Rehabilitation Needs and Functional Recovery in Covid-19 Acute and Post-acute Care

NCT04456036 | Unknown DMC

• 1 other identifier: NeuroRehabAN_Covid_2020
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to apply a prospective observational design to describe the emerging functional impairments of subjects affected by COVID-19 in the acute phase and monitor their course and impact on activities and participation up to 12 months of onset. The ultimate goal is to provide a reliable framework to plan rehabilitation delivery to COVID-19 survivors in each phase and foresee health needs in the medium and long term. The secondary objective of the study is to find predictors of functional recovery, among pre-existing and emerging individual and contextual factors, with a special focus on the latency of rehabilitation start after hospital admission.

Conditions

COVID-19

Keywords

COVID-19; Rehabilitation; Recovery of Function; Activities of Daily Living; Prognosis; Quality of Life; Continuity of Patient Care

Outcome Measures

Primary Outcomes (3)

• Change from pre-COVID-19 condition in ADL independence on the mod. Rankin scale score at the enrolment (T0) assessment, at 3, 6 and 12 months

  mod. Rankin scale is a rapid and validated measure of global independence in ADL with a score ranging from 0 (no disability) to 5 (bedridden). Change= pre-COVID mod. Rankin scale score (retrospective data) - mod. Rankin scale score prospectively collected at the enrolment (T0) and at 3, 6 and 12 months

  Pre-COVID status, at enrolment and at 3, 6 12-month follow-up

• Change from pre-COVID-19 condition in walking performance on the Walking Handicap scale (WHS) at 3, 6 and 12 months

  The Walking Handicap scale is a quick and validated measure of walking performance, with a score ranging from 1 (Physiological walker: Walks for exercise only either at home or in parallel bars during physical therapy) to 6 (Community walker: Independent in all home and community activities. Can accept crowds and uneven terrain. Demonstrates complete independence in shopping centers). Change= pre-COVID WHS (retrospective data) - WHS score prospectively collected at 3, 6 and 12 months

  Pre-COVID status , and 3, 6 12-month follow-up

• Patient-reported health-related well-being perception on the 36-Item Short Form Survey - SF-36 at 3, 6 12 months follow-up

  SF-36 is a widespread validated scale assessing patient-reported changes in health-related well-being perception over the last 4 weeks

  3, 6 and 12-month follow-up

Secondary Outcomes (7)

• Change in global ADL disability on modified Barthel Index (mBI), from the enrolment (T0), at 3, 6 12 months follow-up

  the enrolment (T0) assesssment and 3, 6 and 12-month follow-up

• Change in walking capacity on Functional Ambulation Category (FAC), from the enrolment (T0) assessment, at 3, 6 12 months follow-up

  Pre-COVID status, the enrollment (T0) assessment and 3, 6 12-month follow-up

• Change in cognitive abilities on the Montreal Cognitive Assessment (MoCA) from the enrollment (T0) assessment, at 3, 6 12 months follow-up

  the enrollment (T0) assessment and 3, 6 and 12-month assessment follow-up

• Change in patient-reported pain on Numerical Rating Scale from the enrollment (T0) assessment, at 3, 6 12 months follow-up

  the enrollment (T0) and 3, 6 and 12-month assessment follow-up

• Change in swallow abilities on Dysphagia Outcome Severity Scale (DOSS) from the first functional assessment in acute care, at 3, 6 12 months follow-up

  the enrollment (T0) assessment and 3, 6 and 12-month assessment follow-up

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adults, male and female, admitted to the University Hospital "Ospedali Riuniti of Ancona" (UH-ORA) from March 1st, 2020 for the management of acute COVID-19 infection, able to provide written or oral informed consent. The only exclusion criterion will be the lack of information concerning clinical data regarding the management in the acute ward.

You may qualify if:

• age \>= 18 years,
• any gender,
• COVID-19 diagnosis: positive oro-pharyngeal swab for SARS-COV-2
• admitted to the University Hospital "Ospedali Riuniti of Ancona" (UH-ORA) from March 1st, 2020 for the management of acute COVID-19,
• able to provide written or oral informed consent.

You may not qualify if:

• the lack of information concerning clinical data regarding the management in the acute ward.

Sponsors & Collaborators

• Università Politecnica delle Marche: lead
• Maria Gabriella Ceravolo: collaborator
• Michela Coccia: collaborator
• Lauredana Ercolani: collaborator
• Elisa Andrenelli: collaborator
• Lucia Pepa: collaborator
• Rossella Cima: collaborator
• Michela Aringolo: collaborator

Study Sites (1)

Neurorehabilitation Clinic, University Hospital Ospedali Riuniti di Ancona

Ancona, 60122, Italy

RECRUITING

Related Publications (13)

• Ceravolo MG, de Sire A, Andrenelli E, Negrini F, Negrini S. Systematic rapid "living" review on rehabilitation needs due to COVID-19: update to March 31st, 2020. Eur J Phys Rehabil Med. 2020 Jun;56(3):347-353. doi: 10.23736/S1973-9087.20.06329-7. Epub 2020 Apr 22.

