Effect of a Health Pathway for People With Persistent Symptoms Covid-19

NCT ID: NCT05787366

Last Updated: 2025-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-15

Study Completion Date

2026-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective, multicenter, controlled, randomized open-labelled study
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Usual care

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.

Group Type OTHER

usual care and follow-up by a nurse

Intervention Type OTHER

follow-up by a nurse and referral to a specialist(s) according to symptoms

Intervention group

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

Group Type EXPERIMENTAL

Personalized Multifactorial Intervention (IMP)

Intervention Type OTHER

The content of the intervention is defined according to the result of the initial assessment in relation to the person's needs and the nature of his or her persistent symptoms. The patient, depending on his or her needs, may choose to participate in the following workshops :

* Knowledge of the disease and specific management, (led by the nurse)
* Covid-19 and anxiety/depression, (psychologist)
* Fatigue and adapted physical activities (video capsules)
* Covid-long and social link (professional and voluntary activities...) (social worker and/or nurse)
* The Recovery Café aims to provide a space for patients to listen to each other and share their experiences around themes related to the different dimensions of recovery: medical and psychological, economic, professional, social and existential.

Interventions

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usual care and follow-up by a nurse

follow-up by a nurse and referral to a specialist(s) according to symptoms

Intervention Type OTHER

Personalized Multifactorial Intervention (IMP)

The content of the intervention is defined according to the result of the initial assessment in relation to the person's needs and the nature of his or her persistent symptoms. The patient, depending on his or her needs, may choose to participate in the following workshops :

* Knowledge of the disease and specific management, (led by the nurse)
* Covid-19 and anxiety/depression, (psychologist)
* Fatigue and adapted physical activities (video capsules)
* Covid-long and social link (professional and voluntary activities...) (social worker and/or nurse)
* The Recovery Café aims to provide a space for patients to listen to each other and share their experiences around themes related to the different dimensions of recovery: medical and psychological, economic, professional, social and existential.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Frédéric ROCHE, PhD

Role: PRINCIPAL_INVESTIGATOR

CHU de Saint Etienne

Bienvenu BONGUE, phD

Role: STUDY_DIRECTOR

Jean Monnet University

Locations

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Urps Medecins Libéraux Auvergne-Rhône-Alpes

Lyon, , France

Site Status NOT_YET_RECRUITING

Chu Saint-Etienne

Saint-Etienne, , France

Site Status RECRUITING

DAC Loire

Saint-Etienne, , France

Site Status NOT_YET_RECRUITING

Countries

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France

Central Contacts

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Caroline DUPRE, PhD

Role: CONTACT

0477816352 ext. +33

References

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Kamdem OL, Dupre C, Heugno V, Baudot A, Essangui E, Blanquet M, Guercon N, Fanget M, Bayet S, Vericel MP, Oustric P, Mbama Biloa Y, Shikitele Lola E, Nekaa M, Debellis M, Stierlam F, Mbia RF, Tatsilong O, Assomo Ndemba P, Ngan WB, Ndobo V, Ayina Ayina C, Mekoulou J, Ndom Ebongue MS, Celarier T, Ruiz L, Regnier V, Bika C, Ngo Sack F, Ngondi JL, Barth N, Mandengue SH, Roche F, Botelho-Nevers E, Eboumbou Moukoko CE, Nguefeu Nkenfou C, Hupin D, Bongue B, Guyot J. SPACO+: a mixed methods protocol to assessing the effectiveness of an educative intervention in patients with Long Covid. BMC Infect Dis. 2025 Apr 29;25(1):623. doi: 10.1186/s12879-025-10992-6.

Reference Type DERIVED
PMID: 40301772 (View on PubMed)

Other Identifiers

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2020-A00982-37

Identifier Type: OTHER

Identifier Source: secondary_id

22CH550

Identifier Type: -

Identifier Source: org_study_id

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