Chronic Kidney DiseasesTelemechronNCT05906927

Telemedicine for Home-based Management of Patients With Chronic Kidney Diseases and Comorbidities (NET-2018-12367206)

An observational study of Chronic Kidney Diseases, run by Azienda USL Toscana Nord Ovest at 1 site in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Any age
Conditions the study is for: Chronic Kidney Diseases
How many people: 8 participants
Where: 1 siteItaly
Study dates: 1 Aug 2022to 30 Sep 2024
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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: We propose to consider 3 case studies: 2 patients on peritoneal dialysis , 2 patients on home hemodialysis and 4 patients attending pre-dialysis clinic .

Who may be able to join

patients already on treatment both in continuous home peritoneal dialysis (CAPD) and patients in nocturnal automated peritoneal dialysis (IPD)
autonomous in their management of dialysis therapy,
absence of acute or rapidly disabling comorbidities,
ability to use a smart phone,
home covered by fast optical fiber
Patients already in treatment, autonomous in their management of home dialysis therapy, or in dialysis at peripheral centers where the continuous presence of the nephrologist is not guaranteed

Show all 15Show fewer

Absence of acute or rapidly disabling comorbidities,
Presence of a stable and well-functioning vascular access for hemodialysis,
Ability to use a smart phone,
Home covered by fast optical fiber
Inclusion Criteria for Chronic nephropathic patients undergoing predialysis:
Patients already taken care of by the facility,
Absence of acute or rapidly disabling comorbidities,
Ability to use a smart phone,
Home covered by fast optical fiber

Who cannot join

History of malignant hypertension or accelerated hypertension within 6 months prior to study entry.
History of drugs i.v. or alcohol abuse. History of cocaine abuse will be an exclusion criterion.
Serious systemic disease that could affect the survival or course of the kidney disease.
Body mass index greater than 35 Kg/m2 in men and 33 Kg/m2 in women. BMI is calculated as weight (kg)/height (m2).
Myocardial infarction or cerebrovascular accident in the past 6 months
Pregnancy or likelihood of becoming pregnant during the study period.
Using nonsteroidal anti-inflammatory drugs (NSAIDs) for more than 1 week/month, excluding baby aspirin.
Suspect that the participant will not be able to meet the protocol visits schedule.

Trial locations and contacts

1 site in 1 country.

Italy1 site

Azienda Sanitaria NordOvest Toscana
Livorno, Tuscany, 57100

Other trials in Italy

About this study

Official title: Telemedicine for Home-based Management of Patients With Chronic Kidney Diseases and Comorbidities: Analysis of Current Models and Design of Innovative Strategies to Improve Quality of Care and Optimise Resource Utilization

This project is aimed to analyze the current models and to design innovative strategies to improve quality of care and optimise resource utilization of telemedicine (TM) in home-based management for the global care of patients with chronic kidney diseases (CKD). The main focus is on the prevention of complications, recurrence of unstabilization and optimal therapy for the global management of chronic pts through TM and e-Health. Reducing avoidable/unnecessary hospitalisation of pts with chronic conditions, through the effective implementation of a health care network, offering integrated care programs and applying chronic disease management models, should ultimately contribute to the improved efficiency of health systems.

Read the detailed description

The investigators will design, test and evaluate innovative models for applying TM to the management of pts with chronic kidney diseases .

New models will be characterized by the followings:

flexible adaptation to pts subgroups/ individual pts characteristics, including pts (and caregivers) expectation and willingness to participate actively in the process of care
identification of technical components which are essential, accessory, useful or futile for different pts subgroups, including evaluation of pts abilities and preferences.
definition of the team of care and the roles and responsibilities of each components: case manager, clinical manager etc
pre-definition of outcome measures, that should include at least the evaluation of quality of life, perceived quality of care by the pts and caregivers, number and duration of hospitalizations.
definition of Quality Assurance (QA) derived indicators related to risk and performance of TM implementation where needed

Finally, the investigators will collect a set of data allowing to analyse and validate the care model and to measure the patient adherence to the care plan as well as measure the performance of the predictive models based on this data.

Conditions: Chronic Kidney Diseases
Medical subject headings: Renal Insufficiency, Chronic

What is being measured

The primary outcome is the main question the study is designed to answer.

