Diabetes Mellitus Self Management EducationNCT06916871
Optimizing Care for Diabetic Patients in Hospitalized Rehabilitation Through Structured Education
A study testing The experimental group will benefit from structured education which will be carried out by the diabetes nurse in people with Diabetes Mellitus Self Management Education, run by Centre Hospitalier Universitaire de Liege at 1 site in Belgium.
Trial summary
A large number of patients at the Neurological and Functional Rehabilitation Centre of the University Hospital of Liège have associated pathologies, including diabetes. These patients may have diabetes-related complications that require recurrent hospitalizations in an acute structure or in rehabilitation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus Self Management Education
- What is being tested?
- The experimental group will benefit from structured education which will be carried out by the diabetes nurse
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 7 Apr 2025to 31 Oct 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient having given written consent.
- Diagnosis of diabetes notified in medical file.
- Be at least 18 years old.
- Be able to communicate orally and in writing.
- Have a sufficient understanding of the French language.
Who cannot join
- Presence of cognitive disorder, confusion, spatio-temporal disorientation noted in the nursing and/or medical file.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site
Centre Hospitalier Universitaire de Liège, site Centre Neurologique et de Réadaptation Fonctionnelle
Tinlot, Liège, 4557
Héléna Cassol, PhD, scientific coordinator, +32 4 323 62 38, hcassol@chuliege.be
About this study
Official title: Optimizing Care for Diabetic Patients in Hospitalized Rehabilitation Through Structured Education.
A large number of patients at the Neurological and Functional Rehabilitation Centre of the University Hospital of Liège have associated pathologies, including diabetes. These patients may have diabetes-related complications that require recurrent hospitalizations in an acute structure or in rehabilitation. One of the ways to limit complications is to set up patient education.
- Objectives
Read more
- To compare the impact of management through formal education with that of awareness.
- To evaluate the impact on knowledge of structured education.
- To evaluate the impact of structured education on the quality of life experienced by diabetic patients.
- Identify the patient's level of satisfaction with the education sessions.
- To evaluate the impact of structured education on the biological improvement of glycated hemoglobin.
- To evaluate the impact of structured education on diabetes-related complications.
- Working Hypothesis The implementation of structured diabetes education allows "patients to acquire, or maintain, the skills they need to manage their lives as well as possible despite the constraints of chronic disease... ".
- Study population All diabetic patients hospitalized in all care units.
- Collection tools and techniques Collection tools
- "Diabetes Knowledge Questionnaire". 2. SF-36 Health Questionnaire. 3. Satisfaction questionnaire for structured sessions on diabetes. 4. Questionnaire to identify complications and/or re-hospitalizations after your stay in rehabilitation.
Collection technology At admission (D+1)
- Validation of inclusion and exclusion criteria.
- Submission and distribution of the information and consent form.
- Obtaining informed consent from the patient.
- Distribution of collection tools 1 and 2 (collection on D+2).
- Control of glycated hemoglobin. At the end of hospitalization (D-2)
- Distribution of collection tools 1, 2 and 3 on D-2 before the release (collection on D-1).
- Control of glycated hemoglobin. 3 months after the end of hospitalization
- Sending collection tools 1, 2 and 4 by post. The patient will be invited to complete them and return them by post.
- The patient will be invited to take a blood test for glycated hemoglobin.
Read the detailed description
Introduction The World Health Organization (WHO) defines diabetes as "a chronic disease that occurs when the pancreas does not produce enough insulin, or when the body is unable to use the insulin it produces effectively.
Type 1 diabetes (formerly called insulin-dependent or juvenile diabetes) is characterized by insufficient insulin production, which must be administered daily. In 2017, 9 million people had type 1 diabetes, most of them living in high-income countries. The cause of type 1 diabetes is not known, and it is not currently known how to prevent it.
Type 2 diabetes changes the way the body uses sugar (glucose) for energy. It prevents the body from using insulin properly, which can lead to high blood sugar levels if left untreated. Over time, type 2 diabetes can cause serious damage, especially to nerves and blood vessels. Type 2 diabetes can often be prevented. Factors that contribute to the development of type 2 diabetes include being overweight, not getting enough exercise, and having a genetic predisposition.
One of the most important ways to treat diabetes is to maintain a healthy lifestyle.
