Chronic Obstructive Airway Disease, Chronic Obstructive Airways Disease Exacerbated
Conditions
Keywords
Chronic Obstructive Airways Disease, COPD, COPD Exacerbation, Severe COPD, Moderate COPD, Severe Chronic Obstructive Airways Disease, Moderate Chronic Obstructive Airways Disease
Brief summary
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.
Interventions
DEVICEDigital Inhaler Attachment
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.
Sponsors
Breathe California, Los Angeles County
Cedars-Sinai Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Any sex * Over the age of 18 years. * Physician-diagnosed obstructive lung disease * Speak, read, and understand English. * The current study is a feasibility pilot. Based on the results of the study, future studies will include non-English speakers as well. * Able to understand study requirements and comply with study procedures. * Ability to operate a smartphone or tablet (for questionnaire and symptoms input). * Patients who use either a DPI or an MDI device as controller medications. Medications will not be changed by the study team.
Exclusion criteria
* Physically disabled such that they are incapable of using digital devices or metered dose inhalers. * Suffer from any visual, hearing or cognitive impairment that cannot be corrected enough to operate the devices properly. Mild/moderate vision loss and mild hearing loss may be included with appropriate corrective measures that do not affect the device usage. * Suffering from serious uncontrolled medical conditions that may interfere with study conduct. * Inability or unwillingness of the participant to give written informed consent. * Pregnant women (due to complicated physiology) * The current study is a feasibility pilot. Based on the results of the study, future studies will likely include pregnant patients as well. * Prisoners
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participant Retention Percentage | 6 months | 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. |
| Participant Recruitment Percentage | 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Re-admission Rate | 6 months | Hospital re-admission rate for COPD exacerbation during study period |
| COPD Exacerbation Rates | 6 months | Rates of COPD exacerbation after intervention during study period |
| Symptom Control | 6 months | 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. |
| Satisfaction with Device Assessed with Questionnaire | 6 months | Assessment of patient satisfaction with use of device utilizing questionnaire to be administered at the conclusion of the study. |
Countries
United States
Contacts
Primary ContactVinita Kusupati, MD
Backup ContactSara Ghandehari, MD
Outcome results
None listed