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| Name | Class |
|---|---|
| AirCare Labs, LLC | UNKNOWN |
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Sleep apnea, characterized by abnormal breathing at night, is often untreated in patients with heart failure. Helping patients to effectively use the most common form of treatment for sleep apnea, positive airway pressure therapy, can improve their heart function. This can reduce the likelihood that the patient will be re-admitted to the hospital. AirCareLabs has developed an innovative solution that allows patients to communicate with health care providers 24 hours a day, thus allowing them to get the help they need to effectively use positive airway pressure and thereby reduce the risk of being re-admitted to the hospital.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Study participants will receive a tablet computer with the AirCare system. |
|
| Control | No Intervention | Standard care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AirCare App | Behavioral | Tablet software to encourage adherence and support |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Adhering to Positive Airway Pressure (PAP) | PAP adherence will be measured from the PAP unit (which monitors nightly hours of use and records this data; this is the standard of care clinical practice approach used currently by health care providers to monitor PAP use) and will be reported as Number of Participants who Adhered to Positive Airway Pressure (PAP) Treatment (adherence defined as >4 hours of use per night on average across the 30 day period). For example, if 5 subjects used PAP for more than 4 hours per night on average across the 30 day period, then the number of adherent participants is 5. | one month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nalaka Gooneratne, MD | University of Pennsylvania | Study Director |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention: AirCare System | Study participants will receive a tablet computer with the AirCare system. AirCare App: Tablet software to encourage adherence and support |
| FG001 | Control: Standard of Care | Standard care consisting of routine clinical care provided by their healthcare providers |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Patients admitted with heart failure
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention: AirCare System | Study participants will receive a tablet computer with the AirCare system. AirCare App: Tablet software to encourage adherence and support |
| BG001 | Control: Standard of Care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 Adhering to Positive Airway Pressure (PAP) | PAP adherence will be measured from the PAP unit (which monitors nightly hours of use and records this data; this is the standard of care clinical practice approach used currently by health care providers to monitor PAP use) and will be reported as Number of Participants who Adhered to Positive Airway Pressure (PAP) Treatment (adherence defined as >4 hours of use per night on average across the 30 day period). For example, if 5 subjects used PAP for more than 4 hours per night on average across the 30 day period, then the number of adherent participants is 5. | Intent to treat | Posted | Count of Participants | Participants | one month |
|
One month
Adverse events were collected at the one month follow-up visit
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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 | Intervention: AirCare System | Study participants will receive a tablet computer with the AirCare system. AirCare App: Tablet software to encourage adherence and support |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Aortic Stenosis | Cardiac disorders | Systematic Assessment | Related? (U=Unrelated, R=Related): U / Expected? Y |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary Tract Infection | Infections and infestations | Systematic Assessment | Related? (U=Unrelated, R=Related): U / Expected? Y |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Nalaka Gooneratne | University of Pennsylvania | 215 573 2048 | ngoonera@upenn.edu |
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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 | Dec 1, 2018 | Aug 26, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D012891 | Sleep Apnea Syndromes |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
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Standard care: This is the care that would be routinely provided by their healthcare provider
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Apnea Hypopnea Index (AHI, events/hr) | The number of apnea (cessation of breathing) or hypopnea (reduction of breathing) events as defined by the American Academy of Sleep Medicine. Lowest possible value is 0 events per hour. Higher values indicate more frequent apnea or hypopnea events. | Mean | Standard Deviation | events/hr |
|
| OG001 | Control: Standard Care | Standard care: This is the care that would be routinely provided by their healthcare provider |
|
|
|
| 3 |
| 74 |
| 17 |
| 74 |
| 1 |
| 74 |
| EG001 | Control: Standard Care | Standard care: This is the care that would be routinely provided by their healthcare provider | 4 | 72 | 17 | 72 | 4 | 72 |
|
| Atrial Fibrillation | Cardiac disorders | Systematic Assessment | Related? (U=Unrelated, R=Related): U / Expected? Y |
|
| CAD | Cardiac disorders | Systematic Assessment | Related? (U=Unrelated, R=Related): U / Expected? Y |
|
| Cardiac Arrest | Cardiac disorders | Systematic Assessment | Related? (U=Unrelated, R=Related): U / Expected? Y |
|
| CHF | Cardiac disorders | Systematic Assessment | Related? (U=Unrelated, R=Related): U / Expected? Y |
|
| Hypotension | Cardiac disorders | Systematic Assessment | Related? (U=Unrelated, R=Related): U / Expected? Y |
|
| Pacemaker bleeding | Cardiac disorders | Systematic Assessment | Related? (U=Unrelated, R=Related): U / Expected? Y |
|
| Pacemaker malfunction | Cardiac disorders | Systematic Assessment | Related? (U=Unrelated, R=Related): U / Expected? Y |
|
| PVT | Cardiac disorders | Systematic Assessment | Related? (U=Unrelated, R=Related): U / Expected? Y |
|
| Abdominal Pain | Gastrointestinal disorders | Systematic Assessment | Related? (U=Unrelated, R=Related): U / Expected? Y |
|
| Abnormal Liver Enzymes | Gastrointestinal disorders | Systematic Assessment | Related? (U=Unrelated, R=Related): U / Expected? Y |
|
| GI Bleed | Gastrointestinal disorders | Systematic Assessment | Related? (U=Unrelated, R=Related): U / Expected? Y |
|
| Sepsis | Infections and infestations | Systematic Assessment | Related? (U=Unrelated, R=Related): U / Expected? Y |
|
| SIRS | Infections and infestations | Systematic Assessment | Related? (U=Unrelated, R=Related): U / Expected? Y |
|
| Gout | Musculoskeletal and connective tissue disorders | Systematic Assessment | Related? (U=Unrelated, R=Related): U / Expected? Y |
|
| Hypokalemia | Metabolism and nutrition disorders | Systematic Assessment | Related? (U=Unrelated, R=Related): U / Expected? Y |
|
| Metabolic Acidosis | Metabolism and nutrition disorders | Systematic Assessment | Related? (U=Unrelated, R=Related): U / Expected? Y |
|
| CVA | Nervous system disorders | Systematic Assessment | Related? (U=Unrelated, R=Related): U / Expected? Y |
|
| Neuropathy | Nervous system disorders | Systematic Assessment | Related? (U=Unrelated, R=Related): U / Expected? Y |
|
| Seizure | Nervous system disorders | Systematic Assessment | Related? (U=Unrelated, R=Related): U / Expected? Y |
|
| Stroke | Nervous system disorders | Systematic Assessment | Related? (U=Unrelated, R=Related): U / Expected? Y |
|
| Syncope | Nervous system disorders | Systematic Assessment | Related? (U=Unrelated, R=Related): U / Expected? Y |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Related? (U=Unrelated, R=Related): U / Expected? Y |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Related? (U=Unrelated, R=Related): U / Expected? Y |
|
| Pulmonary Hypertension | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Related? (U=Unrelated, R=Related): U / Expected? Y |
|
| Kidney infection | Renal and urinary disorders | Systematic Assessment | Related? (U=Unrelated, R=Related): U / Expected? Y |
|
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment | Related? (U=Unrelated, R=Related): U / Expected? Y |
|
| Toothache | General disorders | Systematic Assessment | Related? (U=Unrelated, R=Related): U / Expected? Y |
|
| Atrial Fibrillation | Cardiac disorders | Systematic Assessment | Related? (U=Unrelated, R=Related): U / Expected? Y |
|
| Lightheadedness | Nervous system disorders | Systematic Assessment | Related? (U=Unrelated, R=Related): U / Expected? Y |
|
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| D012140 |
| Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |