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临床试验/NCT05008211
NCT05008211已完成不适用

Effectiveness of an Information-Motivation-Behavioral Skills Model-based Intervention on Adherence to Domiciliary Non-invasive Ventilation of Patients With Chronic Hypercapnic Respiratory Failure: A Randomized Controlled Study

The University of Hong Kong1 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2021年9月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
124
试验地点
1
主要终点
Domiciliary NIV adherence

研究概览

简要总结

Domiciliary non-invasive ventilation (NIV) is a standard care for improving survival rates of selected patients with chronic hypercapnic respiratory failure (CHRF) and to improve the patients' hypercapnia, sleep quality, health-related quality of life (QoL). Adherence is an important factor affecting clinical effectiveness of domiciliary NIV. Our previous study has noted the associations between poor domiciliary NIV adherence and increased number of clinical adverse events (p = 0.004) and increased hospitalization requiring acute NIV salvage (p = 0.042). However, there are very limited studies on adherence to domiciliary NIV in patients with CHRF. The only interventional study was a single-group pre-test post-test study and lack of a theoretical framework for guiding the intervention. This study is employing an Information-Motivation-Behavioral skills (IMB) model-based intervention to improve inhalation adherence in a group of chronic obstructive pulmonary disease (COPD) patients.

详细描述

The study design is a multi-center, 2-arm single-blind randomized controlled trial. The intervention group will receive an Information-Motivation-Behavioral (IMB) model-based intervention while the control group will receive the usual care.

Usual Care: There is a respiratory team of health care professionals responsible for patients requiring domiciliary non-invasive ventilation (NIV). The team is led by a Medical Consultant and with respiratory nurse(s) as team members who are responsible for assisting patients or their family to initiate domiciliary NIV and teaching the relevant technical skills. The nurse will provide an one-hour face-to-face session to introduce the choices of domiciliary NIV and teach the patient or his/her family on how to operate and maintain the ventilator, interface and accessories, and also how to handle the common problems such as leakage and pressure sore in hospital before discharge. Commercial leaflet or booklet according to the choice of ventilator with information of the ventilator, interface, accessories and the ventilator company will be provided to the patient.

Intervention:

There will be a respiratory team, same as the usual care, responsible for patients requiring domiciliary NIV in the intervention group. The IMB model-based intervention of this study is a six-week program consisted of a one-hour face-to-face home visit in the first week, two 20-minute telephone follow-ups in the second and fourth weeks, and a half-hour face-to-face follow-up at hospital in the sixth week, and a telephone consultation hotline during office hours.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Outcomes Assessor)

入排标准

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

入选标准

  • (1) CHRF (i.e., PaCO2 ≥ 7 kPa or 52.5 mmHg) for at least 4 weeks, and
  • (2) using domiciliary NIV for ≥ 4 weeks, and
  • (3) non-adherer (i.e., used domiciliary NIV for < 4 hours per night or < 70% of days or with a mean daily use < 5 hours per day in the last 2 weeks)

排除标准

  • (1) known psychiatric disorders except anxiety and depression; or
  • (2) diseases limiting life expectancy to ≤ one year; or
  • (3) active malignancy

结局指标

主要结局

Domiciliary NIV adherence

时间窗: 12th month

the records from the software fitted on the subject's NIV machine for the past two weeks will be reviewed to determine adherence or non-adherence, and assessed for the percentage of days with usage of at least 4 hours per night and the mean of daily use.

次要结局

  • Venous bicarbonate (HCO3-) level(6th month)
  • Chinese Pittsburgh Sleep Quality Index (CPSQI)(12th month)
  • Chinese Severe Respiratory Insufficiency questionnaire (CSRI)(12th month)
  • Hospital admissions and survival rate(12th month)

研究者

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

Prof. Yu, Doris Sau Fung

Professor

The University of Hong Kong

研究点 (1)

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