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

NCT05787366 | Active Not Recruiting

• 2 other identifiers: 22CH5502020-A00982-37
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 3

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.

Conditions

COVID-19

Keywords

health pathway; quality of life; personalized multifactorial intervention

Outcome Measures

Primary Outcomes (1)

• the evolution of the quality of life

  measurement of quality of life at the end of the 6-month follow-up assess by the SF-36 questionnaire. This questionnaire has eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health. Each question is evaluated on a Likert scale, with 3, 5 or 6 levels of possible answers. The 8 dimensions are also used to calculate two quality of life scores for individuals: the physical composite score (PCS) and the mental composite score (MCS). The higher the score, the greater the ability.

  at the end of the 6-month follow-up

Secondary Outcomes (11)

• impact on quality of life

  at 3 months

• impact on frailty

  at 3 and 6 months

• impact on comorbidities

  at 3 and 6 months

• impact on dyspnea symptoms

  at 3 and 6 months

• impact on hyperventilation symptoms

  at 3 and 6 months

Other Outcomes (2)

• obstacles and levers to participation and adherence to the intervention, as well as the satisfaction of patients and professionals

  at 3 and 6 months

• Effectivness of the intervention

  at 6 months

Study Arms (2)

Usual care

OTHER

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.

Other: usual care and follow-up by a nurse

Intervention group

EXPERIMENTAL

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

Other: Personalized Multifactorial Intervention (IMP)

Interventions

usual care and follow-up by a nurse OTHER

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

Usual care

Personalized Multifactorial Intervention (IMP) 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.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (3)

Urps Medecins Libéraux Auvergne-Rhône-Alpes

Lyon, 69006, France

Location

Chu Saint-Etienne

Saint-Etienne, 42055, France

Location

DAC Loire

Saint-Etienne, 42100, France

Location

Related Publications (1)

• 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.

  PMID: 40301772 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Inosine Monophosphate

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Inosine Nucleotides; Purine Nucleotides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Study Officials

• Frédéric ROCHE, PhD

  CHU de Saint Etienne

  PRINCIPAL INVESTIGATOR

• Bienvenu BONGUE, phD

  Jean Monnet University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, multicenter, controlled, randomized open-labelled study

Study Record Dates

• First Submitted: March 24, 2023
• First Posted: March 28, 2023
• Study Start: November 15, 2023
• Primary Completion: September 12, 2025
• Study Completion (Estimated): October 1, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)