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

NCT ID: NCT06315374

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-28

Study Completion Date

2025-07-31

Brief Summary

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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

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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.

Conditions

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Chronic Pulmonary Disease

Keywords

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Soft mist inhaler device error hand strength finger muscle power coordination

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Simply using soft mist inhaler

Routine use of soft mist inhaler only

Group Type ACTIVE_COMPARATOR

Use soft mist inhaler

Intervention Type OTHER

Only use soft mist inhaler

Use soft mist inhaler with a 3D assistive device

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

Group Type EXPERIMENTAL

Use soft mist inhaler with a 3D assistive device

Intervention Type DEVICE

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

Interventions

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Use soft mist inhaler

Only use soft mist inhaler

Intervention Type OTHER

Use soft mist inhaler with a 3D assistive device

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fu Jen Catholic University

OTHER

Sponsor Role lead

Responsible Party

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Ke-Yun, Chao

Group leader of Respiratory Therapists

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ke-Yun Chao, PhD

Role: PRINCIPAL_INVESTIGATOR

Fu Jen Catholic University Hospital

Locations

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Fu Jen Catholic University Hospital, Fu Jen Catholic University

New Taipei City, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Ke-Yun Chao

Role: CONTACT

Phone: +886-905-301-879

Email: [email protected]

Facility Contacts

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Ke-Yun Chao, PhD

Role: primary

Other Identifiers

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FJUH112267

Identifier Type: -

Identifier Source: org_study_id