Change from baseline number of days of hospitalization at 6 and 12 months
A comparison among the baseline number of days of hospitalization and the ones at 6 and 12 months will be performed. Data will be extracted from the data flows of healthcare information systems
Measured: Baseline, 6 months and 12 months
Change from baseline number of home visits by the doctor at 6 and 12 months
A comparison among the baseline number of home visits by the doctor and the ones at 6 and 12 months will be performed. Data will be extracted from the data flows of healthcare information systems
Measured: Baseline, 6 months and 12 months
Change from baseline number of doctor's office visits at 6 and 12 months
A comparison among the baseline number of doctor's office visits and the ones at 6 and 12 months will be performed. Data will be extracted from the data flows of healthcare information systems
Measured: Baseline, 6 months and 12 months
Change from Baseline number of nephrologist's office visits at 6 and 12 months
A comparison among the baseline number of nephrologist's office visits and the ones at 6 and 12 months will be performed. Data will be extracted from the data flows of healthcare information systems
Measured: Baseline, 6 months and 12 months
Change from baseline Dialyzer clearance of urea multiplied by dialysis time and normalized for urea distribution volume (Kt/V) at 6 and 12 months
A comparison among the baseline Kt/V and the one at 6 and 12 months will be performed. Data will be extracted from the Tests Laboratory data flows
Measured: Baseline, 6 months and 12 months
Change from baseline Estimated Glomerular Filtration Rate (eGFR) at 6 and 12 months
A comparison among the baseline eGFR and the one at 6 and 12 months will be performed. Data will be extracted from the Tests Laboratory data flows
Measured: Baseline, 6 months and 12 months
Change from baseline Hb at 6 and 12 months
A comparison among the baseline Hb and the one at 6 and 12 months will be performed. Data will be extracted from the Tests Laboratory data flows
Measured: Baseline, 6 months and 12 months
Change from baseline Ca/P at 6 and 12 months
A comparison among the baseline Ca/P and the one at 6 and 12 months will be performed. Data will be extracted from the Tests Laboratory data flows
Measured: Baseline, 6 months and 12 months
Change from baseline Parathyroid hormone (PTH) levels at 6 and 12 months
A comparison among the baseline PTH and the one at 6 and 12 months will be performed. Data will be extracted from the Tests Laboratory data flows
Measured: Baseline, 6 months and 12 months
Change from baseline Average weight loss in HD/PD at 6 and 12 months
A comparison among the baseline Average weight loss in HD/PD and the one at 6 and 12 months will be performed. Data will be extracted from the patients' clinical health record
Measured: Baseline, 6 months and 12 months
Change from baseline Weight at 6 and 12 months
A comparison among the baseline Weight and the one at 6 and 12 months will be performed. Data will be extracted from the patients' clinical health record
Measured: Baseline, 6 months and 12 months
Change from baseline HD complications at 6 and 12 months
A comparison among the baseline Intratreatment and Extra treatment HD complications and the ones at 6 and 12 months will be performed. Data will be extracted from the patients' clinical health record
Measured: Baseline, 6 months and 12 months
Change from baseline PD complications at 6 and 12 months
A comparison among the baseline Intratreatment and Extra treatment HD complications and the ones at 6 and 12 months will be performed. Data will be extracted from the patients' clinical health record
Measured: Baseline, 6 months and 12 months
Change from baseline Total number of prescribed drugs at 6 and 12 months
A comparison among the baseline Total number of prescribed drugs and the one at 6 and 12 months will be performed. Data will be extracted from the patients' clinical health record
Measured: Baseline, 6 months and 12 months
Change from 6 months Satisfaction score of the system at 12 months (5-level scale)
A comparison between the overall satisfaction rating of the system at 6 and 12 months will be carried out.
A 5-level scale is used (interval scale: 1 to 5): 1=Very Unsatisfied, 2= Unsatisfied, 3=Neutral, 4=Satisfied, 5=Very Satisfied.
Information collected through a specific questionnaire.
Measured: 6 months and 12 months
Change from 6 months Usability index of the system at 12 months
A comparison between the Usability rating of the whole system and of the individual devices at 6 and 12 months will be carried out. Information collected through a specific questionnaire.
Measured: 6 months and 12 months
Change from 6 months Time acceptability index at 12 months
A comparison between the Patients' acceptance of the time required for the system daily usage at 6 and 12 months will be carried out. Information collected through a specific questionnaire.
Measured: 6 months and 12 months
Change from 6 months Acceptance of a potential systematic usage at 12 months
A comparison between the Patients' acceptance of a potential systematic usage of the system at 6 and 12 months will be carried out. Information collected through a specific questionnaire.
Measured: 6 months and 12 months
Total number of measurements (systolic blood pressure, pulse rate, oxygen saturation, temperature, weight, electrocardiogram, bio-electrical impedance analysis)
Total number of measurements (systolic blood pressure, pulse rate, oxygen saturation, temperature, weight, electrocardiogram, bio-electrical impedance analysis) performed by patients through the devices he is equipped with.
Data will extracted from the system service platform.
Measured: 12 months
Total number of measurements (systolic blood pressure, pulse rate, oxygen saturation, temperature, weight, electrocardiogram, bio-electrical impedance analysis) per patient
Total number of measurements performed by each patient through the devices he is equipped with.
The measurements include the following parameters: systolic blood pressure, pulse rate, oxygen saturation, temperature, weight, electrocardiogram, bio-electrical impedance analysis parameters.
Data will extracted from the system service platform.
Measured: 12 months
Total number of measurements per parameter (systolic blood pressure, pulse rate, oxygen saturation, temperature, weight, electrocardiogram, bio-electrical impedance analysis)
Total number of measurements per parameter (systolic blood pressure, pulse rate, oxygen saturation, temperature, weight, electrocardiogram, bio-electrical impedance analysis) performed by patients through the devices he is equipped with.
Data will extracted from the system service platform.
Measured: 12 months
Total number of measurements per parameter (systolic blood pressure, pulse rate, oxygen saturation, temperature, weight, electrocardiogram, bio-electrical impedance analysis) per patient
Total number of measurements per parameter (systolic blood pressure, pulse rate, oxygen saturation, temperature, weight, electrocardiogram, bio-electrical impedance analysis) performed by each patient through the devices he is equipped with.
Data will extracted from the system service platform.
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 202230 Sep 2024

