Digital Inhaler Use in Obstructive Lung Disease Care

Cedars-Sinai Medical Center

Status: Not yet enrolling

Conditions: Chronic Obstructive Airway Disease; Chronic Obstructive Airways Disease Exacerbated

Treatments: Device: Digital Inhaler Attachment

Study type: Interventional

Funder types: Other

Identifiers

NCT07214337

STUDY00004080

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Digital Inhaler Attachment for Regular Care

Other group

Description:

This group of patients will be provided interactive device that provides inhaler coaching for to use for 6 month duration.

Treatment:

Device: Digital Inhaler Attachment