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

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

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Rheumatoid Arthritis
• Intervention / Treatment: Other: COVID-19 survey; Other: RAPID-3; Other: WHOQOL-BREF; Other: DASS-21 instrument (depression and anxiety); Other: IER-R (posttraumatic stress)

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 Type: Observational
• Enrollment (Actual): 670

Contacts and Locations

Study Locations

• Mexico
  • Tlalpan
    • Mexico City, Tlalpan, Mexico, 14080
      • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

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: Probability Sample

Study Population

All the rheumatic diseases outpatients from the National Institute of Medical Sciences and Nutrition that will assist their usual medical care posterior of stopped it during the COVID-19 pandemic.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Rheumatic diseases outpatients; All the rheumatic diseases outpatients from the National Institute of Medical Sciences and Nutrition that will assist their usual medical care posterior of stopped it during the COVID-19 pandemic. In order to explore how the patient´s disease activity, patient´s quality of life, and psychopathology will change with the reintegration at medical care, randomization 200 rheumatic diseases outpatients that will respond RAPID-3 (disease activity/disease severity), WHOQOL-BREF instrument (quality of life), DASS-21 instrument (depression and anxiety), IER-R (posttraumatic stress)

Other: COVID-19 survey; A questionnaire locally developed to explore access to medical care and to medications, access to communication with their primary rheumatologist, and patients risk perception about COVID-19 disease; Other: RAPID-3; The instrument measures function, pain, and patient global estimate of status, with correspond to activity disease; Other: WHOQOL-BREF; The instrument measures the patient´s quality of life (4 dimensions: physics, phycological, social, and environment); Other: DASS-21 instrument (depression and anxiety); The instrument measures the presence of depression and anxiety; Other: IER-R (posttraumatic stress); The instrument measures the presence of posttraumatic stress

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the pattern of the usual medical care among the rheumatic disease patients	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)	At study inclusion (The first medical consultation posterior to open the external outpatient's service, post COVID-19 pandemic)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the patient's activity disease	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	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 patient's activity disease measures by their rheumatologist	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)	In the first medical consultation posterior to open the external outpatient's service (post COVID-19 pandemic) to 6 months follow-up
Change in patient´s quality of life	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	In the first medical consultation posterior to open the external outpatient's service (post COVID-19 pandemic) to 6 months follow-up
Change in patient´s depression and anxiety	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	In the first medical consultation posterior to open the external outpatient's service (post COVID-19 pandemic) to 6 months follow-up
Change in patient´s posttraumatic stress	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	In the first medical consultation posterior to open the external outpatient's service (post COVID-19 pandemic) to 6 months follow-up

Collaborators and Investigators

• Sponsor: National Institute of Medical Sciences and Nutrition, Salvador Zubiran

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2020
• Primary Completion (ACTUAL): May 31, 2021
• Study Completion (ACTUAL): May 31, 2021

Study Registration Dates

• First Submitted: September 16, 2020
• First Submitted That Met QC Criteria: September 17, 2020
• First Posted (ACTUAL): September 21, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 28, 2022
• Last Update Submitted That Met QC Criteria: September 26, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• 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; Musculoskeletal Diseases; Connective Tissue Diseases; COVID-19; Rheumatic Diseases; Collagen Diseases
• Other Study ID Numbers: IRE-3467

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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