Effect of a Health Pathway for People With Persistent Symptoms Covid-19 (SPACO+)

Centre Hospitalier Universitaire de Saint Etienne

Status: Enrolling

Conditions: COVID-19

Treatments: Other: usual care and follow-up by a nurse; Other: Personalized Multifactorial Intervention (IMP)

Study type: Interventional

Funder types: Other

Identifiers

NCT05787366

22CH550

2020-A00982-37 (Other Identifier)

Details and patient eligibility

About

People with persistent symptoms of covid-19 have increased needs for needs for management of their overall health (physical, psychological and social). Persistent covid-19 symptoms have a negative impact on quality of life. By proposing a follow-up and an intervention on the reduction of these symptoms, the symptoms, the study will improve quality of life.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Persons who have been infected with Covid-19.
• Person with persistent clinical signs of Covid-19 for more than 12 weeks, referred by one of the partner structures of the project. The persistent signs of Covid-19 are: fatigue which can be severe, neurological disorders neurological disorders (cognitive, sensory, headaches), cardio-thoracic disorders (pain and chest tightness, tachycardia, dyspnea, cough) and disorders of smell and taste. Pain, digestive disorders and skin disorders are also common.
• Person who has agreed to participate and has given informed consent to participate in the study

Exclusion Criteria:

• Refused to participate in the study
• Person under legal protection
• Person with severe cognitive impairment

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

Usual care

Other group

Description:

usual care and follow-up by a nurse: control group receiving conventional management, i.e. referral to a specialist(s) according to symptoms, as well as nursing follow-up.

Treatment:

Other: usual care and follow-up by a nurse

Intervention group

Experimental group

Description:

usual care and Personalized Multifactorial Intervention: group benefiting from the Personalized Multifactorial Intervention coordinated by a nurse

Treatment:

Other: Personalized Multifactorial Intervention (IMP)