Chronic DiseaseMTOPNCT05717309
Trajectories of Chronic Multimorbidity Patterns in Older Patients
An observational study of Chronic Disease, run by Corporacion Parc Tauli at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 94 years
- Conditions the study is for
- Chronic Disease
- How many people
- 3,988 participants
- Where
- 1 siteSpain
- Study dates
- 10 Feb 2022to 31 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 94 years
- All sexes
- Older adult
Study population: Confirmed or suspected COVID-19 patients from the first wave of the pandemic, aged 65 years and over, residing in a healthcare region of about 400.000 inhabitants in a Northeast region of Spain (Vallès Occidental Est, Catalonia, Spain).
Who may be able to join
- Positive results of COVID-19 laboratory tests
- COVID-19 related clinical profile verified by healthcare professionals
Who cannot join
- Males >90 years (re-identification risk)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Trajectories of Chronic Multimorbidity Patterns in Patients >65 Years Old. MTOP
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.
Read the 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.
- Conditions
- Chronic Disease
- Keywords
- Multimorbidity, Cluster analysis, Trajectories, Older patient, COVID-19
- Medical subject headings
- Chronic Disease, COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic multimorbidity patterns - Time Frame 1
Obtained using fuzzy c-means cluster analysis
Measured: Baseline (2020)
Chronic multimorbidity patterns - Time Frame 2
Obtained using fuzzy c-means cluster analysis
Measured: 5 years before (2015)
Chronic multimorbidity patterns - Time Frame 3
Obtained using fuzzy c-means cluster analysis
Measured: 10 years before (2010)
Trajectories of chronic multimorbidity patterns
Obtained by assigning the highest probable cluster at each time point
Measured: Change over 10 years
Secondary outcomes (1)
Severe COVID-19 infection
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
Measured: From 27-February-2020 to 15-June-2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start10 Feb 2022
- Primary completion17 Jan 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 3,988 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health, Generalitat de Catalunya
- Responsible party
- Principal investigator, Marina Lleal Custey, Corporacion Parc Tauli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05717309
- Sponsor's protocol ID
- CIR2021038
- Acronym
- MTOP
- Status last verified
- Aug 2023
- First submitted
- 25 Jan 2023
- Last updated
- 24 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lleal M, Bare M, Herranz S, Orus J, Comet R, Jordana R, Bare M. Trajectories of chronic multimorbidity patterns in older patients: MTOP study. BMC Geriatr. 2024 May 30;24(1):475. doi: 10.1186/s12877-024-04925-2.
PubMed 38816787
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trajectories of Chronic Multimorbidity Patterns in Patients >65 Years Old. MTOP
- ClinicalTrials.gov ID
- NCT05717309
- Acronym / sponsor ID
- MTOP / CIR2021038
- Conditions
- Chronic Disease
- Keywords
- Multimorbidity, Cluster analysis, Trajectories, Older patient, COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,988 participants (actual)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Collaborators
- Department of Health, Generalitat de Catalunya
- Study start
- 10 Feb 2022 (actual)
- Primary completion
- 17 Jan 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 8 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 65 to 94 years
- Sex
- All
- Age groups
- Older adult
- Study population
- Confirmed or suspected COVID-19 patients from the first wave of the pandemic, aged 65 years and over, residing in a healthcare region of about 400.000 inhabitants in a Northeast region of Spain (Vallès Occidental Est, Catalonia, Spain).
Key inclusion criteria (2 listed)
- Positive results of COVID-19 laboratory tests
- COVID-19 related clinical profile verified by healthcare professionals
Key exclusion criteria (1 listed)
- Males >90 years (re-identification risk)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Chronic multimorbidity patterns - Time Frame 1
Time frame: Baseline (2020)
Obtained using fuzzy c-means cluster analysis
Chronic multimorbidity patterns - Time Frame 2
Time frame: 5 years before (2015)
Obtained using fuzzy c-means cluster analysis
Chronic multimorbidity patterns - Time Frame 3
Time frame: 10 years before (2010)
Obtained using fuzzy c-means cluster analysis
Trajectories of chronic multimorbidity patterns
Time frame: Change over 10 years
Obtained by assigning the highest probable cluster at each time point
1 secondary outcome
Severe COVID-19 infection
Time frame: From 27-February-2020 to 15-June-2020
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2023.
- Derived from this study: PubMed 38816787Lleal M, Bare M, Herranz S, Orus J, Comet R, Jordana R, Bare M. Trajectories of chronic multimorbidity patterns in older patients: MTOP study. BMC Geriatr. 2024 May 30;24(1):475. doi: 10.1186/s12877-024-04925-2.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Disease, run by Corporacion Parc Tauli at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chronic multimorbidity patterns - Time Frame 1 (time frame: Baseline (2020)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05717309, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2023.