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

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ClinicalTrials.gov Identifier: NCT04557358
Recruitment Status : Recruiting
First Posted : September 21, 2020
Last Update Posted : September 21, 2020
Sponsor:
Information provided by (Responsible Party):
Virginia Pascual Ramos, 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.


Condition or disease Intervention/treatment
Rheumatoid Arthritis Quality of Life 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).

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Study Type : Observational
Estimated Enrollment : 346 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact in the Medical Care Among the Rheumatic Diseases Patients in a Tertiary Hospital in México During the COVID-19 Pandemic
Actual Study Start Date : July 1, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04557358


Locations
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Mexico
Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán Recruiting
Mexico City, Tlalpan, Mexico, 14080
Contact: Virginia Pascual, MD    00525555734111    virtichu@gmail.com   
Sub-Investigator: Irazú Contreras, Msc         
Sponsors and Collaborators
National Institute of Medical Sciences and Nutrition, Salvador Zubiran
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Responsible Party: Virginia Pascual Ramos, Principal Investigator, National Institute of Medical Sciences and Nutrition, Salvador Zubiran
ClinicalTrials.gov Identifier: NCT04557358    
Other Study ID Numbers: IRE-3467
First Posted: September 21, 2020    Key Record Dates
Last Update Posted: September 21, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Rheumatic Diseases
Collagen Diseases
Musculoskeletal Diseases
Connective Tissue Diseases