ExerciseeMOBNCT05578495
Association of a Digital Signature of Physical Activity and Sedentary Lifestyle With the Development of Multimorbidities in Chronic Diseases (eMOB)
A study testing Accelerometer data in people with Exercise and Sedentary Behavior, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Physical activity (PA) and sedentary lifestyle are determinants in the development of chronic diseases and associated quality of life alterations. PA levels are correlated with quality of life and morbidity in chronic lung disease (COPD), cardiovascular disease, diabetes, cancer, chronic inflammatory rheumatism… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Exercise, Sedentary Behavior, Non Communicable Diseases
- What is being tested?
- Accelerometer data
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 1 siteFrance
- Study dates
- 7 Dec 2023to Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient follow-up at CHU Clermont-Ferrand for a chronic disease in one of the following observational cohorts:
- Inflammatory rheumatic disease(rheumatoid arthritis, spondyloarthritis) included in the RCVRIC cohort (CPP Sud-Est VI N° ID-RCB- A01847-40)
- Pre-surgical knee and hip osteoarthritis (Evalmob) (ID-RCB N° 2019- A01017-50)
- Major depressive disorder included in the FACE-DR cohort (CNIL agreement: DR- 2015-673) and Bipolar disorder included in the FACE-BD cohort (CPP Ile de France IX; January 18, 2010) of the Adult Psychiatry Department B
- Type 2 diabetes included in the cohort of the sport medicine service "Rehabilitation T2" (CNIL agreement 0164)
- Obesity included in the "Obesity" sports medicine service cohort (CNIL agreement 0164)
Show all 10Show fewer
- COPD included in the "COPD Rehabilitation" sports medicine service cohort (CNIL agreement 0164)
- Chronic pain cohort (eDOL) (CPP West II N° ID-RCB 2020-A02027-32)
- Affiliation to a social security system.
- Able to provide written informed consent to participate in the research.
Who cannot join
- Inability to practice physical activity
- Pregnant or breastfeeding
- Refusal to participate
- Minors or adults under the protection of the law or under the protection of justice.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Clermont-Ferrand
Clermont-Ferrand, 63000
Lise Laclautre, +33473754963, promo_interne_drci@chu-clermontferrand.fr
Anne Tournadre
About this study
Official title: Association of a Digital Signature of Physical Activity and Sedentary Lifestyle With the Development of Multimorbidities Over 4 Years of Follow-up in Chronic Diseases (eMOB) : a Prospective Cohort
Physical activity (PA) and sedentary lifestyle are determinants in the development of chronic diseases and associated quality of life alterations. PA levels are correlated with quality of life and morbidity in chronic lung disease (COPD), cardiovascular disease, diabetes, cancer, chronic inflammatory rheumatism, fibromyalgia and anxiety disorders. In these diseases, low-intensity PA often represents the main PA and the quantity of PA is correlated with health parameters.
This study aims to identify a typical profile (signature) in relation to the appearance of other chronic diseases, complications of your disease, from recording your physical activity and sedentary lifestyle by sensors evaluating very precisely the movements and taking into account the characteristics and disability related to your disease. The results of this study would therefore make it possible to identify this signature even before the appearance of complications or other diseases.
Read the detailed description
Study design :
eMOB study is a monocentric prospective cohort study. We aim to explore in a longitudinal study the association of a digital signature of PA and sedentary lifestyle with the development of at least one additionnal comorbidity overs 4 years of follow-up in chronic diseases.
Population :
Patients with inflammatory rheumatic disease(rheumatoid arthritis and spondyloarthritis), pre-surgical knee and hip osteoarthritis, major depressive disorder and bipolar disorder, type 2 diabetes, obesity, COPD and chronic pain followed up in the observational cohorts specific to each pathology at the CHU of Clermont Ferrand, will be proposed to participate in the study during their follow-up visit.
Method :
The occurrence of comorbidity is monitored every year during follow-up visits of the patients. Physical activity and sedentary lifestyle is assessed using accelerometer and wearable sensors. The combination of quantitative analysis of movement with a more detailed analysis of movement and sequences of movements, and a personalization of the algorithm according to the disease and the context, could make it possible to establish predictive signatures either of the disease itself or of associated complications.