First posted18 Jun 2023
Study start1 Aug 2022
Primary completion30 Aug 2024 (estimated)
Study completion30 Sep 2024 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Chronic Kidney DiseasesStudies 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: Cross-sectional
Enrolment: 8 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05906927
Sponsor's protocol ID: Telemechron WP1-40/2019
Acronym: Telemechron
Status last verified: Oct 2023
First submitted: 2 Mar 2023
Last updated: 26 Oct 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Young A, Orchanian-Cheff A, Chan CT, Wald R, Ong SW. Video-Based Telemedicine for Kidney Disease Care: A Scoping Review. Clin J Am Soc Nephrol. 2021 Dec;16(12):1813-1823. doi: 10.2215/CJN.06660521. Epub 2021 Dec 7.
PubMed 36630403
Lindeboom L, Lee S, Wieringa F, Groenendaal W, Basile C, van der Sande F, Kooman J. On the potential of wearable bioimpedance for longitudinal fluid monitoring in end-stage kidney disease. Nephrol Dial Transplant. 2022 Oct 19;37(11):2048-2054. doi: 10.1093/ndt/gfab025.
PubMed 33544863
Gc VS, Iglesias CP, Erdem S, Hassan L, Peek N, Manca A. Using discrete-choice experiments to elicit preferences for digital wearable health technology for self-management of chronic kidney disease. Int J Technol Assess Health Care. 2022 Oct 26;38(1):e77. doi: 10.1017/S0266462322003233.
PubMed 36286261

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Telemedicine for Home-based Management of Patients With Chronic Kidney Diseases and Comorbidities: Analysis of Current Models and Design of Innovative Strategies to Improve Quality of Care and Optimise Resource Utilization
ClinicalTrials.gov ID: NCT05906927
Acronym / sponsor ID: Telemechron / Telemechron WP1-40/2019
Conditions: Chronic Kidney Diseases
Study type: Observational
Recruitment status: Unknown status
Enrolment: 8 participants (actual)
Lead sponsor: Azienda USL Toscana Nord OvestUniversity, hospital or other
Study start: 1 Aug 2022 (actual)
Primary completion: 30 Aug 2024 (estimated)
Study completion: 30 Sep 2024 (estimated)
First posted: 18 Jun 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.

Detailed description

The investigators will design, test and evaluate innovative models for applying TM to the management of pts with chronic kidney diseases .

New models will be characterized by the followings:

flexible adaptation to pts subgroups/ individual pts characteristics, including pts (and caregivers) expectation and willingness to participate actively in the process of care
identification of technical components which are essential, accessory, useful or futile for different pts subgroups, including evaluation of pts abilities and preferences.
definition of the team of care and the roles and responsibilities of each components: case manager, clinical manager etc
pre-definition of outcome measures, that should include at least the evaluation of quality of life, perceived quality of care by the pts and caregivers, number and duration of hospitalizations.
definition of Quality Assurance (QA) derived indicators related to risk and performance of TM implementation where needed

Study design

Observational model: Cohort
Time perspective: Cross-sectional

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: We propose to consider 3 case studies: 2 patients on peritoneal dialysis , 2 patients on home hemodialysis and 4 patients attending pre-dialysis clinic .

