PEP Flute-selfcare to Prevent Respiratory Deterioration and Hospitalization Among COVID-19 Patients: a Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 378
- 试验地点
- 2
- 主要终点
- Self-reported CAT-score (COPD Assessment Test)
研究概览
简要总结
Most research on the coronavirus SARS-CoV-2 and COVID-19 disease relate to screening measures, development of vaccines and optimising treatment of hospitalised patients. It is likely that this pandemic will be ongoing for several years until a high level of immunity is reached in the population or a vaccine has been developed. Thus, there is a need of measures to help the SARS-CoV-2 infected individual at home to overcome the course of disease with less symptoms and strain. A Positive Expiratory Pressure (PEP) flute is feasible for home use and it is possible that regular use of PEP flute may prevent the progression of respiratory symptoms in non-hospitalized individuals with COVID-19 disease.
The primary objective of the study is to examine the effect of PEP flute use among SARS-CoV-2 infected, non-hospitalized patients on self-reported change in COPD Assessment Test (CAT) score during 30 days of follow-up.
The secondary objectives are to compare the development in hospitalization rates and use of antibiotics in the intervention group and the control group during the follow-up period.
详细描述
It is hypothesized that the PEP flute has positive effects on SARS-CoV-2 infected individual's self-reported respiratory symptoms such as dyspnoea, coughing and perceived mucus clearance through beneficial effects on lung function and airway clearance. Furthermore, the investigators expect a lower rate of hospitalization and use of antibiotics in the intervention group as compared to the control group.
Finally, potential subgroup effects by gender, age, comorbidity and BMI at study entry will be explored for all outcomes.
Based upon a sample size estimation the investigators assess that inclusion of 200 participants in each intervention arm will be an adequate number. Based on the present testing strategy and COVID-19 incidence, current expectations are that two months should be enough to recruit 400 patients. The investigators will allow for recruitment to the end of December 2020, but will terminate enrolment at n = 400.
Link to detailed protocol paper will be added once published.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessors will be blinded to treatment allocation where possible. This is of outmost importance, and participants are requested not to disclose their allocation when outcomes are assessed. To test the blinding efficacy, the outcome assessors are asked what treatment strategy they think a patient has received after assessments.
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
- •Positive SARS-CoV-2
- •Symptoms of SARS-CoV-2 infection e.g. fever, cough and shortness of breath.
- •Access to use a smartphone
- •Can reply to a questionnaire (sent on email, text messages or via telephone interview) in Danish
- •Given informed consent
排除标准
- •Age < 18 years.
- •Any condition or impairment that, in the opinion of the investigator, makes a potential participant unsuitable for participation or which obstruct participation, such as psychiatric disorders.
- •Hospitalised patients or citizens living in nursing homes
结局指标
主要结局
Self-reported CAT-score (COPD Assessment Test)
时间窗: Day 30.
CAT-scores will be measured using a telephone administered questionnaire. The CAT-score is validated to evaluate symptoms in COPD patients. Eight items covers symptoms of cough, sputum, chest pain, dyspnoea, activities of daily living at home, feeling safe at home despite symptoms (modified for the present study from feeling safe at leaving home despite symptoms), sleep quality and vigour. The eight items sum up to a range of 0-40 with higher scores indicating more respiratory impairment. Although validated for COPD-use, the CAT-scale is considered useful in the present study because several of the items (dyspnoea, cough, fatigue, sputum and pleuritic chest pain) previously have been used as outcome variables in pneumonia studies. The outcome assessment can be taken within + 1 week for the scheduled visit.
次要结局
- Hospital admissions(Up to day 30, 90 and 180.)
- Use of antibiotics(Up to day 30, 90 and 180.)
- Self-reported CAT-score (COPD Assessment Test)(Day 90, Day 180.)
研究者
Berit Lilienthal Heitmann
Professor
Bispebjerg Hospital