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

Chronic Pulmonary Disease Clinical Trial

Official title:

Exploring the Benefits of a 3D-Printed Aerosolized Medication Delivery Assist Device in Patients With Chronic Respiratory Diseases

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06315374
• Other study ID #: FJUH112267
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 30, 2024
• Est. completion date: July 31, 2024

Study information

• Verified date: March 2024
• Source: Fu Jen Catholic University
• Contact: Ke-Yun Chao
• Phone: +886-905-301-879
• Email: C00152[@]mail.fjuh.fju.edu.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pulmonary Disease
• Respiration Disorders
• Respiratory Tract Diseases

Intervention

Other:
• Use soft mist inhaler
Only use soft mist inhaler

Device:
• Use soft mist inhaler with a 3D assistive device
Use soft mist inhaler with a 3D-printed assist device

Locations

Country	Name	City	State
Taiwan	Fu Jen Catholic University Hospital, Fu Jen Catholic University	New Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
Fu Jen Catholic University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	satisfaction survey	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	1 month after the intervention