soto Espinoza R, Montalvo M, Esquinas Rodriguez A, Gonzalez Diaz G, Grunauer Andrade M. Noninvasive mechanical ventilation with average volume assured pressure support (AVAPS) in patients with chronic obstructive pulmonary disease and hypercapnic encephalopathy. BMC Pulm Med. 2013 Mar 12;13:12. doi: 10.1186/1471-2466-13-12. | |
| 20378728 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Screening Period | All participants that signed the consent. |
| FG001 | Standard of Care | Evaluation and treatment of the participant's sleep disordered breathing will be per their participant's health care provider's usual care pathway. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Screening Period |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 8, 2017 |
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| Change in Quality of Life (SF-36) at 30 and 60 Days | Evaluate the effects of novel application of Averaged Volume Assured Pressure Support (AVAPS-AE) therapy on health-related quality of life. The Short Form 36 (SF-36) is a set of quality of life measures. Participants were asked at 30 days and 60 days in general what their overall health was. On a scale of 1 to 5 -1 being excellent, 5 being poor. | 30 and 60 days post-discharge |
| Change in Quality of Life (FOSQ) at 30 and 60 Days | FOSQ is a quality of life questionnaire for sleep disorders. It's a 30 question survey with 5 subgroups: general productivity (8 questions), social outcome (2 questions),activity level (9 questions), vigilance (7 questions) and intimate relationships & sexual activity (4 questions). Scores are provided on a 0 to 4 scale: 0- I don't do this activity for other reasons or missing response 1- Yes, extreme difficulty 4- no difficulty The average score was calculated based upon average sub-scores. The total score was, calculated using the mean of the subscale scores and multiplying the mean by the number of subscales. The range of scores for the total score is 5-20. The measures are designed to assess the impact of disorders of excessive sleepiness on activities of everyday living and the extent to which these abilities are improved by effective treatment. The lower the score the more difficulty a person has carrying out certain activities because they are too sleepy or tired. | 30 and 60 days post-discharge |
| Composite End-point of Time to Occurrence of Non-emergent Healthcare Utilization (Such as Scheduled Hospitalization, Scheduled Physician Office, Urgent Care Visits or Emergency Room Visits). | Evaluate the effects of novel application of Averaged Volume Assured Pressure Support (AVAPS-AE) therapy on the number of emergent and non-emergent healthcare utilization over 6 months; costs related to re-hospitalization; number of visits to physician offices or emergency rooms, and health-related quality of life (disease-specific and general HR-QOL measures). | 6 months |
| Time to Re-hospitalization Alone | Evaluate the effects of novel application of Averaged Volume Assured Pressure Support (AVAPS-AE) therapy on time to re-hospitalization alone. | 60 days post-discharge |
| Number of Hospitalizations Over 3 Years (Optional if Enrolled in Registry) | Evaluate the effects of novel application of Averaged Volume Assured Pressure Support (AVAPS-AE) therapy on the number of emergent and non-emergent healthcare utilization over 6 months; costs related to re-hospitalization; number of visits to physician offices or emergency rooms, and health-related quality of life (disease-specific and general HR-QOL measures). | 3 years |
| Background |
| Marin JM, Soriano JB, Carrizo SJ, Boldova A, Celli BR. Outcomes in patients with chronic obstructive pulmonary disease and obstructive sleep apnea: the overlap syndrome. Am J Respir Crit Care Med. 2010 Aug 1;182(3):325-31. doi: 10.1164/rccm.200912-1869OC. Epub 2010 Apr 8. |
| 19339721 | Background | Jencks SF, Williams MV, Coleman EA. Rehospitalizations among patients in the Medicare fee-for-service program. N Engl J Med. 2009 Apr 2;360(14):1418-28. doi: 10.1056/NEJMsa0803563. |
| 12098520 | Background | Westert GP, Lagoe RJ, Keskimaki I, Leyland A, Murphy M. An international study of hospital readmissions and related utilization in Europe and the USA. Health Policy. 2002 Sep;61(3):269-78. doi: 10.1016/s0168-8510(01)00236-6. |
| FG002 | Experimental: AVAPS-AE Non-invasive Ventilation Therapy | Participants will be initiated on AVAPS-AE therapy (intervention arm) for 60 days. AVAPS-AE is a mode of therapy (Philips Respironics Inc, Monroeville, Pa) with potential advantages over the currently established modes of non-invasive positive pressure ventilation (CPAP and bilevel therapy). This mode of therapy incorporates AVAPS (automated adjustable Inspiratory Positive Airway Pressure (IPAP) setting to maintain target ventilation with a settable rate of change), Auto Expiratory Positive Airway Pressure (EPAP) and Auto Back up Rate. |
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Due to the low enrollment, and low number of participants randomized into the study baseline analysis population description data was combined to provide more purposeful data.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | All participants that were consented. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m^2 |
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| Current Smokers | Count of Participants | Participants |
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| Gold Stage | GOLD is the Global Initiative for Chronic Obstructive Lung Disease stage or grade. Doctors assign grades based on four separate pieces of information: How severe your current symptoms are, your spirometry results,the chances that your COPD will get worse, and the presence of other health problems. The higher the stage the more severe the COPD. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants Enrolled Requiring Emergent Healthcare (Such as Re-hospitalization, Unscheduled Physician Office Visits, Urgent Care Visits or Emergency Room Visits). | Evaluate the effects of novel application of Averaged Volume Assured Pressure Support (AVAPS-AE) therapy on the number of participants with emergent and non-emergent healthcare utilization with sleep-disordered breathing who are hospitalized with co-morbid Chronic Obstructive Pulmonary Disease (COPD), number of participants enrolled. | Posted | Count of Participants | Participants | 60 days post-discharge |
