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| Name | Class |
|---|---|
| Breathe California, Los Angeles County | OTHER |
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This is a pilot study to evaluate the role digital inhaler technology on patients with obstructive lung disease in preventing admissions and exacerbation, as well as improving symptom control. The primary objective is to evaluate feasibility of study protocol, patient recruitment, and patient retention with goal recruitment of 20 participants, 60% recruitment success, and 60% retention rate for 6 months duration. The secondary objectives are the evaluation of patient admission rate, exacerbation rates, and symptoms control with use of digital inhaler technology The subject population will be patients with physician diagnosed obstructive lung disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Digital Inhaler Attachment for Regular Care | Other | This group of patients will be provided interactive device that provides inhaler coaching for to use for 6 month duration. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital Inhaler Attachment | Device | This intervention is the attachment of a digital device to provide patient with coaching for optimal inhaler use and technique, as well as monitoring of patient use of inhaler to patient and health care team. Patient will continue to use inhalers prescribed as per usual care for management of COPD. |
| Measure | Description | Time Frame |
|---|---|---|
| Participant Recruitment Percentage | The investigators will be looking at what percentage of patients approached for recruitment choose to participate in the study. Accrual rate will be computed as the proportion of subjects enrolled as a function of the number of subjects screened. | 6 months |
| Participant Retention Percentage | The investigators will also be looking at what percentage patient who choose to participate remain participating for the full 6-month duration of the study period. The retention rate over the full 6-month period of follow-up will be computed among enrolled subjects. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Re-admission Rate | Hospital re-admission rate for COPD exacerbation during study period | 6 months |
| COPD Exacerbation Rates | Rates of COPD exacerbation after intervention during study period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vinita Kusupati, MD | Contact | 14016512622 | vinita.kusupati@cshs.org | |
| Sara Ghandehari, MD | Contact | sara.ghandehari@cshs.org |
| Name | Affiliation | Role |
|---|---|---|
| Sara Ghandehari, MD | Cedars-Sinai Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States |
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| Label | URL |
|---|---|
| Related Info | View source |
| Related Info | View source |
| Related Info |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| 6 months |
| Symptom Control | Overall symptoms control of COPD after intervention during study period. This will utilize the COPD Assessment Test. Scores with this test can range from 0 to 40, with higher score representing worse severity of disease and worse symptom control. | 6 months |
| Satisfaction with Device Assessed with Questionnaire | Assessment of patient satisfaction with use of device utilizing questionnaire to be administered at the conclusion of the study. | 6 months |
| Related Info | View source |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |