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

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04557358
• Other study ID #: IRE-3467
• Status: Completed
• Start date: October 1, 2020
• Est. completion date: May 31, 2021

Study information

• Verified date: September 2022
• Source: National Institute of Medical Sciences and Nutrition, Salvador Zubiran
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 670
• Est. completion date: May 31, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Collagen Diseases
• COVID-19
• Quality of Life
• Rheumatic Diseases
• Rheumatoid Arthritis

Intervention

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
• RAPID-3
The instrument measures function, pain, and patient global estimate of status, with correspond to activity disease
• WHOQOL-BREF
The instrument measures the patient´s quality of life (4 dimensions: physics, phycological, social, and environment)
• DASS-21 instrument (depression and anxiety)
The instrument measures the presence of depression and anxiety
• IER-R (posttraumatic stress)
The instrument measures the presence of posttraumatic stress

Locations

Country	Name	City	State
Mexico	Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán	Mexico City	Tlalpan

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Medical Sciences and Nutrition, Salvador Zubiran

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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