key: cord-0989988-yhmvo9hj authors: Swarnakar, R.; Yadav, S. L.; V, S.; Soni, K. D.; Aggrawal, R.; Trikha, A. title: ReCOVer study: A Cross-sectional Observational Study to Identify the Rehabilitation Need in Post-discharge COVID-19 Survivors date: 2021-04-22 journal: nan DOI: 10.1101/2021.04.19.21255750 sha: a14252ac7d6a73efa7da13c1436ea3862648261a doc_id: 989988 cord_uid: yhmvo9hj Introduction: With the increasing number of Coronavirus disease-2019 (COVID-19) cases there is a simultaneous increase in recovered cases too. There are many post-covid complications where the need for rehabilitation intervention is very conspicuous especially pulmonary, neurological complications. Hence data are of utmost importance to find out those rehabilitation needs among post-covid survivors. Methods and analysis: ReCOVer (Rehabilitation Need in Post-discharge COVID-19 Survivors), a cross-sectional observational study protocol has been planned to find out rehab-need by assessing the International Classification of Functioning, Disability, and Health (ICF) core data set, COVID-19 Yorkshire Rehab Screen (C19-YRS) tool, The Post-COVID-19 Functional Status (PCFS) scale, barriers to functional independence and rehab services (affordability & availability). Post-discharge (minimum 1 week) Covid patients (required hospitalization) will be included in the study. The study will be conducted through the Telerehabilitation facility. The study will conform to the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines. Ethics and dissemination: The study received ethical approval from the Institute Ethics Committee, All India Institute of Medical Sciences (AIIMS), New Delhi, India. Findings will be disseminated at scientific conferences/meetings, peer-reviewed journals, and to relevant stakeholders including the ministry of health (if required). Worldwide coronavirus disease (COVID-19) has affected 14 million and more than 8 million people have recovered from this disease. 1 In India, confirmed cases crossed 11 lakhs and recovered cases crossed 7 lakhs. 2 In the view of multiple post-COVID complications especially neurological and cardiopulmonary etc, rehabilitation need is very conspicuous. But currently evidence from literature and studies are lacking on rehabilitation of COVID-19 population. There is no study addressing rehab need in different subgroups of COVID-19 especially among different clinical severity of COVID-19 after discharge. At this current scenario we propose to assess the need of rehabilitation in different clinical severity of COVID-19 patients after discharge from hospitalisation. This would form a basis for rehab recommendations for these patients and also it would help to address the knowledge gaps and to gather observations for future research. treat all likely pathogens causing SARI and sepsis as soon as possible, within 1 hour of initial assessment for patients with sepsis. Recognize severe hypoxemic respiratory failure when a patient with respiratory distress is failing to respond to standard oxygen therapy and prepare to provide advanced oxygen/ventilatory support. Implement mechanical ventilation using lower tidal volumes (4-8 mL/kg predicted body weight, PBW) and lower inspiratory pressures (plateau pressure < 30 cmH2O). In adult patients with severe ARDS, prone ventilation for 12-16 hours per day is recommended. Septic shock: Recognize septic shock in adults when infection is suspected or confirmed AND vasopressors are needed to maintain mean arterial pressure (MAP) ≥ 65 mmHg AND lactate is ≥ 2 mmol/L, in absence of hypovolemia. Recognize septic shock in children with any hypotension (systolic blood pressure [SBP] < 5th centile or > 2 SD below normal for age) or two or more of the following: altered mental state; bradycardia or tachycardia (HR < 90 bpm or > 160 bpm in infants and HR < 70 bpm or > 150 bpm in children); prolonged capillary refill (> 2 sec) or feeble pulses; tachypnoea; mottled or cold skin or petechial or purpuric rash; increased lactate; oliguria; hyperthermia or hypothermia. The most common clinical features were fever (99%), fatigue (70%), dry cough (59%), anorexia (40%), myalgias (40%), dyspnea (31%), and sputum production (27%). 