Exploring the Benefits of a 3D-Printed Aerosolized Medication Delivery Assist Device in Patients With Chronic Respiratory Diseases
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
- 否
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
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
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
Ke-Yun, Chao
Group leader of Respiratory Therapists
Fu Jen Catholic University
