跳至主要内容
临床试验/NCT07848087
NCT07848087尚未招募不适用

The Effects of a Respiratory Assistive Device Health Education Manual on Readmission Rates and Self-Care Efficacy: A Randomized Controlled Trial

Fu Jen Catholic University Hospital0 个研究点目标入组 80 人开始时间: 2026年9月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
80
主要终点
Readiness for Hospital Discharge Scale (RHDS) Score

研究概览

简要总结

This study evaluates whether adding an easy-to-read, illustrated education booklet to routine discharge planning helps patients and their family caregivers safely use home respiratory equipment.

Patients who need breathing devices after leaving the hospital often face challenges managing equipment and recognizing warning symptoms, which can lead to complications or hospital readmissions. Participants in this study are randomly assigned (by chance) to one of two groups: one group receives standard hospital discharge instructions, while the other group receives the standard instructions along with a specialized, step-by-step respiratory care booklet. Researchers will assess how prepared patients feel to return home the day before discharge, and will follow up by phone one week later to check on device use, daily care confidence, and any unexpected doctor or emergency room visits.

研究设计

研究类型
干预性
分配方式
随机
干预模型
平行分组
主要目的
卫生服务研究
盲法
开放(无盲法)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • Hospitalized patients enrolled in the discharge planning service of Fu Jen Catholic University Hospital who are evaluated as requiring referral to respiratory assistive devices, long-term care services, or home respiratory care facilities/resources.
  • Evaluated and confirmed by the hospital healthcare team as in need of discharge planning services specifically related to respiratory assistive devices.
  • Aged 18 years or older.
  • Able to comprehend the study purpose and provide written informed consent (if the patient is unable to communicate or express consent, a primary caregiver may provide consent and complete responses on their behalf).

排除标准

  • Patients receiving palliative or hospice care with an anticipated life expectancy of less than 1 month.
  • Patients with altered consciousness or dementia who do not have an eligible primary caregiver available to receive education and participate on their behalf.
  • Severe visual impairment or inability to comprehend Chinese text and pictorial materials.
  • Refusal to sign the written informed consent form despite meeting the inclusion criteria.

研究组 & 干预措施

Experimental Group

Experimental

Receives routine discharge planning supplemented with the structured respiratory assistive device health education manual.

干预措施: Structured Discharge Educational Manual for Respiratory Assistive Devices (Behavioral)

Control Group

Active Comparator

Receives routine discharge planning services, including standard oral education and device instructions.

干预措施: Routine Discharge Planning Service (Other)

结局指标

主要结局

Readiness for Hospital Discharge Scale (RHDS) Score

时间窗: 1 day prior to hospital discharge

Assessed using the Chinese version of the Readiness for Hospital Discharge Scale (RHDS). The scale consists of 23 items across four dimensions: personal status, knowledge, coping ability, and expected support. Item 1 is a dichotomous question ("Yes/No") regarding readiness for discharge, while the remaining 22 items are rated on an 11-point numeric scale ranging from 0 to 10 (with Items 3 and 6 reverse-scored). Higher total scores indicate a higher level of readiness for hospital discharge.

次要结局

  • Home Readiness Score for Respiratory Assistive Devices(1 week after hospital discharge)
  • Assistive Technology Satisfaction Score (T-QUEST 2.0)(1 week after hospital discharge)
  • Utilization Rate of Respiratory Assistive Devices(1 week after hospital discharge)
  • Hospital Readmission Rate(At 7 days and 30 days post-discharge)

研究者

申办方类型
其他
责任方
申办方

标识符

NCT 编号
NCT07848087
其他研究编号
FJUH115608

日期

首次提交
(7天前)
首次发布
(昨天)
主要完成日期
(10个月后)
研究完成日期
(10个月后)
最近核实
(29天前)
最近更新
(昨天)

监管与共享

FDA 监管药物
否
FDA 监管器械
否
个体参与者数据共享计划
UNDECIDED
是否有结果
否