700 patients will be included in the study.They will be followed for 4 years with :
- An annual visit during which :
- clinical data in the routine follow-up will be collected (BMI, waist circumference, blood pressure, heart rate, comorbidities, activity and severity scores specific to each disease and used for the routine follow-up, treatments, lifestyle, family and socio-professional situation, education level)
- comorbidities will be noted by the list used for the study
- physical capacity will be assessed with the 6-minute walk test and the hand grip
- questionnaires about Pain (QCD), Fatigue (FACIT-F), Anxiety and Depression (HADs), Quality of life (WhoQol-BREF), Poverty (EPICES), Physical activity questionnaire (RPAQ), Barriers and Facilitators to physical activity questionnaire (B\&F-AP), Sleep and daytime sleepiness (PSQI and Epworth), treatment compliance (MARS) will be completed
- specific data for each pathology in each cohort will be collected
- Accelerometer data 3 times a year for 5 days (3 weekdays and 2 weekend days) will be collected
- Electronic patient report outcomes (e-PRO) every 4 months concerning the socio-professional situation of the patients, alcohol and tobacco consumption, skipping meals and snacking between meals, health problems they may encounter during the study. Numerical scales between 0 and 10 will be completed to assess disease status, health status, pain, sleep, fatigue, psychological well-being, and anxiety.
Among the included patients, 10 patients per cohort will participate in the preliminary feasibility phase of the study before starting the follow-up in the study. It is a validation of the acquisition modalities of the pre-selected sensors and a calibration on representative samples of patients with the different chronic pathologies studied (locomotor, respiratory, metabolic, psychiatric, pain).
- Conditions
- Exercise, Sedentary Behavior, Non Communicable Diseases, Comorbidities and Coexisting Conditions, Comorbidity, Multimorbidity
- Being tested
- Accelerometer data
- Keywords
- Physical Activity, Sedentary Lifestyle, Chronic Diseases, Comorbidities, Multimorbidity, Personal digital health, Personalized medecine
- Medical subject headings
- Motor Activity, Sedentary Behavior, Noncommunicable Diseases, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accelerometer dataOther
Patients will wear an accelerometer 3 times a year for 5 days (3 weekdays and 2 weekend days), the data will be collected
| Study group | Role | What they receive |
|---|---|---|
| Chronic diseases | Other | Cohort Study Receives: Other: Accelerometer data |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of one additional comorbidity in patients with chronic diseases.
Association of a digital signature of PA and sedentary lifestyle with the development of at least one additional comorbidity over 4 years of follow-up.
Measured: year 4
Digital signature of sedentary lifestyle and PA in patients with chronic diseases.
A sensor of movement will be worn by the patients for 5 days every 4 months during the study, to detect and quantify the physical activity and the sedentarity according to their intensity. This sensor will be accelerometer, allowing the acquisition of movements second by second. The analysis of the data from the sensors, the occurrence of a new comorbidity, the clinical data will allow to establish an algorithm to define a profile (digital signature) of occurrence of a new chronic disease.
Measured: Year 4
Secondary outcomes (20)
Occurence of multimorbidity in patients with chronic diseases.
Association of a sedentary and PA signature with the development over 4 years of one, two, three, or more comorbidities (multimorbidity).
Measured: Year 1
Occurence of multimorbidity in patients with chronic diseases.
Association of a sedentary and PA signature with the development over 4 years of one, two, three, or more comorbidities (multimorbidity).
Measured: year 2
Occurence of multimorbidity in patients with chronic diseases.
Association of a sedentary and PA signature with the development over 4 years of one, two, three, or more comorbidities (multimorbidity).
Measured: Year 3
Occurence of multimorbidity in patients with chronic diseases.
Association of a sedentary and PA signature with the development over 4 years of one, two, three, or more comorbidities (multimorbidity).
Measured: Yaer 4
Correlation of PA/sedentary signature with destabilization or improvement/stability of the chronic condition.
Collect during the study clinical data, disease activity parameters in each cohort, physical capacity, and self questionnaires to explore PA/sedentary signature and its trajectory associated with destabilization or improvement/stability of the chronic condition.
Measured: Year 1
Correlation of PA/sedentary signature with destabilization or improvement/stability of the chronic condition.