  PMID: 32316718 BACKGROUND

• Andrenelli E, Negrini F, de Sire A, Arienti C, Patrini M, Negrini S, Ceravolo MG; International Multiprofessional Steering Committee of Cochrane Rehabilitation REH-COVER action. Systematic rapid living review on rehabilitation needs due to COVID-19: update to May 31st, 2020. Eur J Phys Rehabil Med. 2020 Aug;56(4):508-514. doi: 10.23736/S1973-9087.20.06435-7. Epub 2020 Jun 16.

  PMID: 32539312 BACKGROUND

• de Sire A, Andrenelli E, Negrini F, Negrini S, Ceravolo MG. Systematic rapid living review on rehabilitation needs due to COVID-19: update as of April 30th, 2020. Eur J Phys Rehabil Med. 2020 Jun;56(3):354-360. doi: 10.23736/S1973-9087.20.06378-9. Epub 2020 May 15.

  PMID: 32408729 BACKGROUND

• Ahmad I, Rathore FA. Neurological manifestations and complications of COVID-19: A literature review. J Clin Neurosci. 2020 Jul;77:8-12. doi: 10.1016/j.jocn.2020.05.017. Epub 2020 May 6.

  PMID: 32409215 BACKGROUND

• Yang LL, Yang T. Pulmonary rehabilitation for patients with coronavirus disease 2019 (COVID-19). Chronic Dis Transl Med. 2020 May 14;6(2):79-86. doi: 10.1016/j.cdtm.2020.05.002. eCollection 2020 Jun.

  PMID: 32411496 BACKGROUND

• Brugliera L, Spina A, Castellazzi P, Cimino P, Arcuri P, Negro A, Houdayer E, Alemanno F, Giordani A, Mortini P, Iannaccone S. Nutritional management of COVID-19 patients in a rehabilitation unit. Eur J Clin Nutr. 2020 Jun;74(6):860-863. doi: 10.1038/s41430-020-0664-x. Epub 2020 May 20. No abstract available.

  PMID: 32433599 BACKGROUND

• Negrini S, Grabljevec K, Boldrini P, Kiekens C, Moslavac S, Zampolini M, Christodoulou N. Up to 2.2 million people experiencing disability suffer collateral damage each day of COVID-19 lockdown in Europe. Eur J Phys Rehabil Med. 2020 Jun;56(3):361-365. doi: 10.23736/S1973-9087.20.06361-3. Epub 2020 May 8.

  PMID: 32383576 BACKGROUND

• Bartolo M, Intiso D, Lentino C, Sandrini G, Paolucci S, Zampolini M; Board of the Italian Society of Neurological Rehabilitation (SIRN). Urgent Measures for the Containment of the Coronavirus (Covid-19) Epidemic in the Neurorehabilitation/Rehabilitation Departments in the Phase of Maximum Expansion of the Epidemic. Front Neurol. 2020 Apr 30;11:423. doi: 10.3389/fneur.2020.00423. eCollection 2020.

  PMID: 32425880 BACKGROUND

• Lew HL, Oh-Park M, Cifu DX. The War on COVID-19 Pandemic: Role of Rehabilitation Professionals and Hospitals. Am J Phys Med Rehabil. 2020 Jul;99(7):571-572. doi: 10.1097/PHM.0000000000001460.

  PMID: 32371624 BACKGROUND

• Li H, Xue Q, Xu X. Involvement of the Nervous System in SARS-CoV-2 Infection. Neurotox Res. 2020 Jun;38(1):1-7. doi: 10.1007/s12640-020-00219-8. Epub 2020 May 13.

  PMID: 32399719 BACKGROUND

• Valenzuela PL, Joyner M, Lucia A. Early mobilization in hospitalized patients with COVID-19. Ann Phys Rehabil Med. 2020 Jul;63(4):384-385. doi: 10.1016/j.rehab.2020.04.005. Epub 2020 May 18. No abstract available.

  PMID: 32418848 BACKGROUND

• Stein J, Visco CJ, Barbuto S. Rehabilitation Medicine Response to the COVID-19 Pandemic. Am J Phys Med Rehabil. 2020 Jul;99(7):573-579. doi: 10.1097/PHM.0000000000001470.

  PMID: 32433243 BACKGROUND

• Wang X, Xu H, Jiang H, Wang L, Lu C, Wei X, Liu J, Xu S. Clinical features and outcomes of discharged coronavirus disease 2019 patients: a prospective cohort study. QJM. 2020 Sep 1;113(9):657-665. doi: 10.1093/qjmed/hcaa178.

  PMID: 32442308 BACKGROUND

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Maria Gabriella Ceravolo, MD PhD

  Dep. of Experimental and Clinical Medicine - University Politecnica delle Marche

  STUDY DIRECTOR

Central Study Contacts

Marianna Capecci, MD PhD

CONTACT

+390715964043; m.capecci@univpm.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: June 30, 2020
• First Posted: July 2, 2020
• Study Start: July 1, 2020
• Primary Completion: December 31, 2020
• Study Completion: June 30, 2021
• Last Updated: April 27, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)