Education of Medical Staff to Post Acute Covid susTained sYmptoms

NCT06082258 | Not Yet Recruiting

• 4 other identifiers: APHP220136ECTZ1993832022-A00531-42DR-2023-132
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 7

Brief Summary

Evaluation of the effectiveness of a training and support intervention for general practitioners treating patients with persistent symptoms after a COVID-19 episode on the patients'quality of life at 3 months.

Conditions

Post-acute COVID-19 Syndrome

Keywords

Long COVID; Post acute Covid syndrome; Somatic symptom disorder; Education

Outcome Measures

Primary Outcomes (1)

• Change of physical component summary (PCS) of 12-Item Short-Form Health Survey (SF-12v2) - quality of life scale at 3 months compared to the PCS at the inclusion of the patient

  Health-related quality of life variable measured using the Short Form Health Survey (SF-12v2): 12-item self-report that assesses physical and mental health related quality of life. The physical component summary (PCS) will be used. Normalized score ranges from 0 to 100, with higher scores indicating better physical health functioning.

  3 months

Secondary Outcomes (11)

• Change of physical component summary (PCS) of 12-Item Short-Form Health Survey (SF-12v2) - quality of life scale at 1 month compared to the PCS at the inclusion of the patient

  1 month

• Change of physical component summary (PCS) of 12-Item Short-Form Health Survey (SF-12v2) - quality of life scale at 6 months compared to the PCS at the inclusion of the patient

  6 months

• Change of mental component summary (MCS) of 12-Item Short-Form Health Survey (SF-12v2) - quality of life scale at 1 month compared to the MCS at the inclusion of the patient

  1 month

• Change of mental component summary (MCS) of 12-Item Short-Form Health Survey (SF-12v2) - quality of life scale at 3 months compared to the MCS at the inclusion of the patient

  3 months

• Change of mental component summary (MCS) of 12-Item Short-Form Health Survey (SF-12v2) - quality of life scale at 6 months compared to the MCS at the inclusion of the patient

  6 months

Study Arms (2)

usual care

NO INTERVENTION

Patients followed by general practitioners with no specific education on long COVID or somatic symptom disorders

intervention

EXPERIMENTAL

Patients followed by general practitioners who have received a training in long COVID and somatic symptom disorders diagnosis and treatment, with reimbursement of three long consultations

Other: Training in the management of functional disorders; Other: Reimbursement of 3 long consultations

Interventions

Training in the management of functional disorders OTHER

Theoritical and practical training of GP in long COVID and somatic symptom disorders management

intervention

Reimbursement of 3 long consultations OTHER

3 long consultations (1 hour) reimbursed for each patient

intervention

Eligibility Criteria

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

You may qualify if:

• at least two symptoms attributed to COVID-19 (including fatigue, dyspnea, cognitive impairment or pain); persistent for more than 2 months; not explained by a diagnosis unrelated to COVID-19;
• a quality of life impairment considered significant by the patient.

You may not qualify if:

• Refusal to participate in the study
• Under 18 years of age
• Persistent symptoms secondary to an objective sequelae from the initial episode of COVID-19.
• Neuropsychiatric disorder that may impair cognitive function prior to COVID-19
• Medical contraindication to physical training (pericarditis or myocarditis...)
• Patient not affiliated with the social security system or under AME
• Patient under guardianship, guardianship or guardianship

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• ANRS, Emerging Infectious Diseases: collaborator

Study Sites (7)

Paris Nord (CPTS 10e)

Paris, 75010, France

Location

Paris Est (CPTS 12e et 20e)

Paris, 75012, France

Location

DAC 75

Paris, 75013, France

Location

Paris Sud (CPTS 13-14e)

Paris, 75013, France

Location

Paris Ouest (CPTS 15e)

Paris, 75015, France

Location

DAC 93

Saint-Denis, 93200, France

Location

DAC 92

Suresnes, 92150, France

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Brigitte Ranque, Pr

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tiffany Martin

CONTACT

+33 1 44 84 17 92; tiffany.martin@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2023
• First Posted: October 13, 2023
• Study Start: November 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: May 1, 2026
• Last Updated: July 11, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Two years after the last publication
• Access Criteria: Data sharing must be accepted by the sponsor and the PI based on a scientific project and scientific involvement of the PI team. Collaboration will be fostered. Data sharing must respect the agreements made with funders. Teams wishing obtain IPD must meet the sponsor and IP team to present scientific (and commercial) purpose, IPD needed, format of data transmission, and timeframe. Technical feasibility and financial support will be discussed before mandatory contractual agreement. Processing of shared data must comply with European General Data Protection Regulation (GDPR).

Locations

FR (7)