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Completed

NCT Number: NCT04557358

Impact in the Medical Care Among the Rheumatic Diseases Patients in a Hospital in México During 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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Quality of Life Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

Mexico City, Tlalpan, 14080, Mexico

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

COVID-19 survey

Other

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

Other

The instrument measures function, pain, and patient global estimate of status, with correspond to activity disease

WHOQOL-BREF

Other

The instrument measures the patient´s quality of life (4 dimensions: physics, phycological, social, and environment)

DASS-21 instrument (depression and anxiety)

Other

The instrument measures the presence of depression and anxiety

IER-R (posttraumatic stress)

Other

The instrument measures the presence of posttraumatic stress

Primary outcomes

  1. Change in the pattern of the usual medical care among the rheumatic disease patients

    Time frame: 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 outcomes

  1. Change in the patient's activity disease

    Time frame: 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

  2. Change in the patient's activity disease measures by their rheumatologist

    Time frame: 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)

  3. Change in patient´s quality of life

    Time frame: 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

  4. Change in patient´s depression and anxiety

    Time frame: 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

  5. Change in patient´s posttraumatic stress

    Time frame: 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

Sponsors and collaborators

Lead sponsor

National Institute of Medical Sciences and Nutrition, Salvador Zubiran

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Sep 21, 2020
Registry last updated
Sep 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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