Selection of Patients With Chronic Inflammatory Rheumatism Requiring Management During the COVID-19 Pandemia (SePaRIC)

Selection of Patients With Chronic Inflammatory Rheumatism Requiring Management During the COVID-19 Pandemia Through an Innovative Organizational Strategy

The project proposes to evaluate a strategy for prioritizing teleconsultation for patients with chronic inflammatory rheumatic diseases during the COVID-19 pandemia. This selection will be done through telephone contact by medical students, supervised by residents and rheumatologists on a patient database. The other objectives are to assess the impact of the pandemia on the physical and mental health of patients classified as being at risk

Study Overview

• Status: Completed
• Conditions: Covid19; Rheumatoid Arthritis; Inflammatory Arthritis; Spondyloarthritis; Inflammatory Rheumatism
• Intervention / Treatment: Other: SePaRIC-Covid19 cohort

Detailed Description

The COVID-19 pandemic led to the suspension of consultations and hospitalization of the majority of patients followed in the Rheumatology Department of the Limoges University Hospital.

The department therefore implemented a strategy for the management of patients with chronic inflammatory rheumatism (CIR) during this period, which allowed maintaining contact with patients in the patient database.

During this telephone call, an CIR-Covid19 questionnaire was fulfilled in order to prioritize patients requiring rapid management.

The strategy is based on the use of the available health reserve, i.e. volunteered medical students to provide patient management assistance. These students were trained with face-to-face learning in the rheumatology department given by residents on chronic inflammatory rheumatism to remind them of all the elements of diagnosis and management. They had an interview with a senior rheumatologist from the Department to present the questionnaire and its objectives , to give them advice regarding communication with patients, as well as information about the COVID-19 infection and recommendations of the French Rheumatology Society for CIR patients. The students were trained with quizzes on practical situations, with feedback on the answers.

The information's collected in the questionnaire were based on the patients' feelings. Telephone communication does not allow an assessment of disease activity according to validated criteria as it requires a clinical examination.

The opinion of the referring rheumatologist was requested by the patients or by the medical student at the end of the telephone call, depending on the information collected. At any time, the medical students could call upon to senior doctors from the department or residents in case of difficulties.

943 patients were thus contacted between 14/04/2020 and 28/04/2020. They were able to benefit from an optimized management according to the context of the COVID19 pandemic.

These questionnaires were analyze in order to assess the need for specialized follow-up during this period and to evaluate the impact of COVID19 on this population.

• Study Type: Observational
• Enrollment (Actual): 918

Contacts and Locations

Study Locations

• France
  • Limoges, France, 87000
    • Service de Rhumatologie, CHu de Limoges

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic inflammatory rheumatism

Description

Inclusion Criteria:

• Patients with chronic inflammatory rheumatism who answered the RIC-COVID19 survey during the telephone call set up by the Rheumatology Department of the Limoges University Hospital during the confinement.

Exclusion Criteria:

• Patients objecting to the use of their data

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients requiring an advice from the referring rheumatologist following the telephone survey.	Number of request for advice from the referring Rheumatologist by the student and/or the patient	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the association between rheumatologist advice asked by student and/or patient and the factors studied	Request for an advice from the referring rheumatologist by the student and/or the patient and the factors studied. Factors studied: Sex, age, department of residence, RA or AS COVID-19 symptoms, increase in CIR activity, increase in pain, discontinuation of treatment, increase in stress and anxiety, increase in depression, increase in fatigue, increase in sleep disorders, fear of coming to consultation or hospitalization, adaptability with their rheumatic disease, medical loneliness.	2 months
COVID-19 infection evaluation in the monitored patient population	Evaluate the proportion of COVID-19 infection in patients monitored in the Rheumatology department at Limoges University Hospital Proportion of COVID-19 serological tests performed and their positivity in this patient population.	2 months
Proportion of patients informed about COVID-19	Evaluate the proportion of patients having received medical information about the Covid-19 pandemic.	2 months
Evaluate the association between the increase in rheumatic activity perceived by patients and the factors studied	Evaluate the association between the increase in rheumatic activity perceived by patients and the factors studied using numerical scale of satisfaction following this call from patients and students (0-10) 0: unsatisfied, 10 : fully satisfied	2 months
Evaluate the association between pain increase perceived by patients and the factors studied	Percentage increase in pain perceived by patients during the epidemic and factors studied, evaluated by numerical scale during the phone call 0% to 100% (0% represente no pain, and 100% maximal pain)	2 months
Evaluate the association between rheumatologist advice asked by student and the factors studied	request for an advice from the referring rheumatologist by the student and the factors studied	2 months
Evaluate the association between rheumatologist advice asked by patient and the factors studied	request for an advice from the referring rheumatologist by the patient and the factors studied.	2 months
To evaluate the satisfaction of the telephone call with patients and students. Time Frame: phone call day	Numerical scale of satisfaction following this call from patients and students (0-10) 0: unsatisfied, 10 : fully satisfied	2 months

Collaborators and Investigators

• Sponsor: University Hospital, Limoges
• Investigators: Principal Investigator: Pascale PV Vergne-Salle, MD-PhD, University Hospital, Limoges

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2020
• Primary Completion (Actual): July 1, 2020
• Study Completion (Actual): July 31, 2020

Study Registration Dates

• First Submitted: December 9, 2020
• First Submitted That Met QC Criteria: March 18, 2021
• First Posted (Actual): March 19, 2021

Study Record Updates

• Last Update Posted (Actual): April 1, 2021
• Last Update Submitted That Met QC Criteria: March 29, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Chronic Inflammatory Rheumatism - COVID-19
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Joint Diseases; Musculoskeletal Diseases; Connective Tissue Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Gram-Positive Bacterial Infections; Spinal Diseases; Bone Diseases; Bone Diseases, Infectious; COVID-19; Arthritis; Rheumatic Diseases; Collagen Diseases; Spondylitis; Spondylarthritis; Rheumatic Fever
• Other Study ID Numbers: 87RI20_0044 (SePaRIC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No