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临床试验/NCT06315374
NCT06315374撤回不适用

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

Fu Jen Catholic University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年3月28日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
入组人数
60
试验地点
1
主要终点
satisfaction survey

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
None

入排标准

年龄范围
45 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 45-80 years
  • Patients diagnosed with chronic respiratory diseases requiring the use of SMI medication by a physician
  • Signed informed consent form

排除标准

  • 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

研究组 & 干预措施

Simply using soft mist inhaler

Active Comparator

Routine use of soft mist inhaler only

干预措施: Use soft mist inhaler (Other)

Use soft mist inhaler with a 3D assistive device

Experimental

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

干预措施: Use soft mist inhaler with a 3D assistive device (Device)

结局指标

主要结局

satisfaction survey

时间窗: 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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ke-Yun, Chao

Group leader of Respiratory Therapists

Fu Jen Catholic University

研究点 (1)

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