COVID-19 trials registries data warehouse

https://www.isrctn.com/ISRCTN11466448

Sharisse Alleyne

regain@warwick.ac.uk

2020-11-23

Recruiting

RCT

Randomized

Parallel

Open label

multi-center

Long covid

Current inclusion criteria as of 19/03/2021: 1. UK resident 2. Aged =18 years 3. = 3 months after any UK hospital discharge related to COVID-19 infection, regardless of need for critical care or ventilatory support 4. Substantial, as defined by the participant, COVID-19 related physical and/or mental health problems 5. Access to, and ability/support to use, email, text message, internet video, including webcam and audio 6. Ability to provide informed consent 7. Able to understand spoken and written English or Bengali, Gujarati, Urdu, Punjabi, Mandarin themselves or with support from family/friends Previous inclusion criteria: 1. Aged =18 years 2. =3 months after any hospital discharge related to COVID-19 infection, regardless of need for critical care or ventilatory support 3. Substantial, as defined by the participant, COVID-19 related physical and/or mental health problems 4. Access to, and ability/support to use email, text message, internet video, including webcam and audio 5. Ability to provide informed consent 6. Able to understand spoken and written English or Bengali, Gujarati, Urdu, Punjabi, Mandarin themselves or with support from family/friends

1. Exercise contraindicated 2. Severe mental health problems preventing engagement 3. Previous randomisation in the present trial 4. Patient already engaging in, or planning to engage in a conflicting NHS delivered rehabilitation programme in the next 12 weeks 5. A member of the same household has previously been randomised in the present trial

2

University Hospitals Coventry and Warwickshire NHS Trust

18

100

United Kingdom

Patients recovered from covid

N/A

535

Health-related quality of life (HRQoL) measured using the PROMIS® 29+2 Profile v2.1 (PROPr) at 3 months post-randomisation

Not reported

[{"arm_notes": "", "treatment_id": 583, "treatment_name": "Home based rehabilitation program", "treatment_type": "Rehabilitation", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]