3D-Printed Aerosolized Medication Delivery Assist Device in Patients With Chronic Respiratory Diseases

Fu Jen Catholic University

Status: Enrolling

Conditions: Chronic Pulmonary Disease

Treatments: Device: Use soft mist inhaler with a 3D assistive device; Other: Use soft mist inhaler

Study type: Interventional

Funder types: Other

Identifiers

NCT06315374

FJUH112267

Details and patient eligibility

About

The purpose of this study is to investigate the auxiliary benefits of three-dimensional printed activating assistive devices for soft-mist inhaler on patients' utilization habit.

Full description

Background： The most common treatment for chronic respiratory diseases is inhalation therapy. However, inhalation therapy requires not only correct operating skills, but also exemplary and sustained adherence from the patient. Soft-mist inhaler does not require hand-mouth coordination or minimum inhalation flow rate, and the aerosol release time is longer, which can effectively deliver more medication to the respiratory tract. If the patient is unable to operate the soft-mist inhaler correctly due to abnormal finger joints or weakened hand muscles, it may affect the effectiveness of inhalation.

Study Design： This is a one-year, single-centre, prospective randomized controlled, crossover trial.

Methods： This study will be conducted in the Chest Medicine Education Room on the 2nd floor of Fu Jen Catholic University Hospital. A total of 60 participants will be recruited and randomly assigned into two groups: the control group and the experimental group. Data collection will be conducted after one month of intervention, followed by a crossover trial. Data will be collected again after the second month of intervention, and statistical analysis will be performed.

Effect： This study expect that three-dimensional printed activating assistive devices for soft-mist inhaler will enhance the satisfaction and convenience of elderly patients with chronic respiratory diseases who use soft-mist inhaler, thereby increasing their medication adherence.

Enrollment: 60 estimated patients

Sex: All

Ages: 45 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 45-80 years
• Patients diagnosed with chronic respiratory diseases requiring the use of SMI medication by a physician
• Signed informed consent form

Exclusion criteria

• Not a first-time user of SMI medication
• Requires assistance from others (primary caregiver or nurse) for the operation of SMI medication
• Refusal to participate in the trial

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Simply using soft mist inhaler

Active Comparator group

Description:

Routine use of soft mist inhaler only

Treatment:

Other: Use soft mist inhaler

Use soft mist inhaler with a 3D assistive device

Experimental group

Description:

Use soft mist inhaler with a 3D-printed assist device

Treatment:

Device: Use soft mist inhaler with a 3D assistive device