Key inclusion criteria (15 listed)

patients already on treatment both in continuous home peritoneal dialysis (CAPD) and patients in nocturnal automated peritoneal dialysis (IPD)
autonomous in their management of dialysis therapy,
absence of acute or rapidly disabling comorbidities,
ability to use a smart phone,
home covered by fast optical fiber

Key exclusion criteria (8 listed)

History of malignant hypertension or accelerated hypertension within 6 months prior to study entry.
History of drugs i.v. or alcohol abuse. History of cocaine abuse will be an exclusion criterion.
Serious systemic disease that could affect the survival or course of the kidney disease.
Body mass index greater than 35 Kg/m2 in men and 33 Kg/m2 in women. BMI is calculated as weight (kg)/height (m2).
Myocardial infarction or cerebrovascular accident in the past 6 months

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

Change from baseline number of days of hospitalization at 6 and 12 months
Time frame: Baseline, 6 months and 12 months
A comparison among the baseline number of days of hospitalization and the ones at 6 and 12 months will be performed. Data will be extracted from the data flows of healthcare information systems
Change from baseline number of home visits by the doctor at 6 and 12 months
Time frame: Baseline, 6 months and 12 months
A comparison among the baseline number of home visits by the doctor and the ones at 6 and 12 months will be performed. Data will be extracted from the data flows of healthcare information systems
Change from baseline number of doctor's office visits at 6 and 12 months
Time frame: Baseline, 6 months and 12 months
A comparison among the baseline number of doctor's office visits and the ones at 6 and 12 months will be performed. Data will be extracted from the data flows of healthcare information systems
Change from Baseline number of nephrologist's office visits at 6 and 12 months
Time frame: Baseline, 6 months and 12 months
A comparison among the baseline number of nephrologist's office visits and the ones at 6 and 12 months will be performed. Data will be extracted from the data flows of healthcare information systems
Change from baseline Dialyzer clearance of urea multiplied by dialysis time and normalized for urea distribution volume (Kt/V) at 6 and 12 months
Time frame: Baseline, 6 months and 12 months
A comparison among the baseline Kt/V and the one at 6 and 12 months will be performed. Data will be extracted from the Tests Laboratory data flows
Change from baseline Estimated Glomerular Filtration Rate (eGFR) at 6 and 12 months
Time frame: Baseline, 6 months and 12 months
A comparison among the baseline eGFR and the one at 6 and 12 months will be performed. Data will be extracted from the Tests Laboratory data flows
Change from baseline Hb at 6 and 12 months
Time frame: Baseline, 6 months and 12 months
A comparison among the baseline Hb and the one at 6 and 12 months will be performed. Data will be extracted from the Tests Laboratory data flows
Change from baseline Ca/P at 6 and 12 months
Time frame: Baseline, 6 months and 12 months
A comparison among the baseline Ca/P and the one at 6 and 12 months will be performed. Data will be extracted from the Tests Laboratory data flows
Change from baseline Parathyroid hormone (PTH) levels at 6 and 12 months
Time frame: Baseline, 6 months and 12 months
A comparison among the baseline PTH and the one at 6 and 12 months will be performed. Data will be extracted from the Tests Laboratory data flows
Change from baseline Average weight loss in HD/PD at 6 and 12 months
Time frame: Baseline, 6 months and 12 months
A comparison among the baseline Average weight loss in HD/PD and the one at 6 and 12 months will be performed. Data will be extracted from the patients' clinical health record
Change from baseline Weight at 6 and 12 months
Time frame: Baseline, 6 months and 12 months
A comparison among the baseline Weight and the one at 6 and 12 months will be performed. Data will be extracted from the patients' clinical health record
Change from baseline HD complications at 6 and 12 months
Time frame: Baseline, 6 months and 12 months
A comparison among the baseline Intratreatment and Extra treatment HD complications and the ones at 6 and 12 months will be performed. Data will be extracted from the patients' clinical health record
Change from baseline PD complications at 6 and 12 months
Time frame: Baseline, 6 months and 12 months
A comparison among the baseline Intratreatment and Extra treatment HD complications and the ones at 6 and 12 months will be performed. Data will be extracted from the patients' clinical health record
Change from baseline Total number of prescribed drugs at 6 and 12 months
Time frame: Baseline, 6 months and 12 months
A comparison among the baseline Total number of prescribed drugs and the one at 6 and 12 months will be performed. Data will be extracted from the patients' clinical health record
Change from 6 months Satisfaction score of the system at 12 months (5-level scale)
Time frame: 6 months and 12 months
A comparison between the overall satisfaction rating of the system at 6 and 12 months will be carried out. A 5-level scale is used (interval scale: 1 to 5): 1=Very Unsatisfied, 2= Unsatisfied, 3=Neutral, 4=Satisfied, 5=Very Satisfied. Information collected through a specific questionnaire.
Change from 6 months Usability index of the system at 12 months
Time frame: 6 months and 12 months
A comparison between the Usability rating of the whole system and of the individual devices at 6 and 12 months will be carried out. Information collected through a specific questionnaire.
Change from 6 months Time acceptability index at 12 months
Time frame: 6 months and 12 months
A comparison between the Patients' acceptance of the time required for the system daily usage at 6 and 12 months will be carried out. Information collected through a specific questionnaire.
Change from 6 months Acceptance of a potential systematic usage at 12 months
Time frame: 6 months and 12 months
A comparison between the Patients' acceptance of a potential systematic usage of the system at 6 and 12 months will be carried out. Information collected through a specific questionnaire.
Total number of measurements (systolic blood pressure, pulse rate, oxygen saturation, temperature, weight, electrocardiogram, bio-electrical impedance analysis)
Time frame: 12 months
Total number of measurements (systolic blood pressure, pulse rate, oxygen saturation, temperature, weight, electrocardiogram, bio-electrical impedance analysis) performed by patients through the devices he is equipped with. Data will extracted from the system service platform.
Total number of measurements (systolic blood pressure, pulse rate, oxygen saturation, temperature, weight, electrocardiogram, bio-electrical impedance analysis) per patient
Time frame: 12 months
Total number of measurements performed by each patient through the devices he is equipped with. The measurements include the following parameters: systolic blood pressure, pulse rate, oxygen saturation, temperature, weight, electrocardiogram, bio-electrical impedance analysis parameters. Data will extracted from the system service platform.
Total number of measurements per parameter (systolic blood pressure, pulse rate, oxygen saturation, temperature, weight, electrocardiogram, bio-electrical impedance analysis)
Time frame: 12 months
Total number of measurements per parameter (systolic blood pressure, pulse rate, oxygen saturation, temperature, weight, electrocardiogram, bio-electrical impedance analysis) performed by patients through the devices he is equipped with. Data will extracted from the system service platform.
Total number of measurements per parameter (systolic blood pressure, pulse rate, oxygen saturation, temperature, weight, electrocardiogram, bio-electrical impedance analysis) per patient
Time frame: 12 months
Total number of measurements per parameter (systolic blood pressure, pulse rate, oxygen saturation, temperature, weight, electrocardiogram, bio-electrical impedance analysis) performed by each patient through the devices he is equipped with. Data will extracted from the system service platform.

