Pulmonary Disease Clinical Trial
Official title:
A Feasibility, Randomised Controlled Trial of Tele-rehabilitation Following COVID-19
NCT number | NCT04511962 |
Other study ID # | 285205 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | August 24, 2020 |
Est. completion date | June 20, 2023 |
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.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | June 20, 2023 |
Est. primary completion date | June 30, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1) Males and females aged =18 years. - 2) 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. - 3) > 4 weeks since hospital discharge / first positive COVID-19 swab (whichever is later) at time of screening - 4) mMRC dyspnoea grades 2 or more. - 5) Perceived limitation of activities compared with prior to COVID-19 hospitalisation (patient or investigators perception). - 6) Internet connection and access to a device that supports video calling. - 7) Able to give informed consent Exclusion Criteria: - - 1) Significant comorbid physical or mental illness considered by the investigator to: - 2) prevent engagement in modified exercise, - 3) impair the participants ability to follow instructions - 4) place the participant at undue risk during exercise training - 5) 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) |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Castle Hill Hospital | Cottingham | East Yorkshire |
Lead Sponsor | Collaborator |
---|---|
Hull University Teaching Hospitals NHS Trust |
United Kingdom,
Al-shair K, Muellerova H, Yorke J, Rennard SI, Wouters EF, Hanania NA, Sharafkhaneh A, Vestbo J; ECLIPSE investigators. Examining fatigue in COPD: development, validity and reliability of a modified version of FACIT-F scale. Health Qual Life Outcomes. 2012 Aug 23;10:100. doi: 10.1186/1477-7525-10-100. — View Citation
Booth S, Galbraith S, Ryan R, Parker RA, Johnson M. The importance of the feasibility study: Lessons from a study of the hand-held fan used to relieve dyspnea in people who are breathless at rest. Palliat Med. 2016 May;30(5):504-9. doi: 10.1177/0269216315607180. Epub 2015 Oct 22. — View Citation
Caraceni A. Evaluation and assessment of cancer pain and cancer pain treatment. Acta Anaesthesiol Scand. 2001 Oct;45(9):1067-75. doi: 10.1034/j.1399-6576.2001.450903.x. — View Citation
Dorman S, Jolley C, Abernethy A, Currow D, Johnson M, Farquhar M, Griffiths G, Peel T, Moosavi S, Byrne A, Wilcock A, Alloway L, Bausewein C, Higginson I, Booth S. Researching breathlessness in palliative care: consensus statement of the National Cancer Research Institute Palliative Care Breathlessness Subgroup. Palliat Med. 2009 Apr;23(3):213-27. doi: 10.1177/0269216309102520. Epub 2009 Feb 27. — View Citation
Farquhar MC, Prevost AT, McCrone P, Brafman-Price B, Bentley A, Higginson IJ, Todd C, Booth S. Is a specialist breathlessness service more effective and cost-effective for patients with advanced cancer and their carers than standard care? Findings of a mixed-method randomised controlled trial. BMC Med. 2014 Oct 31;12:194. doi: 10.1186/s12916-014-0194-2. — View Citation
Gift AG, Narsavage G. Validity of the numeric rating scale as a measure of dyspnea. Am J Crit Care. 1998 May;7(3):200-4. — View Citation
Gross MM, Stevenson PJ, Charette SL, Pyka G, Marcus R. Effect of muscle strength and movement speed on the biomechanics of rising from a chair in healthy elderly and young women. Gait Posture. 1998 Dec 1;8(3):175-185. doi: 10.1016/s0966-6362(98)00033-2. — View Citation
Ozalevli S, Ozden A, Itil O, Akkoclu A. Comparison of the Sit-to-Stand Test with 6 min walk test in patients with chronic obstructive pulmonary disease. Respir Med. 2007 Feb;101(2):286-93. doi: 10.1016/j.rmed.2006.05.007. Epub 2006 Jun 27. — View Citation
Powers J, Bennett SJ. Measurement of dyspnea in patients treated with mechanical ventilation. Am J Crit Care. 1999 Jul;8(4):254-61. — View Citation
Wade J, Mendonca S, Booth S, Ewing G, Gardener AC, Farquhar M. Are within-person Numerical Rating Scale (NRS) ratings of breathlessness 'on average' valid in advanced disease for patients and for patients' informal carers? BMJ Open Respir Res. 2017 Oct 11;4(1):e000235. doi: 10.1136/bmjresp-2017-000235. eCollection 2017. — View Citation
Wilcock A, Crosby V, Clarke D, Tattersfield A. Repeatability of breathlessness measurements in cancer patients. Thorax. 1999 Apr;54(4):375. doi: 10.1136/thx.54.4.374b. No abstract available. — View Citation
Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Recruitment - contact to consent ratio | 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. |
through study completion an average of a year | |
Primary | Recruitment - screen failure rate | The proportion of patients consented to the study that do not meet the eligibility criteria | through study completion an average of a year | |
Primary | Recruitment rate | The number patients recruited over the designated time frame | through study completion an average of a year | |
Primary | Recruitment retention | The proportion of consented patients that complete the study | through study completion an average of 16 months | |
Secondary | The Modified Medical Research Council (MMRC) Dyspnoea Scale | The Modified Medical Research Council Dyspnoea Scale is a self rating tool to measure the degree of disability that breathlessness poses on day to day activities on a scale of 0-4; the higher the score the worse the outcome. A comparison of Change in MMRC dyspnoea scale from baseline to post 8 weeks tele rehab within the group and between fast track and wait list group. | 8 weeks | |
Secondary | Numerical Rating Scale (NRS) of breathlessness | The Numerical Rating Scale is a self rating tool to measure breathlessness on a 0-10 scale; a higher number indicates a worse outcome. A comparison of change in numerical scale from baseline to post 8 weeks tele rehab within the group and between fast track and wait list group | 8 weeks | |
Secondary | Cough Visual analogue Scale (VAS) | The Cough Visual Analogue Scale is a self rating assessment of cough on an 0-100mm scale: the higher the number reported the worse the symptom. A comparison of Change in cough visual analogue scale from baseline to post 8 weeks tele rehab within the group and between fast track and wait list group | 8 weeks | |
Secondary | EQ-5D-5L questionnaire | The EQ-5D-5L questionnaire assesses the patients current health status and consists of two elements: 1. Visual Analogue Scale with a range of 0-100mm- the higher the number the worse the outcome 2. A quality of life questionnaire split into 5 domains which generates a 5 digit code ranging from 11111 to 55555 with the higher number indicating a worse outcome. A comparison of Change in EQ-5D-5L quality of life questionnaire from baseline to post 8 weeks tele rehab within the group and between fast track and wait list group | 8 weeks | |
Secondary | Hospital Anxiety and Depression scale | The Hospital Anxiety and Depression scale consists of two sub scales anxiety and depression with a range of between 0-21, the higher score indicating the worse outcome. A comparison of Change in Hospital anxiety and depression questionnaire from baseline to post 8 weeks tele rehab within the group and between fast track and wait list group | 8 weeks | |
Secondary | Sit to stand test | comparison of sit to stand test from baseline to post 8 weeks tele rehab within the group and between fast track and wait list grou | 8 weeks |
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