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Feasibility, of Tele-rehabilitation Following COVID-19

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ClinicalTrials.gov Identifier: NCT04511962
Recruitment Status : Not yet recruiting
First Posted : August 13, 2020
Last Update Posted : August 13, 2020
Sponsor:
Information provided by (Responsible Party):
Hull University Teaching Hospitals NHS Trust

Brief Summary:

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.

Condition or disease Intervention/treatment
Pulmonary Disease Other: Tele-Pulmonary rehabilitation

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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: A Feasibility, Randomised Controlled Trial of Tele-rehabilitation Following COVID-19
Estimated Study Start Date : August 12, 2020
Estimated Primary Completion Date : November 25, 2021
Estimated Study Completion Date : January 20, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation

Group/Cohort Intervention/treatment
Fast track group
Participants randomised to the fast track group will receive the pulmonary rehabilitation intervention 14 ± 7 days after randomisation.
Other: Tele-Pulmonary rehabilitation
The tele-rehabilitation programme will be delivered via an NHSX / NHS Digital approved commercial video conferencing application. It will comprise an initial assessment followed by 12 bespoke classes delivered by video link over a 6 week period. Participants will be advised to undertake exercises on 5 days each week.

Wait list group
Participants randomised to the wait-list group will receive the pulmonary rehabilitation intervention 56 ± 7 days after randomisation.
Other: Tele-Pulmonary rehabilitation
The tele-rehabilitation programme will be delivered via an NHSX / NHS Digital approved commercial video conferencing application. It will comprise an initial assessment followed by 12 bespoke classes delivered by video link over a 6 week period. Participants will be advised to undertake exercises on 5 days each week.




Primary Outcome Measures :
  1. Recruitment - contact to consent ratio [ Time Frame: 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.

  2. Recruitment - screen failure rate [ Time Frame: through study completion an average of a year ]
    The proportion of patients consented to the study that do not meet the eligibility criteria

  3. Recruitment rate [ Time Frame: through study completion an average of a year ]
    The number patients recruited over the designated time frame

  4. Recruitment retention [ Time Frame: through study completion an average of 16 months ]
    The proportion of consented patients that complete the study


Secondary Outcome Measures :
  1. The Modified Medical Research Council (MMRC) Dyspnoea Scale [ Time Frame: 8 weeks ]
    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.

  2. Numerical Rating Scale (NRS) of breathlessness [ Time Frame: 8 weeks ]
    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

  3. Cough Visual analogue Scale (VAS) [ Time Frame: 8 weeks ]
    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

  4. EQ-5D-5L questionnaire [ Time Frame: 8 weeks ]
    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

  5. Hospital Anxiety and Depression scale [ Time Frame: 8 weeks ]
    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

  6. Sit to stand test [ Time Frame: 8 weeks ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients will be identified from those patients being contacted post hospitalisation at Hull University Teaching Hospitals NHS Trust due to Covid-19. Patients selected will be those still reporting breathlessness, fatigue, cough and limited activity.
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04511962


Contacts
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Contact: Michael Crooks, MRCP/MD +441482624067 m.crooks@hull.ac.uk
Contact: Angela Green, PhD 01482 605291 Angela.green28@nhs.net

Locations
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United Kingdom
Castle Hill Hospital
Cottingham, East Yorkshire, United Kingdom, HU16 5JQ
Contact: Caroline e Wright, BSc    01482 61800    c.e.wright@hull.ac.uk   
Contact: Michael f Crooks, MRCP    +441482624067    m.crooks@hull.ac.uk   
Principal Investigator: Michael Crooks, MRCP         
Sponsors and Collaborators
Hull University Teaching Hospitals NHS Trust
Publications:

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Responsible Party: Hull University Teaching Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT04511962    
Other Study ID Numbers: 285205
First Posted: August 13, 2020    Key Record Dates
Last Update Posted: August 13, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hull University Teaching Hospitals NHS Trust:
rehabilitation, covid19
Additional relevant MeSH terms:
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Lung Diseases
Respiratory Tract Diseases