Collect during the study clinical data, disease activity parameters in each cohort, physical capacity, and self questionnaires to explore PA/sedentary signature and its trajectory associated with destabilization or improvement/stability of the chronic condition.
Measured: Year 2
Correlation of PA/sedentary signature with destabilization or improvement/stability of the chronic condition.
Collect during the study clinical data, disease activity parameters in each cohort, physical capacity, and self questionnaires to explore PA/sedentary signature and its trajectory associated with destabilization or improvement/stability of the chronic condition.
Measured: Year 3
Correlation of PA/sedentary signature with destabilization or improvement/stability of the chronic condition.
Collect during the study clinical data, disease activity parameters in each cohort, physical capacity, and self questionnaires to explore PA/sedentary signature and its trajectory associated with destabilization or improvement/stability of the chronic condition.
Measured: Year 4
Correlation of PA/sendetary and treatments for chronic diseases.
Collect treatments of patients in each cohort at inclusion and each year over the study to explore PA/sedentary signature and its trajectory associated with achieving a decline in background treatments for chronic disease.
Measured: Year 1
Correlation of PA/sendetary and treatments for chronic diseases.
Collect treatments of patients in each cohort at inclusion and each year over the study to explore PA/sedentary signature and its trajectory associated with achieving a decline in background treatments for chronic disease.
Measured: year 2
Correlation of PA/sendetary and treatments for chronic diseases.
Collect treatments of patients in each cohort at inclusion and each year over the study to explore PA/sedentary signature and its trajectory associated with achieving a decline in background treatments for chronic disease.
Measured: Year 3
Correlation of PA/sendetary and treatments for chronic diseases.
Collect treatments of patients in each cohort at inclusion and each year over the study to explore PA/sedentary signature and its trajectory associated with achieving a decline in background treatments for chronic disease.
Measured: Year 4
Correlation of PA and sedentary measures and quality of life (QOL) of patients
Quality of life will be assessed with the World Health Organization Quality of Life Instruments (WhoQol-BREF) questionnaire, which has 26 items, divided into 4 domains: physical health, psychological, social relationship and environment. The score for each item ranges from 1 to 5. The score for each domain is calculated using a template designed by the WhoQol-BREF development team. The higher the score, the better the health status.
The association between the score of each domain of WhoQol-BREF and PA/sedentary profile will be explored.
Measured: Year 1
Correlation of PA and sedentary measures and quality of life (QOL) of patients
Quality of life will be assessed with the World Health Organization Quality of Life Instruments (WhoQol-BREF) questionnaire, which has 26 items, divided into 4 domains: physical health, psychological, social relationship and environment. The score for each item ranges from 1 to 5. The score for each domain is calculated using a template designed by the WhoQol-BREF development team. The higher the score, the better the health status.
The association between the score of each domain of WhoQol-BREF and PA/sedentary profile will be explored.
Measured: Year 2
Correlation of PA and sedentary measures and quality of life (QOL) of patients
Quality of life will be assessed with the World Health Organization Quality of Life Instruments (WhoQol-BREF) questionnaire, which has 26 items, divided into 4 domains: physical health, psychological, social relationship and environment. The score for each item ranges from 1 to 5. The score for each domain is calculated using a template designed by the WhoQol-BREF development team. The higher the score, the better the health status.
The association between the score of each domain of WhoQol-BREF and PA/sedentary profile will be explored.
Measured: year 3
Correlation of PA and sedentary measures and quality of life (QOL) of patients
Quality of life will be assessed with the World Health Organization Quality of Life Instruments (WhoQol-BREF) questionnaire, which has 26 items, divided into 4 domains: physical health, psychological, social relationship and environment. The score for each item ranges from 1 to 5. The score for each domain is calculated using a template designed by the WhoQol-BREF development team. The higher the score, the better the health status.
The association between the score of each domain of WhoQol-BREF and PA/sedentary profile will be explored.
Measured: Year 4
Occurrence of hospitalization and/or surgery of patients in each cohort
Patient hospitalization and/or surgery data are collected during follow-up (period of hospitalization, condition of hospitalization).
Measured: Year 1
Occurrence of hospitalization and/or surgery of patients in each cohort
Patient hospitalization and/or surgery data are collected during follow-up (period of hospitalization, condition of hospitalization).
