Clinical trial NCT04557358: Impact in the Medical Care Among the Rheumatic Diseases Patients in a Hospital in México During COVID-19 Pandemic
Official title: Impact in the Medical Care Among the Rheumatic Diseases Patients in a Tertiary Hospital in México During the COVID-19 Pandemic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Quality of Life
Lead sponsor: National Institute of Medical Sciences and Nutrition, Salvador Zubiran
Sponsor class: OTHER
First posted: 2020-09-21
Enrollment: 670
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).

Eligibility 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

Primary outcomes:
measure: Change in the pattern of the usual medical care among the rheumatic disease patients
timeFrame: At study inclusion (The first medical consultation posterior to open the external outpatient's service, post COVID-19 pandemic)
Secondary outcomes:
measure: Change in the patient's activity disease
timeFrame: In the first medical consultation posterior to open the external outpatient's service (post COVID-19 pandemic) to 6 months follow-up
measure: Change in the patient's activity disease measures by their rheumatologist
timeFrame: In the first medical consultation posterior to open the external outpatient's service (post COVID-19 pandemic) to 6 months follow-up
measure: Change in patient´s quality of life
timeFrame: In the first medical consultation posterior to open the external outpatient's service (post COVID-19 pandemic) to 6 months follow-up
measure: Change in patient´s depression and anxiety
timeFrame: In the first medical consultation posterior to open the external outpatient's service (post COVID-19 pandemic) to 6 months follow-up
measure: Change in patient´s posttraumatic stress
timeFrame: In the first medical consultation posterior to open the external outpatient's service (post COVID-19 pandemic) to 6 months follow-up
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
state: Tlalpan
Study officials:
affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
name: Virginia Pascual-Ramos, Dr.
role: PRINCIPAL_INVESTIGATOR
References: