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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

670

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Oct 2020

Shorter than P25 for all trials

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

8 months study duration

First Submitted

Initial submission to the registry

September 16, 2020

Completed

5 days until next milestone

First Posted

Study publicly available on registry

September 21, 2020

Completed

10 days until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed

8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2021

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2021

Completed

Last Updated

September 28, 2022

Status Verified

September 1, 2022

Enrollment Period

8 months

First QC Date

September 16, 2020

Last Update Submit

September 26, 2022

Conditions

Rheumatoid Arthritis Quality of Life

Outcome Measures

Primary Outcomes (1)

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 Outcomes (5)

Change in the patient's activity disease
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
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
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
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
In the first medical consultation posterior to open the external outpatient's service (post COVID-19 pandemic) to 6 months follow-up

Study Arms (1)

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 surveyOther: RAPID-3Other: WHOQOL-BREFOther: DASS-21 instrument (depression and anxiety)Other: IER-R (posttraumatic stress)

Interventions

COVID-19 surveyOTHER

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