Measured: Year 2
Occurrence of hospitalization and/or surgery of patients in each cohort
Patient hospitalization and/or surgery data are collected during follow-up (period of hospitalization, condition of hospitalization).
Measured: Year 3
Occurrence of hospitalization and/or surgery of patients in each cohort
Patient hospitalization and/or surgery data are collected during follow-up (period of hospitalization, condition of hospitalization).
Measured: Year 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start7 Dec 2023
- Primary completionDec 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExerciseStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne Tournadre, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05578495
- Sponsor's protocol ID
- RBHP 2021 TOURNADRE
- Other IDs
- 2021-A01967-34
- Acronym
- eMOB
- Status last verified
- Sep 2025
- First submitted
- 19 Sep 2022
- Last updated
- 24 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of a Digital Signature of Physical Activity and Sedentary Lifestyle With the Development of Multimorbidities Over 4 Years of Follow-up in Chronic Diseases (eMOB) : a Prospective Cohort
- ClinicalTrials.gov ID
- NCT05578495
- Acronym / sponsor ID
- eMOB / RBHP 2021 TOURNADRE
- Conditions
- Exercise, Sedentary Behavior, Non Communicable Diseases, Comorbidities and Coexisting Conditions, Comorbidity, Multimorbidity
- Keywords
- Physical Activity, Sedentary Lifestyle, Chronic Diseases, Comorbidities, Multimorbidity, Personal digital health, Personalized medecine
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 7 Dec 2023 (actual)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 13 Oct 2022 (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.
Physical activity (PA) and sedentary lifestyle are determinants in the development of chronic diseases and associated quality of life alterations. PA levels are correlated with quality of life and morbidity in chronic lung disease (COPD), cardiovascular disease, diabetes, cancer, chronic inflammatory rheumatism, fibromyalgia and anxiety disorders. In these diseases, low-intensity PA often represents the main PA and the quantity of PA is correlated with health parameters.
This study aims to identify a typical profile (signature) in relation to the appearance of other chronic diseases, complications of your disease, from recording your physical activity and sedentary lifestyle by sensors evaluating very precisely the movements and taking into account the characteristics and disability related to your disease. The results of this study would therefore make it possible to identify this signature even before the appearance of complications or other diseases.
Detailed description
Study design :
eMOB study is a monocentric prospective cohort study. We aim to explore in a longitudinal study the association of a digital signature of PA and sedentary lifestyle with the development of at least one additionnal comorbidity overs 4 years of follow-up in chronic diseases.
Population :
Patients with inflammatory rheumatic disease(rheumatoid arthritis and spondyloarthritis), pre-surgical knee and hip osteoarthritis, major depressive disorder and bipolar disorder, type 2 diabetes, obesity, COPD and chronic pain followed up in the observational cohorts specific to each pathology at the CHU of Clermont Ferrand, will be proposed to participate in the study during their follow-up visit.
Method :
The occurrence of comorbidity is monitored every year during follow-up visits of the patients. Physical activity and sedentary lifestyle is assessed using accelerometer and wearable sensors. The combination of quantitative analysis of movement with a more detailed analysis of movement and sequences of movements, and a personalization of the algorithm according to the disease and the context, could make it possible to establish predictive signatures either of the disease itself or of associated complications.
700 patients will be included in the study.They will be followed for 4 years with :
- An annual visit during which :
- clinical data in the routine follow-up will be collected (BMI, waist circumference, blood pressure, heart rate, comorbidities, activity and severity scores specific to each disease and used for the routine follow-up, treatments, lifestyle, family and socio-professional situation, education level)
- comorbidities will be noted by the list used for the study
- physical capacity will be assessed with the 6-minute walk test and the hand grip
- questionnaires about Pain (QCD), Fatigue (FACIT-F), Anxiety and Depression (HADs), Quality of life (WhoQol-BREF), Poverty (EPICES), Physical activity questionnaire (RPAQ), Barriers and Facilitators to physical activity questionnaire (B\&F-AP), Sleep and daytime sleepiness (PSQI and Epworth), treatment compliance (MARS) will be completed
- specific data for each pathology in each cohort will be collected
- Accelerometer data 3 times a year for 5 days (3 weekdays and 2 weekend days) will be collected
- Electronic patient report outcomes (e-PRO) every 4 months concerning the socio-professional situation of the patients, alcohol and tobacco consumption, skipping meals and snacking between meals, health problems they may encounter during the study. Numerical scales between 0 and 10 will be completed to assess disease status, health status, pain, sleep, fatigue, psychological well-being, and anxiety.
