A Feasibility, Randomised Controlled Trial of Tele-rehabilitation Following COVID-19
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Recruitment - screen failure rate
研究概览
简要总结
Since initial reports of a novel coronavirus emerged from Hubei province, China, the world has been engulfed by a pandemic with over 3 million cases and 225,000 deaths by 30th April 2020. Health care systems around the world have struggled to cope with the number of patients presenting with COVID-19 (the disease caused by the SARS-CoV-2 virus). Although the majority of people infected with the virus have a mild disease, around 20% experience a more severe illness leading to hospital admission and sometimes require treatment in intensive care. People that survive severe COVID-19 are likely to have persistent health problems that would benefit from rehabilitation.
Pulmonary rehabilitation (PR) is a multidisciplinary program which is designed to improve physical and social performance and is typically provided for people with chronic lung conditions. PR courses typically last 6-12 weeks with patients attending classes once or twice weekly and consist of exercise and education components. PR is known to improve symptoms (e.g. breathlessness), quality of life and ability to exercise in those with lung conditions. Breathlessness is a very common symptom reported by people presenting to hospital with COVID-19 and loss of physical fitness will be very common. Using existing pulmonary rehabilitation programmes as a model, we have developed a tele-rehabilitation programme (a programme that will be delivered using video link to overcome the challenges faced by social distancing and shielding advice) for people that have been critically ill with COVID-19. In order to prove whether people benefit from this tele-rehabilitation programme after being admitted to hospital following COVID-19 we would need to perform a large clinical trial. However, before doing this it is important for us to answer some key questions:
- How many people that have been admitted to hospital and needed intensive care treatment for COVID-19 still report breathlessness, fatigue, cough and limitation of activities after being discharged from hospital?
- Is it possible to recruit these people to a trial of tele-rehabilitation after hospital discharge?
- Are people willing and able to perform tele-rehabilitation in their own home using video-link to connect with their therapist?
- Are there other rehabilitation needs that are commonly encountered by people requiring intensive care treatment for COVID-19 that could be addressed by tele-rehabilitation that the programme doesn't currently address? Investigators will perform a small study called a feasibility trial to answer these questions and gather some early information about possible benefits of tele-rehabilitation. Based on our understanding of other similar diseases, doctors and therapists think that people will benefit from rehabilitation after COVID-19. The investigators therefore want to test a trial design that makes sure that everyone gets the treatment. This type of trial is called a feasibility, wait-list design randomised controlled trial. People with breathlessness and some limitation of activities will be selected at random to receive tele-rehabilitation within 2 weeks or to wait 6-8 weeks before starting. how many people were eligible to take part, how many agreed to take part and the symptoms and rehabilitation needs that they have will be assessed. Investigators will then monitor symptoms and ability to exercise at the start and end of the trial and before and after tele-rehabilitation.
详细描述
STUDY AIMS AND OBJECTIVES Aim: To address the uncertainties relating to the design and conduct of a tele-rehabilitation programme and substantive phase 3 randomised controlled trial to evaluate its effectiveness for people that have been hospitalised with COVID-19 and required additional respiratory support (non-invasive and / or invasive ventilation).
Objectives: Specific study objectives will address uncertainties in four areas.
- Recruitment: To identify contact:consent ratio, screen failure rate, recruitment and participant retention rate. This will inform the number of sites needed to enrol sufficient participants within an acceptable timeline.
- Intervention: To assess the acceptability and fidelity of the intervention by measuring adherence in delivery and uptake. Identify additional rehabilitation needs that are not addressed by the tele-rehabilitation programme.
- Data quality: To assess the amount and pattern of missing data for study measures. Data variability across the range of outcome measures will also be assessed. These findings will inform the choice of primary and secondary outcomes for a definitive trial.
- Outcome: To assess the best primary outcome and agree other study measures for a definitive trial by identifying i) data completion (objective 3), ii) data variability for potential primary outcome measures to inform sample size calculation for the definitive trial.
In addition to the above feasibility study objectives changes in symptoms, quality of life and measures of functional capacity over time to provide preliminary insights into the natural history of recovery post COVID-19 and potential effect of tele-rehabilitation will be explored.
. STUDY DESIGN Single centre, fast-track (wait-list), randomised controlled feasibility trial of tele-rehabilitation for patients that have been hospitalised with COVID-19 and required non-invasive and/or invasive mechanical ventilation. Patients will be randomised 1:1 to fast-track or wait-list groups using random permuted blocks.
研究设计
- 研究类型
- Observational
- 观察模型
- Ecologic Or Community
- 时间视角
- Prospective
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
- •Males and females aged ≥18 years.
- •Suspected or confirmed COVID-19 requiring hospitalisation and either i) non- invasive respiratory support [CPAP, HFNO, NIV] or ii) invasive mechanical ventilation within 3 months of study recruitment.
- •> 4 weeks since hospital discharge / first positive COVID-19 swab (whichever is later) at time of screening
- •mMRC dyspnoea grades 2 or more.
- •Perceived limitation of activities compared with prior to COVID-19 hospitalisation (patient or investigators perception).
- •Internet connection and access to a device that supports video calling.
- •Able to give informed consent
排除标准
- •- 1) Significant comorbid physical or mental illness considered by the investigator to:
- •prevent engagement in modified exercise,
- •impair the participants ability to follow instructions
- •place the participant at undue risk during exercise training
- •adversely affect the recovery or rehabilitation trajectory
- •Unwilling or unable to consent or complete study measures.
- •Current involvement in other interventional clinical trials relating to COVID-19 (e.g. clinical trial of an investigational medicinal product)
结局指标
主要结局
Recruitment - screen failure rate
时间窗: through study completion an average of a year
The proportion of patients consented to the study that do not meet the eligibility criteria
Recruitment - contact to consent ratio
时间窗: through study completion an average of a year
The proportion of the total patients contacted, that meet the intieligibility criteria and give consent to take part * Data quality: completion of clinical outcomes (questionnaires and other assessments) at each time point and patterns of missing data for the study measures. * Intervention: Adherence in delivery and uptake documented in the clinical record.
Recruitment rate
时间窗: through study completion an average of a year
The number patients recruited over the designated time frame
Recruitment retention
时间窗: through study completion an average of 16 months
The proportion of consented patients that complete the study
次要结局
- The Modified Medical Research Council (MMRC) Dyspnoea Scale(8 weeks)
- Hospital Anxiety and Depression scale(8 weeks)
- Numerical Rating Scale (NRS) of breathlessness(8 weeks)
- Cough Visual analogue Scale (VAS)(8 weeks)
- EQ-5D-5L questionnaire(8 weeks)
- Sit to stand test(8 weeks)