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| Primary | Composite End-point of Time (# of Days) to Occurrence of Emergent Healthcare Utilization (Such as Re-hospitalization, Unscheduled Physician Office Visits, Urgent Care Visits or Emergency Room Visits). | Evaluate the effects of novel application of Averaged Volume Assured Pressure Support (AVAPS-AE) therapy on time to (# of days) emergent and non-emergent healthcare utilization in patients with sleep-disordered breathing who are hospitalized with co-morbid Chronic Obstructive Pulmonary Disease (COPD). | Only one participant enrolled in the study required emergent healthcare utilization. | Posted | Mean | Standard Deviation | days | 60 days post-discharge |
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| Secondary | Healthcare Costs | Evaluate the effects of novel application of Averaged Volume Assured Pressure Support (AVAPS-AE) therapy on the number of emergent and non-emergent healthcare utilization over 6 months; costs related to re-hospitalization; number of visits to physician offices or emergency rooms, and health-related quality of life (disease-specific and general HR-QOL measures). | Data was not collected as study was terminated. | Posted | 60 days post-discharge |
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| Secondary | Change in Quality of Life (SF-36) at 30 and 60 Days | Evaluate the effects of novel application of Averaged Volume Assured Pressure Support (AVAPS-AE) therapy on health-related quality of life. The Short Form 36 (SF-36) is a set of quality of life measures. Participants were asked at 30 days and 60 days in general what their overall health was. On a scale of 1 to 5 -1 being excellent, 5 being poor. | Posted | Mean | Standard Deviation | units on a scale | 30 and 60 days post-discharge |
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| Secondary | Change in Quality of Life (FOSQ) at 30 and 60 Days | FOSQ is a quality of life questionnaire for sleep disorders. It's a 30 question survey with 5 subgroups: general productivity (8 questions), social outcome (2 questions),activity level (9 questions), vigilance (7 questions) and intimate relationships & sexual activity (4 questions). Scores are provided on a 0 to 4 scale: 0- I don't do this activity for other reasons or missing response 1- Yes, extreme difficulty 4- no difficulty The average score was calculated based upon average sub-scores. The total score was, calculated using the mean of the subscale scores and multiplying the mean by the number of subscales. The range of scores for the total score is 5-20. The measures are designed to assess the impact of disorders of excessive sleepiness on activities of everyday living and the extent to which these abilities are improved by effective treatment. The lower the score the more difficulty a person has carrying out certain activities because they are too sleepy or tired. | Posted | Mean | Standard Deviation | units on a scale | 30 and 60 days post-discharge |
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| Secondary | Composite End-point of Time to Occurrence of Non-emergent Healthcare Utilization (Such as Scheduled Hospitalization, Scheduled Physician Office, Urgent Care Visits or Emergency Room Visits). | Evaluate the effects of novel application of Averaged Volume Assured Pressure Support (AVAPS-AE) therapy on the number of emergent and non-emergent healthcare utilization over 6 months; costs related to re-hospitalization; number of visits to physician offices or emergency rooms, and health-related quality of life (disease-specific and general HR-QOL measures). | Posted | Mean | Standard Deviation | days | 6 months |
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| Secondary | Time to Re-hospitalization Alone | Evaluate the effects of novel application of Averaged Volume Assured Pressure Support (AVAPS-AE) therapy on time to re-hospitalization alone. | Only one enrolled participation was hospitalized. | Posted | Mean | Standard Deviation | days | 60 days post-discharge |
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| Secondary | Number of Hospitalizations Over 3 Years (Optional if Enrolled in Registry) | Evaluate the effects of novel application of Averaged Volume Assured Pressure Support (AVAPS-AE) therapy on the number of emergent and non-emergent healthcare utilization over 6 months; costs related to re-hospitalization; number of visits to physician offices or emergency rooms, and health-related quality of life (disease-specific and general HR-QOL measures). | No participants were enrolled in the registry. | Posted | 3 years |
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60 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Screening Period | All participants that signed the consent. | 0 | 18 | 0 | 18 | 0 | 18 |
| EG001 | Standard of Care | Evaluation and treatment of the participant's sleep disordered breathing will be per their participant's health care provider's usual care pathway. | 0 | 4 | 0 | 4 | 0 | 4 |
| EG002 | Experimental: AVAPS-AE Non-invasive Ventilation Therapy | Participants will be initiated on AVAPS-AE therapy (intervention arm) for 60 days. AVAPS-AE is a mode of therapy (Philips Respironics Inc, Monroeville, Pa) with potential advantages over the currently established modes of non-invasive positive pressure ventilation (CPAP and bilevel therapy). This mode of therapy incorporates AVAPS (automated adjustable IPAP setting to maintain target ventilation with a settable rate of change), Auto EPAP and Auto Back up Rate. | 0 | 3 | 1 | 3 | 0 | 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperkalemia | Cardiac disorders | Non-systematic Assessment |
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| Cardiac Arrhythmia | Cardiac disorders | Non-systematic Assessment |
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| Acute Kidney Infection | Renal and urinary disorders | Non-systematic Assessment |
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| Fall secondary loss of consciousness | General disorders | Non-systematic Assessment |
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Enrollment was terminated early due to a high number of screen failures therefore data analysis with any statistical significance could not be performed.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chuck Cain | Philips | 412-542-3605 | chuck.cain@philips.com |
| May 17, 2019 |
| Prot_SAP_000.pdf |
| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Gold Stage IIII |
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| Unknown |
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| OG001 | Standard of Care Group | Evaluation and treatment of the participant's sleep disordered breathing will be per their participant's health care provider's usual care pathway. |
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