Chronic Pulmonary Disease
Conditions
Keywords
Soft mist inhaler, device error, hand strength, finger muscle power, coordination
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.
Interventions
OTHERUse soft mist inhaler
Only use soft mist inhaler
DEVICEUse soft mist inhaler with a 3D assistive device
Use soft mist inhaler with a 3D-printed assist device
Sponsors
Fu Jen Catholic University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Taiwan
Contacts
PRINCIPAL_INVESTIGATORKe-Yun Chao, PhD
Fu Jen Catholic University Hospital
Outcome results
None listed