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
Background: PubMed 36630403Young A, Orchanian-Cheff A, Chan CT, Wald R, Ong SW. Video-Based Telemedicine for Kidney Disease Care: A Scoping Review. Clin J Am Soc Nephrol. 2021 Dec;16(12):1813-1823. doi: 10.2215/CJN.06660521. Epub 2021 Dec 7.
Background: PubMed 33544863Lindeboom L, Lee S, Wieringa F, Groenendaal W, Basile C, van der Sande F, Kooman J. On the potential of wearable bioimpedance for longitudinal fluid monitoring in end-stage kidney disease. Nephrol Dial Transplant. 2022 Oct 19;37(11):2048-2054. doi: 10.1093/ndt/gfab025.
Background: PubMed 36286261Gc VS, Iglesias CP, Erdem S, Hassan L, Peek N, Manca A. Using discrete-choice experiments to elicit preferences for digital wearable health technology for self-management of chronic kidney disease. Int J Technol Assess Health Care. 2022 Oct 26;38(1):e77. doi: 10.1017/S0266462322003233.
Individual participant dataSharing planned: No

Related trials for Chronic Kidney Diseases

Active, not recruitingPhase 2
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End Stage Renal Disease
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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.

Stefano Bianchi, MD study chair

Azienda Sanitaria Nord Ovest Toscana Italy

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 Kidney Diseases, run by Azienda USL Toscana Nord Ovest at 1 site in Italy.

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 15 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 26 Oct 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 Italy. 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?

Results are not available in the source record.

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?

Change from baseline number of days of hospitalization at 6 and 12 months (time frame: Baseline, 6 months and 12 months). The study lists 22 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 NCT05906927, which also lists 3 linked publications.

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 26 Oct 2023.