Impact in the Medical Care Among the Rheumatic Diseases Patients in a Hospital in México During COVID-19 Pandemic

Completed

• Conditions: Rheumatoid Arthritis; Quality of Life

• Registration Number: NCT04557358
• Lead Sponsor: National Institute of Medical Sciences and Nutrition, Salvador Zubiran

Brief Summary

The National Institute of Medical Sciences and Nutrition is a national reference center for rheumatic diseases that belongs to The National Institutes of Health, and has Federal founding. More than 8,000 patients with a wide variety of rheumatologic diagnosis receive medical care.

On March 2020, the WHO announced COVID-19 outbreak a pandemic. The first case was registered in Mexico on February 2020. In March 2020, the Mexican Government requested that our Institution should restrict health care to exclusively COVID-19 patients; accordingly, outpatient consultations were, and up to August 2020 still, hold on.

Meanwhile, when possible, the Department of Immunology and Rheumatology has implemented an "on-demand", non-organized patient´s health care, through email and phone contact; nonetheless, and due to the middle-low socioeconomic status of most of our patients and limited technical resources available at our Institution, the attempt has been challenging.

Detailed Description

The aim objective of this project is to explore patients perception about access to medical care and to medications, access to communication with their primary rheumatologist and patients risk perception about COVID-19 disease, for this a survey directed (questionnaire locally developed) will apply and to explore how the reintegration at the usual medical care has a positive impact in the patient´s disease activity, patient´s quality of life and psychopathology (depression, anxiety and posttraumatic stress).

Study Timeline

• Study First Submitted: 2020-09-16
• Study First Submitted QC: 2020-09-17
• Study First Posted: 2020-09-21
• Study Start: 2020-10-01
• Primary Completion: 2021-05-31
• Study Completion: 2021-05-31
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-26
• Last Update Posted: 2022-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 670

Inclusion Criteria

• Patients with a rheumatic disease diagnosis according to their primary rheumatologist who agree to participate

Exclusion Criteria

• Patients with a not confirmed rheumatic disease
• Patients lost to follow-up from the outpatient for > 1 year period
• Patients with pregnancy plans

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in the pattern of the usual medical care among the rheumatic disease patients	At study inclusion (The first medical consultation posterior to open the external outpatient's service, post COVID-19 pandemic)	To determinate the proportion of the rheumatic disease patients affected in their usual medical care during the COVID-19 pandemic in our Institution with the COVID-19 survey (locally development)

Secondary Outcome Measures

Name	Time	Method
Change in the patient's activity disease	In the first medical consultation posterior to open the external outpatient's service (post COVID-19 pandemic) to 6 months follow-up	Change in the activity disease measured as RAPID-3 of the Rheumatic disease patients in a 6 months follow-up. The results will express with a scale 0 to 30 a \> number \> disease activity
Change in patient´s quality of life	In the first medical consultation posterior to open the external outpatient's service (post COVID-19 pandemic) to 6 months follow-up	Change in the quality of life measured as WHOQOL-BREF of the Rheumatic disease patients in a 6 months follow-up. The results will express with a scale 0 to 100 a \> number \> quality of life
Change in patient´s posttraumatic stress	In the first medical consultation posterior to open the external outpatient's service (post COVID-19 pandemic) to 6 months follow-up	Change in the psychopathology measured as IER-R (posttraumatic stress) of the Rheumatic disease patients in a 6 months follow-up. The results will express with a scale 0 to 88 a cut of point \> 24 would be significant
Change in the patient's activity disease measures by their rheumatologist	In the first medical consultation posterior to open the external outpatient's service (post COVID-19 pandemic) to 6 months follow-up	Change in the activity disease measured by their rheumatologist (4 questions) of the rheumatic disease patients in a 6 months follow-up. The results will express with 3 categories (without activity, low activity, moderate activity, high activity)
Change in patient´s depression and anxiety	In the first medical consultation posterior to open the external outpatient's service (post COVID-19 pandemic) to 6 months follow-up	Change in the psychopathology measured as DASS-21 instrument (depression and anxiety) of the Rheumatic disease patients in a 6 months follow-up. The results will express with a scale 0 to 8 a cut of point \> 8 suggests depression and stress presence, and \> 5 suggests anxiety presence

Trial Locations

Locations (1)

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán; 🇲🇽 Mexico City, Tlalpan, Mexico