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MTOP: Trajectories of Chronic Multimorbidity Patterns in Older Patients

Sponsor
Corporacion Parc Tauli (Other)
Overall Status
Recruiting
CT.gov ID
NCT05717309
Collaborator
Department of Health, Generalitat de Catalunya (Other)
3,988
Enrollment
1
Location
22.6
Anticipated Duration (Months)
176.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Following the MRisk-COVID project, MTOP (Multimorbidity Trajectories in Older Patients) study was developed. It is a retrospective observational study using Real World Data that aims to identify patterns of chronic multimorbidity in patients aged ≥65 years and their evolution and trajectories in the previous 10 years. The secondary objective is to identify the relationship between the trajectories of multimorbidity patterns in the previous 10 years and the severity of the infection by COVID-19.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Multimorbidity is associated with negative results and presents difficulties in clinical management. Recently, new methodologies are emerging based on the hypothesis that chronic conditions are associated in a non-random way forming multimorbidity patterns. However, there are few studies that study the temporal evolution and trajectories of these multimorbidity patterns, which could be associated with different prognoses and could allow better forecasting and planning. The primary objective of this analysis is to identify patterns of chronic multimorbidity in patients aged ≥65 years and their evolution and trajectories in the previous 10 years, using part of the MRisk-COVID project data. As a secondary objective, the investigators want to identify the relationship between the trajectories of multimorbidity patterns in the previous 10 years and the severity of the COVID-19 infection. This retrospective observational study has a historical cohort of 3958 patients ≥65 years of age suspected and confirmed of COVID-19 infection from February 1 to June 15, 2020 in the reference area of Parc Taulí University Hospital. The available data (real-world data) are socio-demographic and diagnostic variables provided by the Data Analytics Program for Research and Innovation in Health (PADRIS), which include sex, age and primary care diagnoses. To identify patterns of multimorbidity, the Clinical Classification Software, Chronic Condition Indicator, multiple correspondence analysis and cluster analysis using the fuzzy c-means algorithm will be used. Then, a clinical consensus process (Delphi-like) will be made of the clusters obtained. To identify the most probable trajectories along the three time points, each patient will be assigned to the cluster with the highest probability of membership. Descriptive and bivariate statistics will be performed.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    3988 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Trajectories of Chronic Multimorbidity Patterns in Patients >65 Years Old. MTOP
    Actual Study Start Date :
    Feb 10, 2022
    Actual Primary Completion Date :
    Jan 17, 2023
    Anticipated Study Completion Date :
    Dec 31, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Chronic multimorbidity patterns - Time Frame 1 [Baseline (2020)]

      Obtained using fuzzy c-means cluster analysis

    2. Chronic multimorbidity patterns - Time Frame 2 [5 years before (2015)]

      Obtained using fuzzy c-means cluster analysis

    3. Chronic multimorbidity patterns - Time Frame 3 [10 years before (2010)]

      Obtained using fuzzy c-means cluster analysis

    4. Trajectories of chronic multimorbidity patterns [Change over 10 years]

      Obtained by assigning the highest probable cluster at each time point

    Secondary Outcome Measures

    1. Severe COVID-19 infection [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years to 94 Years
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    • Positive results of COVID-19 laboratory tests

    • COVID-19 related clinical profile verified by healthcare professionals

    Exclusion Criteria:
    • Males >90 years (re-identification risk)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Corporacio Parc Taulí Sabadell Barcelona Spain 08208

    Sponsors and Collaborators

    • Corporacion Parc Tauli
    • Department of Health, Generalitat de Catalunya

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Marina Lleal Custey, Principal Investigator, Corporacion Parc Tauli
    ClinicalTrials.gov Identifier:
    NCT05717309
    Other Study ID Numbers:
    • CIR2021038
    First Posted:
    Feb 8, 2023
    Last Update Posted:
    Feb 8, 2023
    Last Verified:
    Feb 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Marina Lleal Custey, Principal Investigator, Corporacion Parc Tauli
    Multimorbidity
    Cluster analysis
    Trajectories
    Older patient
    COVID-19
    Additional relevant MeSH terms:
    Chronic Disease

    Study Results

    No Results Posted as of Feb 8, 2023