Some people with type 2 diabetes will need to take medication to control their blood sugar. This may include injected insulin or other medications, including: metformin, sulfonylureas, sodium-glucose cotransporter-2 inhibitors (SGLT-2 inhibitors). " According to the International Diabetes Federation (IDF), "The facts and figures about diabetes demonstrate the growing global burden it places on individuals, families, and countries. The IDF Diabetes Atlas (2021) indicates that 10.5% of the adult population (20-79 years) have diabetes and nearly half of them are unaware that they are living with the condition.
By 2045, IDF projections show that one in eight adults, or approximately 783 million people, will be living with diabetes, representing an increase of 46%.
More than 90% of people with diabetes have type 2 diabetes, which is due to socioeconomic, demographic, environmental and genetic factors. The main factors contributing to the increase in type 2 diabetes are:
- Urbanization.
- Ageing population.
- Decreased levels of physical activity.
- Increased prevalence of overweight and obesity. However, it is possible to reduce the impact of diabetes by taking preventive measures for type 2 diabetes and providing early diagnosis and appropriate care for all types of diabetes. These measures can help people with diabetes avoid or delay complications. " In Belgium in 2021, 6.8% of the Belgian population suffered from diabetes, which represents 798,912 people. 1/3 of people are not diagnosed with diabetes, which brings the prevalence of diabetes in Belgium to 10% (i.e. more than 1 million people).
Effective management of diabetic patients is therefore a real challenge and is of paramount importance at a time when government budgetary constraints are increasingly severe. The transfer of skills, the financing law and the new method of financing institutions have considerably impacted the financial resources of our hospitals.
How can it be done better with less? How can hospitalizations that are costly for society and their duration be limited within the framework of limited hospital funding?
- Problem A large number of patients at the Neurological and Functional Rehabilitation Center (CNRF) have associated pathologies, particularly diabetes. These patients may have complications related to diabetes that require recurring hospitalizations in an acute structure or in rehabilitation. One way to limit complications is to implement patient education.
"Patient education consists of nursing care aimed at facilitating the learning of knowledge, know-how and interpersonal skills in order to achieve a change in behavior in the patient, their family or a significant person." Before the implementation of this project, patient education consisted of awareness-raising according to the definition of the 2011 Minimum Hospital Summary Nursing Data Scoring Manual (DI-RHM) "Set of educational activities carried out with the aim of raising awareness, informing or enabling the acquisition of certain knowledge, abilities or skills with a view to regaining autonomy: information on the disease process, education in the management of prescribed medication, etc. These activities concern the patient, their family or any other person
- Being tested
- The control group will benefit from awareness, The experimental group will benefit from structured education which will be carried out by the diabetes nurse
- Keywords
- optimisation, autonomie, diabète, réadaptation, éducation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The control group will benefit from awarenessOther
During hospitalization in rehabilitation, doctors and nursing staff will transmit information in a linear manner, i.e. explain, possibly argue and answer the patient's questions on topics such as interpreting blood sugar levels, explaining treatment, good practices in terms of diet, physical activity, etc. at the patient's bedside in an unstructured manner based on interactions between patient and caregivers. There is therefore no standard frequency, number of specific sessions, or topics addressed systematically.
The experimental group will benefit from structured education which will be carried out by the diabetes nurseOther
During hospitalization in rehabilitation, the experimental group will benefit from structured education which will be carried out by the diabetes nurse at a rate of 3 sessions for patients on oral anti-diabetics and 5 sessions for patients on insulin.
| Study group | Role | What they receive |
|---|---|---|
| Awareness | Active comparator | The control group will benefit from awareness. Doctors and nursing staff will transmit information in a linear manner, i.e. explain, possibly argue and answer the patient's questions on topics such as interpreting blood sugar levels, explaining treatment, good practices in terms of diet, physical activity, etc. at the patient's bedside in an unstructured manner based on interactions between patient and caregivers. There is therefore no standard frequency, number of specific sessions, or topics addressed systematically. Receives: Other: The control group will benefit from awareness |
| Education | Experimental | The experimental group will benefit from structured education which will be carried out by the diabetes nurse at a rate of 3 sessions for patients on oral anti-diabetics and 5 sessions for patients on insulin. Receives: Other: The experimental group will benefit from structured education which will be carried out by the diabetes nurse |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diabete Knowledge Questionnaire.
