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

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ClinicalTrials.gov Identifier: NCT04456036
Recruitment Status : Recruiting
First Posted : July 2, 2020
Last Update Posted : April 27, 2021
Sponsor:
Collaborators:
Maria Gabriella Ceravolo
Michela Coccia
Lauredana Ercolani
Elisa Andrenelli
Lucia Pepa
Rossella Cima
Michela Aringolo
Information provided by (Responsible Party):
Marianna Capecci, PhD, Università Politecnica delle Marche

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.

Condition or disease
COVID-19

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Official Title: Rehabilitation Needs and Functional Recovery in Covid-19 Acute and Post-acute Care: Study of Functional Evolution, Predictors of Activities and Participation Recovery After Severe Covid-19 and Rehabilitation Role
Actual Study Start Date : July 1, 2020
Actual Primary Completion Date : December 31, 2020
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rehabilitation




Primary Outcome Measures :
  1. 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 [ Time Frame: Pre-COVID status, at enrolment and at 3, 6 12-month follow-up ]

    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


  2. Change from pre-COVID-19 condition in walking performance on the Walking Handicap scale (WHS) at 3, 6 and 12 months [ Time Frame: Pre-COVID status , and 3, 6 12-month follow-up ]

    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


  3. Patient-reported health-related well-being perception on the 36-Item Short Form Survey - SF-36 at 3, 6 12 months follow-up [ Time Frame: 3, 6 and 12-month follow-up ]
    SF-36 is a widespread validated scale assessing patient-reported changes in health-related well-being perception over the last 4 weeks


Secondary Outcome Measures :
  1. Change in global ADL disability on modified Barthel Index (mBI), from the enrolment (T0), at 3, 6 12 months follow-up [ Time Frame: the enrolment (T0) assesssment and 3, 6 and 12-month follow-up ]

    The mBI is a validated measure of physical disability widely used to assess individual behavior in activities of daily living for patients with disabling conditions. It measures what patients do in practice. Score assignment can be made without any previous formal training.

    Change = mBI score at the enrolment (T0) assessment - mBI score at 3, 6 and 12-month follow-up


  2. Change in walking capacity on Functional Ambulation Category (FAC), from the enrolment (T0) assessment, at 3, 6 12 months follow-up [ Time Frame: Pre-COVID status, the enrollment (T0) assessment and 3, 6 12-month follow-up ]

    FAC is a validated measures of gait capacity with a score ranging from 0 (unable to walk) to 5 (able to walk independently in any environment)

    Change= pre-COVID FAC score (retrospective data) - FAC score prospectively collected at the enrolment (T0) assessment and at 3, 6 and 12 months


  3. Change in cognitive abilities on the Montreal Cognitive Assessment (MoCA) from the enrollment (T0) assessment, at 3, 6 12 months follow-up [ Time Frame: the enrollment (T0) assessment and 3, 6 and 12-month assessment follow-up ]

    The MoCA is a cognitive screening test designed to assist health professionals in the detection of mild cognitive impairment. It is especially sensitive at detecting dysfunctions in executive strategies.

    Change = MoCA score at the enrollment (T0) - MoCA score at 3, 6 and 12-month follow-up


  4. Change in patient-reported pain on Numerical Rating Scale from the enrollment (T0) assessment, at 3, 6 12 months follow-up [ Time Frame: the enrollment (T0) and 3, 6 and 12-month assessment follow-up ]

    Pain NRS is a widespread validate assessment tool measuring pain perception with a score ranging from 0 (no pain), to 10 (worst ever pain).

    Change= NRS score at the enrollment (T0) assessment - NRS score at 3, 6 and 12-month follow-up


  5. 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 [ Time Frame: the enrollment (T0) assessment and 3, 6 and 12-month assessment follow-up ]

    DOSS is a simple, easy-to-use, 7-point scale developed to systematically rate the functional severity of dysphagia based on objective assessment, with a score ranging from 1 (severe dysphagia: Non Per oral nutrition) to 7 ( Full per oral nutrition).

    Change= DOSS score at enrolment (T0) - DOSS score at 3, 6 and 12-month follow-up


  6. Change in endurance on 6-Minutes Walking Test (6MWT) from the enrolment (T0) assessment, at 3, 6 12 months follow-up [ Time Frame: the enrolment (T0) and 3, 6 and 12-month assessment follow-up ]

    6MWT is a validated and synthetic measure of endurance influenced by cardio-respiratory and motor function impairment.

    Change = 6MWT on enrolment (T0) - 6MWT score at 3, 6 and 12-month follow-up


  7. Change in mood status on Beck Depression Inventory (BDI) from the enrolment (T0) assessment, at 3, 6 and 12 month follow-up [ Time Frame: enrolment (T0) assessment and 3, 6 and 12-month assessment follow-up ]

    The BDI is a 21-question multiple-choice self-report inventory, one of the most widely used psychometric tests for measuring the severity of depression.

    Change = BDI on enrolment (T0) assessment - BDI score at 3, 6 and 12-month follow-up




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:   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.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

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): NCT04456036


Contacts
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Contact: Marianna Capecci, MD PhD +390715964043 m.capecci@univpm.it

Locations
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Italy
Neurorehabilitation Clinic, University Hospital Ospedali Riuniti di Ancona Recruiting
Ancona, Italy, 60122
Contact: Marianna Capecci, Prof    0715964043    m.capecci@univpm.it   
Principal Investigator: Marianna Capecci, Prof         
Sub-Investigator: Michela Coccia, Dr         
Sub-Investigator: Lauredana Ercolani, Dr         
Sub-Investigator: Michela Aringolo, Dr         
Sub-Investigator: Elisa Andrenelli, Dr         
Sub-Investigator: Lucia Pepa, Dr         
Sub-Investigator: Rossella Cima, Dr         
Sub-Investigator: Maria Gabriella Ceravolo, Prof         
Sponsors and Collaborators
Università Politecnica delle Marche
Maria Gabriella Ceravolo
Michela Coccia
Lauredana Ercolani
Elisa Andrenelli
Lucia Pepa
Rossella Cima
Michela Aringolo
Investigators
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Study Director: Maria Gabriella Ceravolo, MD PhD Dep. of Experimental and Clinical Medicine - University Politecnica delle Marche
Publications:

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Responsible Party: Marianna Capecci, PhD, Prof, Università Politecnica delle Marche
ClinicalTrials.gov Identifier: NCT04456036    
Other Study ID Numbers: NeuroRehabAN_Covid_2020
First Posted: July 2, 2020    Key Record Dates
Last Update Posted: April 27, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The research results will be made available through indexed Journals as scientific publication.

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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 Marianna Capecci, PhD, Università Politecnica delle Marche:
COVID-19
Rehabilitation
Recovery of Function
Activities of Daily Living
Prognosis
Quality of Life
Continuity of Patient Care
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases