Chronic Multimorbidity Patterns in Relation to COVID-19 Severe Infection (Mrisk-COVID)
July 28, 2021 updated by: Marisa Baré, MD, MPH, PhD, Corporacion Parc Tauli
Risk of Severe COVID-19, Taking Into Account Multimorbidity Patterns, as Well as Other Clinical and Sociodemographic Variables. Big Data Mrisk-COVID Project
The aim of the study was to analyze the patterns of chronic multimorbidity of a cohort of Covid-19 patients, and to assess the relation between the patterns and the development of severe infection or mortality.
Study Overview
Status
Completed
Conditions
Detailed Description
This is a Big Data study that aims to establish the multimorbidity (MM) clusters of a cohort of Covid-19 patients, and assess their potential relation with severe infection or mortality.
Databases of demographic information and complete medical records from the cohort will be provided by the Agency for Health Quality and Assessment of Catalonia (AQuAS).
Data will be collected and integrated in a complete database in order to define the study variables: multimorbidity patterns, COVID-19 severe infection and COVID-19 associated mortality.
The population will be stratified by sex and age (21-45, 46-65, 66-80 and 81-95 years).
Diagnoses from primary care and hospitals will be filtered and classified using the Chronic Condition Indicator v.2021 and the Clinical Classification Software v.2021 [1], in order to identify the Chronic Conditions (CC) of the patients.
CC with prevalence >2% in each age-sex strata will be subjected to a fuzzy c-means clustering analysis.
The final number of clusters in each age-sex group will be determined under the clinical criteria of the research group members.
Percentages of patients that suffered severe Covid-19 infection or death in each cluster will be calculated.
Bivariate statistical analysis comparing the demographic data and the cluster distribution with severe infection and mortality will be performed.
Study Type
Observational
Enrollment (Actual)
14286
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Sabadell, Spain, 08208
- Corporació Parc Tauli
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 95 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Confirmed or suspected Covid-19 patients from the first wave of the pandemic, aged >20 years, residing in a healthcare region of about 400.000 inhabitants in a Northeast region of Spain (Vallès Occidental Est, Catalonia, Spain).
Description
Inclusion Criteria:
- Positive results of Covid-19 laboratory tests
- Covid-19 related clinical profile verified by healthcare professionals
Exclusion Criteria:
- Male >90 years
- Females >95 years
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Covid-19 severe infection
Time Frame: From 27-February-2020 to 15-June-2020
|
Severe COVID-19 infection was defined as the occurrence of at least one of the following conditions during any of the registered COVID-19 episodes: severe respiratory affection (including insufficiency, failure, or distress); use of respiratory support (including mechanical ventilation or oxygen therapy); septic shock; multiple organ failure (the combination of respiratory failure and any other organ failure); inflammatory response; admission to intensive care unit; and mortality.
|
From 27-February-2020 to 15-June-2020
|
|
Covid-19 mortality
Time Frame: From 27-February-2020 to 15-June-2020
|
Death associated to COVID-19 infection episode
|
From 27-February-2020 to 15-June-2020
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2021
Primary Completion (Actual)
January 31, 2021
Study Completion (Actual)
May 31, 2021
Study Registration Dates
First Submitted
July 27, 2021
First Submitted That Met QC Criteria
July 27, 2021
First Posted (Actual)
July 28, 2021
Study Record Updates
Last Update Posted (Actual)
August 4, 2021
Last Update Submitted That Met QC Criteria
July 28, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CIR 2020/023
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.