An observational study in Rheumatoid Arthritis and Quality of Life, sponsored by National Institute of Medical Sciences and Nutrition, Salvador Zubiran. Completed at 1 site in Mexico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-09-28.
Sponsored by National Institute of Medical Sciences and Nutrition, Salvador Zubiran · Observational
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.
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).
3,332 studies on the registry are indexed under Arthritis, Rheumatoid; 443 are open to participants now.
This study's enrollment of 670 is above the median of 176 across 1,016 observational studies indexed under Arthritis, Rheumatoid.
Browse Arthritis, Rheumatoid studies →National Institute of Medical Sciences and Nutrition, Salvador Zubiran is the lead sponsor of 16 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
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Exclusion Criteria:
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 · Other: RAPID-3 · Other: WHOQOL-BREF · Other: DASS-21 instrument (depression and anxiety) · Other: IER-R (posttraumatic stress)
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
The instrument measures function, pain, and patient global estimate of status, with correspond to activity disease
The instrument measures the patient´s quality of life (4 dimensions: physics, phycological, social, and environment)
The instrument measures the presence of depression and anxiety
The instrument measures the presence of posttraumatic stress
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)
Time frame: At study inclusion (The first medical consultation posterior to open the external outpatient's service, post COVID-19 pandemic)
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
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 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)
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 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
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 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
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 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
Time frame: In the first medical consultation posterior to open the external outpatient's service (post COVID-19 pandemic) to 6 months follow-up
Plan to share: No
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This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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National Institute of Medical Sciences and Nutrition, Salvador Zubiran