Mobile Application for Monitoring Patients With Home Oxygen. A Protocol of a Randomized and Controlled Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Recognition of self-management of dyspnea and through the mobile app.
研究概览
简要总结
The use of mobile technology has become part of the reality capable of changing the health services' paradigm. As a proof of that, nowadays, technology is seemed as a key tool in processes such as: data collection, epidemiological surveillance, health promotion, and disease prevention. Therefore, technological tools should be taken as an advantage to optimize the control or monitoring of patients with chronic diseases including those who require the use of home oxygen therapy.
Objective: Determine the efficiency of a mobile application for clinical monitoring of patients who require home oxygen therapy.
Methods A randomized-controlled clinical trial including individuals whose age is 18 years or older who have been diagnosed with Chronic Obstructive Pulmonary Disease (COPD) under treatment with home oxygen therapy. The sample will be divided in two groups: the intervention group will be made up of those who are followed up with the mobile app, and the control group will be made up of the patients who are followed up conventionally (regular visit of the respiratory caregiver). To measure the effect of the intervention, some outcomes variables will be taken as the recognition of self-management of dyspnea, number of exacerbations associated with oxygen therapy, and the frequency of underutilization of oxygen supplies.
详细描述
The Continuous Home Oxygen-therapy (abbreviated as OCD in Spanish) refers to the supply of oxygen for continuous, general, and/or indefinite use at the home of patients with chronic hypoxemia. The purpose of this treatment is to prolong the life of the hypoxemic patient, improve exercise tolerance, and control clinical deterioration due to low oxygen saturation.
Contextualizing the use of home oxygen in Colombia, it was observed that there was an increase in the prevalence of COPD (Chronic Obstructive Pulmonary Disease) as well as the prescription of home oxygen in the first phases of the treatment. It was found that 3.176 patients were enrolled in the home care program without knowing their sociodemographic and epidemiological characteristics. The reason behind is that there are few epidemiological studies that refer to this therapy. However, Gonzales M. et al. emphasize that current indications should be reviewed and research carried out in order to determine guidelines for recommending home oxygen in patients with COPD.
Methods / Design Study Design A randomized controlled clinical trial divided in two parallel groups with a 3-months duration will be performed in order to evaluate the efficiency of a mobile application used for the monitoring of patients with home oxygen. The control group will be made up of individuals with oxygen therapy undergoing regular monitoring (periodic visits by the respiratory caregiver), and the intervention group formed by those who have conventional monitoring with the use of the mobile app called AppO2.
Sample's size calculation A total of 32 individuals (16 for the experimental group and 16 for the control one) would be necessary to recruit, for a 1:1 ratio, a power of 80% (beta error = 20%), a certainty of 95% (alpha error = 5%) and assuming that the intervention in the experimental group will cause a 3% increase with a ±6 standard deviation in recognition of self-management of dyspnea. A final size of 44 individuals has been established (22 for the EG and 22 for the CG) to minimise the effect of possible losses in statistical power.
Intervention:
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals of 18 years of age and older
- •Patient with PaO2 <60 mmHg, SO2 <89% and dyspnea. Patients with home oxygen therapy enrolled in-home care programs during the study period.
- •Time of evolution of the disease greater to one year
- •Patients who express their willingness to participate in the study through their informed consent.
排除标准
- •Patients with the following exceptional situations will be excluded from the study:
- •Patients with invasive and/or non-invasive mechanical ventilation
- •Patients with the inability to operate a mobile application or those who do not have a smartphone with an operating system (Android or iOS) and available data connection.
结局指标
主要结局
Recognition of self-management of dyspnea and through the mobile app.
时间窗: up to 12 weeks
The Borg scale is a visual analogue scale standardised and validated . It is quick and easy to apply, allowing a graphical evaluation of the subjective perception of respiratory distress by the same patient. It has been used since the 1970s and has a range from 0 to 10. The scale determines dyspnea intensity and has a written expression added to the number, which helps categorise dyspnea's sensation in the individual being tested. The result is recorded and encoded. The interval between the ranges of the scale increases progressively, and the number 10 shows the greatest perception of dyspnea. The maximum point indicates that the severity of the disease has increased even above 10.
Saint George questionnaire for the assessment of health-related quality of life
时间窗: up to 6 weeks
It consists of 50 items divided into three scales: symptoms, activity, and impact. The items on the symptom scale refer to the frequency and severity of respiratory symptoms. The items on the activity scale assess the limitation of the activities due to dyspnea. In the impact scale, the psychological and social functional disorders produced by the disease are assessed. The items are formulated in two different ways: in the form of a question with five multiple choices/answers in which just one can be selected, and in the form of a sentence with two options: yes/no. The questionnaire is preferably self-administered, although it is also accepted through a personal interview. The average completion time is 10 minutes. The score is calculated for each of the questionnaire scales, and there is also an overall score. The range of all is from 0 (without altering the quality of life) until 100 (maximum alteration of life quality).
次要结局
未报告次要终点
研究者
Anisbed Naranjo Rojas
Respiratory therapist - Magister
ToDoMed