5 Extra-respiratory manifestations of patients with COVID-19 6 • Cardiac: Acute cardiac injury (8-12%), heart failure (23-52%), arrhythmia (8.9-16.7%), shock, acute myocarditis, chest tightness. It has been suggested that viral invasion of the central nervous system by SARS-CoV2 is possible by the synapse-connected route observed with other coronaviruses such as SARS-CoV and can lead to several neurological complications including ataxia, seizures, neuralgia, unconsciousness, acute cerebrovascular disease and encephalopathy. 7, 8 The most common peripheral manifestation is hyposmia and Hyposmia (5.1-20.4%), anosmia (79.6%), dysgeusia (8.5%), ageusia (1.7%). 9 Neuro-muscular complication as listed below: 10 Helms et al. 11 reported neurological complications in an observational case series of 58 patients admitted to the ICU for ARDS, secondary to COVID-19 in Strasbourg, France, between 3 March 2020 and 3 April 2020. Neurological findings were seen in 14% of patients at admission and 69% of cases were seen when they were weaned off sedation and paralytics. Most frequently observed symptoms were confusion (65%), agitation (69%), upper motor neuron syndrome signs like hyperreflexia with clonus and positive Babinski's sign (69%) during the ICU stay, and a dysexecutive syndrome (33%) after discharge. MRI of the brain in patients who developed unexplained encephalopathic features revealed leptomeningeal enhancement (62%), perfusion abnormalities on MRI (100%), and ischemic CVA (23%). Only one out of the eight patients who underwent electroencephalogram (EEG) showed findings consistent with encephalopathy. 87.4% recovered COVID-19 patients reported persistence of at least 1 symptom, particularly fatigue (53.1%), dyspnea (43.4%), joint pain, (27.3%) and chest pain (21.7%). 12 In India till now no studies have focussed rehabilitation in Covid. Currently rehabilitation is focussing on pulmonary rehabilitation in COVID-19 during hospital or ICU stay. Recently one consensus has been developed on post-Covid rehabilitation in UK, 13 but in different settings it could be variable. For the time being, rehab guidelines for COPD has been recommended for rehabilitation of Covid patients. Most of the studies has emphasized pulmonary component but are lacking a comprehensive rehabilitation program. There is one study is going regarding telerehabilitation in Covid patient, but studies on rehab or even tele All rights reserved. No reuse allowed without permission. (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. The copyright holder for this preprint this version posted April 22, 2021. ; https://doi.org/10.1101/2021.04.19.21255750 doi: medRxiv preprint rehab in post-Covid population are lacking. One study 14 has addressed 32 post-acute Covid patient with early rehabilitation in Italy. C19-YRS tool: 15 It is recently developed, free but not validated. It is made for rehab need assessment in post Covid-19 patients. It addresses all domain of WHO ICF. PCFS scale: 16 A recently developed scale, it covers the full spectrum of functional outcomes, and focuses on both limitations in usual duties/activities and changes in lifestyle in six scale grades. It is free to use, not validated. ICF core data set: 17 For COVID-19 there is no separate ICF data set. Hence, in our study we would include all data in accordance with ICF rehabilitation data set including subcategories of musculoskeletal, neurological, cardiopulmonary condition according to individual patient's condition as mentioned in ICF data set. Worldwide more than 8 lakhs population have been recovered from Covid-19. Post-Covid neurological, cardiovascular sequelae have been identified, moreover it affects multiple system in our body. In this context rehabilitation would be an essential component in those patients for comprehensive management. Hence, we propose this study to identify rehabilitation needs in these population for gathering information for further studies like type of rehabilitation intervention needed, to whom it would be needed, how can it be offered, its efficacy, and feasibility etc. To assess the rehabilitation-need in post-discharge COVID-19 survivors. To determine the rehabilitation-need in post-discharge COVID-19 survivors by assessing: Primary objective: ICF core data set. 1. COVID-19 Yorkshire Rehab Screen (C19-YRS) tool. • Study setting: The study will be conducted in the department of Physical Medicine and Rehabilitation (PM&R), AIIMS, New Delhi. • Study duration: The study shall commence after approval from the institutional review board and the ethical committee and will be continued for a period of one month. • Type of study: A cross-sectional observational study. Study will conform to the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines. All rights reserved. No reuse allowed without permission. (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. Patients will be explained about the whole procedure of the study. 