Impact of Remote Vital Signs Monitoring in People Using Long-term Oxygen Therapy : a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Health-related quality of life (HRQOL): assessed using the EQ-5D-5L Questionnaire
研究概览
简要总结
Assess quality of life of patients using prolonged oxygen therapy
详细描述
Adult participants of both sexes with COPD and PID, prolonged oxygen use, will be evaluated after being informed about the study, agreeing and signing the informed consent form. Participants will be randomized to a control group and a group monitored for 90 days. The monitored group will receive a wearable device to monitor vital signs of heart rate and oxygen saturation and the control group will receive a pulse oximeter. Both groups will be monitored through the cell phone application.
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 (Investigator, Outcomes Assessor)
盲法说明
Randomizations will be carried out blindly, that is, by an evaluator who will not be directly involved in the intervention.
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a clinical, radiological and/or anatomopathological diagnosis of COPD and ILD according to the 2020 ATS/JRS/ALAT guidelines;
- •Age over 18 years;
- •Clinical stability (absence of exacerbations or hospitalizations related to the underlying disease) for at least 6 weeks;
- •Patients who are on optimized drug therapy, including long-term home oxygen therapy (LTOT)
- •Have a smartphone compatible with the monitoring device;
- •Signing of the ICF to participate in the study.
排除标准
- •Presence of other concomitant lung diseases;
- •Myocardial infarction within four months prior to the start of the study, unstable angina or severe heart disease (NYHA functional class III-IV) and/or decompensated.
- •Patients who received a lung transplant during the study
- •Living outside the coverage area or moving out of state
结局指标
主要结局
Health-related quality of life (HRQOL): assessed using the EQ-5D-5L Questionnaire
时间窗: Change from baseline in 30 days over 90 days
The EQ-5D-5L questionnaire is a preference-based measure of HRQL with one question for each of five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The responses provided allow for 243 unique health states or can be converted into EQ-5D indices and utility scores anchored at 0 for death and 1 for perfect health. The EQ-5D questionnaire also includes a Visual Analog Scale (VAS), by which respondents can report their perceived health status with a score ranging from 0 (the worst possible health state) to 100 (the best possible health state).
次要结局
- Clinical Management: The COPD Assessment Test™ (CAT) is a specific questionnaire for COPD that assesses the impact of disease symptoms on quality of life factors in chronic obstructive pulmonary disease.(Change from baseline in 30 days over 90 days)
- Changes related to quality of life factors in interstitial lung disease - King's Brief Interstitial Lung Disease (K-BILD)(Change from baseline in 30 days over 90 days)
- Change in psychosocial symptoms(Change from baseline in 30 days over 90 days)
- Change in dyspnea(Change from baseline in 30 days over 90 days)