Among the included patients, 10 patients per cohort will participate in the preliminary feasibility phase of the study before starting the follow-up in the study. It is a validation of the acquisition modalities of the pre-selected sensors and a calibration on representative samples of patients with the different chronic pathologies studied (locomotor, respiratory, metabolic, psychiatric, pain).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic diseases | Other | Other: Accelerometer dataCohort Study |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patient follow-up at CHU Clermont-Ferrand for a chronic disease in one of the following observational cohorts:
- Affiliation to a social security system.
- Able to provide written informed consent to participate in the research.
Key exclusion criteria (4 listed)
- Inability to practice physical activity
- Pregnant or breastfeeding
- Refusal to participate
- Minors or adults under the protection of the law or under the protection of justice.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Accelerometer dataPatients will wear an accelerometer 3 times a year for 5 days (3 weekdays and 2 weekend days), the data will be collected | Other | Chronic diseases |
Primary outcome
Occurrence of one additional comorbidity in patients with chronic diseases.
Time frame: year 4
Association of a digital signature of PA and sedentary lifestyle with the development of at least one additional comorbidity over 4 years of follow-up.
Digital signature of sedentary lifestyle and PA in patients with chronic diseases.
Time frame: Year 4
A sensor of movement will be worn by the patients for 5 days every 4 months during the study, to detect and quantify the physical activity and the sedentarity according to their intensity. This sensor will be accelerometer, allowing the acquisition of movements second by second. The analysis of the data from the sensors, the occurrence of a new comorbidity, the clinical data will allow to establish an algorithm to define a profile (digital signature) of occurrence of a new chronic disease.
20 secondary outcomes
Occurence of multimorbidity in patients with chronic diseases.
Time frame: Year 1
Occurence of multimorbidity in patients with chronic diseases.
Time frame: year 2
Occurence of multimorbidity in patients with chronic diseases.
Time frame: Year 3
Occurence of multimorbidity in patients with chronic diseases.
Time frame: Yaer 4
Correlation of PA/sedentary signature with destabilization or improvement/stability of the chronic condition.
Time frame: Year 1
Correlation of PA/sedentary signature with destabilization or improvement/stability of the chronic condition.
Time frame: Year 2
Correlation of PA/sedentary signature with destabilization or improvement/stability of the chronic condition.
Time frame: Year 3
Correlation of PA/sedentary signature with destabilization or improvement/stability of the chronic condition.
Time frame: Year 4
Correlation of PA/sendetary and treatments for chronic diseases.
Time frame: Year 1
Correlation of PA/sendetary and treatments for chronic diseases.
Time frame: year 2
Correlation of PA/sendetary and treatments for chronic diseases.
Time frame: Year 3
Correlation of PA/sendetary and treatments for chronic diseases.
Time frame: Year 4
Correlation of PA and sedentary measures and quality of life (QOL) of patients
Time frame: Year 1
Correlation of PA and sedentary measures and quality of life (QOL) of patients
Time frame: Year 2
Correlation of PA and sedentary measures and quality of life (QOL) of patients
Time frame: year 3
Correlation of PA and sedentary measures and quality of life (QOL) of patients
Time frame: Year 4
Occurrence of hospitalization and/or surgery of patients in each cohort
Time frame: Year 1
Occurrence of hospitalization and/or surgery of patients in each cohort
Time frame: Year 2
Occurrence of hospitalization and/or surgery of patients in each cohort
Time frame: Year 3
Occurrence of hospitalization and/or surgery of patients in each cohort
Time frame: Year 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2025.
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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.
Anne Tournadre principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Accelerometer data in people with Exercise and Sedentary Behavior, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 10 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 24 Sep 2025. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lise LACLAUTRE (+33473754963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of one additional comorbidity in patients with chronic diseases. (time frame: year 4). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Sep 2025.