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

Not Applicable

Recruiting

• Conditions: Chronic Pulmonary Disease
• Interventions: Other: Use soft mist inhaler; Device: Use soft mist inhaler with a 3D assistive device

• Registration Number: NCT06315374
• Lead Sponsor: Fu Jen Catholic University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2024-03-11
• Study First Submitted QC: 2024-03-11
• Study First Posted: 2024-03-18
• Study Start: 2024-03-28
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-24
• Last Update Posted: 2024-12-27
• Primary Completion: 2025-07-31
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Simply using soft mist inhaler	Use soft mist inhaler	Routine use of soft mist inhaler only
Use soft mist inhaler with a 3D assistive device	Use soft mist inhaler with a 3D assistive device	Use soft mist inhaler with a 3D-printed assist device

Primary Outcome Measures

Name	Time	Method
satisfaction survey	1 month after the intervention	feedback and satisfaction regarding the initiation of SMI medication with 3D-printed aerosolized medication delivery assist device (maximun 35 and minimum 7), higher means a better outcome

Trial Locations

Locations (1)

Fu Jen Catholic University Hospital, Fu Jen Catholic University; 🇨🇳 New Taipei City, Taiwan