4. Consent: Consent will be taken according to the Telemedicine Practice Guidelines, India (2020). 18 5. Participant's details and history: All demographic and clinical characteristics (age, sex, residence, source of contact of COVID-19 or contact tracing, duration of symptoms, durations of hospital admission, duration of ICU stay if any, history of diabetes, hypertension, kidney disease, cardiac disease or any other disease etc.), laboratory findings and medication history all will be collected from the ongoing cohort study (Ref. No IEC-291/17.04.2020, RP-11/2020. Code No. A-COVID-41) . 6 . Addressing current clinical complaints (if any). 7. Data collection and assessment of C19-YRS tool and PCFS scale: It will be done at single time-point (during telemedicine consultation). 8. Listing of barriers to functional independence, rehab services, hygiene practices: For each barrier, its mechanism, coping strategies will be documented. Based on these policy implications would be addressed. 9. Information/education need: Source of information or awareness regarding COVID-19, and in Yes/No format, knowledge regarding social distancing, hand hygiene, mask use will be documented. 10. Addressing support need: Time given per day, income, and source of income of caregiver will be documented. All rights reserved. No reuse allowed without permission. (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. • Interventions: Not applicable. • Data will be entered in Microsoft EXCEL spreadsheet. • Data will presented as mean ±SD/median (range, min, max) and frequency percentage. • Stata 14.1 will be used in analysis. • P value < 0.05 will be taken as statistically significant. All rights reserved. No reuse allowed without permission. (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. I'll ask some questions about how you might have been affected since your illness. If there are other ways that you've been affected then there will be a chance to let me know these at the end. On a scale of 0-10, with 0 being not breathless at all, and 10 being extremely breathless, how breathless are you: All rights reserved. No reuse allowed without permission. (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. The copyright holder for this preprint this version posted April 22, 2021. ; https://doi.org/10.1101/2021.04.19.21255750 doi: medRxiv preprint World Health Organization Website Ministry of Health and Family Welfare, Government of India Website Global Surveillance for human infection with coronavirus disease (COVID-19 World Health Organization Website. 2020. Clinical management of COVID-19 Accessed 21 Clinical characteristics of 138 hospitalized patients with 2019 novel coronavirus-infected pneumonia in Wuhan, China Extra-respiratory manifestations of COVID-19 Coronavirus disease 2019 (COVID-19) The neuroinvasive potential of SARS-CoV2 may play a role in the respiratory failure of COVID-19 patients Clinical findings in a group of patients infected with the 2019 novel coronavirus (SARS-CoV2) outside of China: retrospective case series for the Gemelli Against COVID-19 Post-Acute Care Study Group. Persistent Symptoms in Patients After Acute COVID-19 The Stanford Hall consensus statement for post-COVID-19 rehabilitation Rehabilitation and respiratory management in the acute and early post-acute phase Assessing long-term rehabilitation needs in COVID-19 survivors using a telephone screening tool (C19-YRS tool) -ACNR | Paper & The Post-COVID-19 Functional Status (PCFS) Scale: a tool to measure functional status over time after COVID-19 Telemedicine Practice Guidelines. 2020. Ministry of Health and Family Welfare, Government of India Website All rights reserved. No reuse allowed without permission. (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity Have you or your family noticed any changes to your voice such as difficulty being heard, altered quality of the voice, your voice tiring by the end of the day or an inability to alter the pitch of your voice? Yes No If Yes: rate the significance of impact on a scale of 0-10 (0 being no impact, 10 being significant impact) 0