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NCT Number: NCT05717309

Trajectories of Chronic Multimorbidity Patterns in Older Patients

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.

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Key information

Conditions

Chronic Disease COVID-19 Coronaviridae Infections Coronavirus Infections Disease Attributes Infections Lung Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

65 year–94 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Corporacio Parc Taulí

Sabadell, Barcelona, 08208, Spain

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Chronic multimorbidity patterns - Time Frame 1

    Time frame: Baseline (2020)

    Obtained using fuzzy c-means cluster analysis

  2. Chronic multimorbidity patterns - Time Frame 2

    Time frame: 5 years before (2015)

    Obtained using fuzzy c-means cluster analysis

  3. Chronic multimorbidity patterns - Time Frame 3

    Time frame: 10 years before (2010)

    Obtained using fuzzy c-means cluster analysis

  4. Trajectories of chronic multimorbidity patterns

    Time frame: Change over 10 years

    Obtained by assigning the highest probable cluster at each time point

Secondary outcomes

  1. Severe COVID-19 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

Sponsors and collaborators

Lead sponsor

Corporacion Parc Tauli

Other

Collaborators

  • Department of Health, Generalitat de Catalunya

Registry information

Official study title

Trajectories of Chronic Multimorbidity Patterns in Patients >65 Years Old. MTOP

Acronym: MTOP

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 8, 2023
Registry last updated
Aug 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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