Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06315374
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-19
First Post:
2024-03-11
Brief Title:
3D-Printed Aerosolized Medication Delivery Assist Device in Patients With Chronic Respiratory Diseases
Sponsor:
Fu Jen Catholic University
Organization:
Fu Jen Catholic University
Study Overview
Official Title:
Exploring the Benefits of a 3D-Printed Aerosolized Medication Delivery Assist Device in Patients With Chronic Respiratory Diseases
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None