Clinical trial NCT05787366: Effect of a Health Pathway for People With Persistent Symptoms Covid-19
Official title: Effect of a Health Pathway for People With Persistent Symptoms Covid-19
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: COVID-19
Keywords: health pathway
quality of life
personalized multifactorial intervention
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2023-03-28
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, multicenter, controlled, randomized open-labelled study
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: the evolution of the quality of life
timeFrame: at the end of the 6-month follow-up
Secondary outcomes:
measure: impact on quality of life
timeFrame: at 3 months
measure: impact on frailty
timeFrame: at 3 and 6 months
measure: impact on comorbidities
timeFrame: at 3 and 6 months
measure: impact on dyspnea symptoms
timeFrame: at 3 and 6 months
measure: impact on hyperventilation symptoms
timeFrame: at 3 and 6 months
measure: impact on fatigue symptoms
timeFrame: at 3 and 6 months
measure: impact on neuropathic pain symptoms
timeFrame: at 3 and 6 months
measure: impact on cognitive impairment symptoms
timeFrame: at 3 and 6 months
measure: impact on musculoskeletal disorders symptoms
timeFrame: at 3 and 6 months
measure: impact on post-exertional malaise
timeFrame: at 3 and 6 months
measure: impact on anxiety and drepssion
timeFrame: at 3 and 6 months
Other outcomes:
measure: obstacles and levers to participation and adherence to the intervention, as well as the satisfaction of patients and professionals
timeFrame: at 3 and 6 months
measure: Effectivness of the intervention
timeFrame: at 6 months
Locations:
city: Lyon
country: France
facility: Urps Medecins Libéraux Auvergne-Rhône-Alpes
city: Saint Etienne
country: France
facility: Chu Saint-Etienne
city: Saint-Étienne
country: France
facility: DAC Loire
Study officials:
affiliation: CHU de Saint Etienne
name: Frédéric ROCHE, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Jean Monnet University
name: Bienvenu BONGUE, phD
role: STUDY_DIRECTOR
References: