Identifying Functional and Psycho-social Complaints After Hospitalization for SARS-CoV-2 Infection( COVID 19)- REPERCOV

COVID19 Clinical Trial

— REPERCOV  

Official title:

Identifying Functional and Psycho-social Complaints After Hospitalization for Severe SARS-CoV-2 Infection (COVID19)- REPERCOV

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04561154
• Other study ID #: CHM-2020/S10/04
• Status: Recruiting
• Phase: N/A
• Start date: June 11, 2020
• Est. completion date: June 11, 2022

Study information

• Verified date: March 2022
• Source: Centre Hospitalier le Mans
• Contact: Christelle JADEAU
• Phone: 0243434343
• Email: cjadeau[@]ch-lemans.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Since December 2019, China and then the rest of the world have been affected by the rapid spread of a new coronavirus infection called SARS-CoV-2 (severe acute respiratory syndrome coronavirus), the clinical expression of which is called Covid-19 (Coronavirus Disease 2019).

It is estimated that around 20% of symptomatic patients will be severe enough to warrant hospitalization, of which around 5% will be in intensive care.

Organ damage is multiple in Covid infection: respiratory, digestive, renal, neurological, cardiovascular due to the infection or its care. There is also a psychological and social impact of the infection or of the care that should be measured.

In this context, investigator will assess the physical and psychological complaints of patients who have presented a severe form of SARS-CoV-2 infection.

The final objective being to identify the needs to offer follow-up adapted to this emerging pathology.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 134
• Est. completion date: June 11, 2022
• Est. primary completion date: June 11, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient hospitalized for severe Covid-19 infection between March 1 and June 30, 2020 in a conventional unit, intensive care unit, at the Centre hospitalier du Mans and alive at the time of the investigation at 2 to 3 months

• Patient having given their express consent, after having received the research information letter upon discharge from hospital or having given their express consent after sending the information letter

• Age = 18 years

• Patient having contracted a SARS-CoV-2 infection proved by RT-PCR and / or retrospective serology and / or a Covid-19 syndrome with suggestive chest scanner (during the period from March 1, 2020 to June 30, 2020)

Exclusion Criteria:

• Patient opposition to participate in the cohort

• Non-French speaking patient

• Patients who cannot read or write

• Patient subject to a protective measure

• Patient not affiliated to a social security or equivalent health insurance

Related Conditions & MeSH terms

• COVID-19
• COVID19
• SARS-COV2

Intervention

Other:
• questionnaire
three months after hospitalization, a questionnaire will be sent to patients. If necessary, patient will be seen in consultation of geriatry, otorhinolaryngology, pneumology, neuropsychology

Locations

Country	Name	City	State
France	Centre Hospitalier du Mans	Le Mans

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier le Mans

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identify functionnal and psychosocial complaints	the prevalence of functional complaints and psycho-social complaints (justifying additional investigations in patients hospitalized for Covid-19 infection 3 months maximum after discharge from hospital) will be assessed by questionnaire "Modified Medical Research Council"	3 months after last hospitalization
Primary	Identify functionnal and psychosocial complaints	the prevalence of functional complaints and psycho-social complaints (justifying additional investigations in patients hospitalized for Covid-19 infection 3 months maximum after discharge from hospital) will be assessed by questionnaire "Medical Outcome Study Short Form 36 (MOS SF-36)"	3 months after last hospitalization
Primary	Identify functionnal and psychosocial complaints	the prevalence of functional complaints and psycho-social complaints (justifying additional investigations in patients hospitalized for Covid-19 infection 3 months maximum after discharge from hospital) will be assessed by FRIED criteria	3 months after last hospitalization
Primary	Identify functionnal and psychosocial complaints	the prevalence of functional complaints and psycho-social complaints (justifying additional investigations in patients hospitalized for Covid-19 infection 3 months maximum after discharge from hospital) will be assessed by questionnaire "Hospital Anxiety and Depression Scale (HADS)"	3 months after last hospitalization
Secondary	description of functionnal and psychosocial complaints	complaints will be assessed by questionnaire "Modified Medical Research Council"	3 months after last hospitalization
Secondary	description of functionnal and psychosocial complaints	complaints will be assessed by questionnaire "Medical Outcome Study Short Form 36 (MOS SF-36)"	3 months after last hospitalization
Secondary	description of functionnal and psychosocial complaints	complaints will be assessed by FRIED criteria	3 months after last hospitalization
Secondary	description of functionnal and psychosocial complaints	complaints will be assessed by questionnaire "Hospital Anxiety and Depression Scale (HADS)"	3 months after last hospitalization
Secondary	Identify the factors favoring the persistence of complaints	Risk factors are defined according to age, concomitant treatment, comorbidities before hospitalization	3 months after last hospitalization
Secondary	Describe functional, neuropsychological and social complaints at a distance	Complaints will be assessed by questionnaire"Modified Medical Research Council"	3 months after last hospitalization
Secondary	Describe functional, neuropsychological and social complaints at a distance	Complaints will be assessed by questionnaire"Medical Outcome Study Short Form 36 (MOS SF-36)"	3 months after last hospitalization
Secondary	Describe functional, neuropsychological and social complaints at a distance	Complaints will be assessed by FRIED criteria	3 months after last hospitalization
Secondary	Describe functional, neuropsychological and social complaints at a distance	Complaints will be assessed by questionnaire "Hospital Anxiety and Depression Scale (HADS)"	3 months after last hospitalization
Secondary	Describe the needs for medical and surgical consultations after discharge from hospital	Medical and surgical consultations after discharge will be measured as percentage	3 months after last hospitalization
Secondary	Describe the needs for neuropsychological support, dietetics, social assistance after discharge from hospital.	neuropsychological support, dietetics, social assistance after discharge will be measured as percentage	3 months after last hospitalization
Secondary	Describe the factors of inequalities in access to care	Describe the factors of inequalities in access to care and study their impact on the occurrence of a SARS-CoV-2 infection, its severity and the occurrence of a functional or psycho-social complaint.	3 months after last hospitalization