The DKQ consists of 15 multiple-choice questions relating to the minimum knowledge about diabetes. Fourteen of the fifteen questions concern type 1 and type 2 diabetes. Question 15 relates only to type 1 diabetes. Demographic data, such as age, gender, duration of diabetes, as well as type of drug treatment, are collected by an additional 16th question consisting of nine items.
A score of 0 to 1 is assigned to each of the answers to the questions; For some questions, several answers must be checked. A score of 0 is assigned for an incorrect answer, 1 for a correct answer, and 0.5 for "unsure". For participants with type 2 diabetes who are not taking medication, the total possible score is a maximum of 26. It is 28 for people who take anti-diabetic medications. For participants with type 1 diabetes, the maximum possible score is 32.
Measured: From the day after the first day of hospitalization in rehabilitation to 3 months after the end of hospitalization.
Quality of life felt.
The SF-36 short-form questionnaire is used to obtain a generic measure of perceptual health status. Each question is scored with a Lickert with a minimum value of 0 and a maximum value of 100. The lowest values indicate a poorer perceived quality of life and the higher values indicate a better quality of life.
Measured: From the day after the first day of hospitalization in rehabilitation to 3 months after the end of hospitalization.
Secondary outcomes (3)
Patient's level of satisfaction.
Patient's level of satisfaction with the structured education program is rated on a scale from 0 (worst/lowest satisfaction status) to 10 (highest satisfaction status).
Measured: Two days before the end of hospitalization.
Improvement of glycated hemoglobin.
A significant decrease (p < 0.05) in the patient's glycated hemoglobin value is expected.
Measured: From the day after the first day of hospitalization in rehabilitation to 3 months after the end of hospitalization.
Diabetes-related complications.
Follow-up of diabetes-related complications: number of consultations with the general practitioner, number of consultations with the diabetic nurse and number of hospitalizations.
Measured: 3 months after the end of hospitalization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2025
- Study start7 Apr 2025 (estimated)
- Primary completion7 Apr 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Self Management EducationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Helena Cassol, Centre Hospitalier Universitaire de Liege
- Investigators
- Théodora Giagoultsis, Head nurse, Principal investigator, Centre Hospitalier Universitaire de LiegeJustine Slomian, scientist, Principal investigator, Centre Hospitalier Universitaire de LiegeNadia Jaajouai, Principal investigator, Centre Hospitalier Universitaire de Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06916871
- Sponsor's protocol ID
- 2024-416
- Status last verified
- Apr 2025
- First submitted
- 11 Feb 2025
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Care for Diabetic Patients in Hospitalized Rehabilitation Through Structured Education.
- ClinicalTrials.gov ID
- NCT06916871
- Acronym / sponsor ID
- 2024-416
- Keywords
- optimisation, autonomie, diabète, réadaptation, éducation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de LiegeUniversity, hospital or other
- Study start
- 7 Apr 2025 (estimated)
- Primary completion
- 7 Apr 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 8 Apr 2025 (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.
A large number of patients at the Neurological and Functional Rehabilitation Centre of the University Hospital of Liège have associated pathologies, including diabetes. These patients may have diabetes-related complications that require recurrent hospitalizations in an acute structure or in rehabilitation. One of the ways to limit complications is to set up patient education.
- Objectives
- To compare the impact of management through formal education with that of awareness.
- To evaluate the impact on knowledge of structured education.
- To evaluate the impact of structured education on the quality of life experienced by diabetic patients.
- Identify the patient's level of satisfaction with the education sessions.
- To evaluate the impact of structured education on the biological improvement of glycated hemoglobin.
- To evaluate the impact of structured education on diabetes-related complications.
- Working Hypothesis The implementation of structured diabetes education allows "patients to acquire, or maintain, the skills they need to manage their lives as well as possible despite the constraints of chronic disease... ".
- Study population All diabetic patients hospitalized in all care units.
- Collection tools and techniques Collection tools
- "Diabetes Knowledge Questionnaire". 2. SF-36 Health Questionnaire. 3. Satisfaction questionnaire for structured sessions on diabetes. 4. Questionnaire to identify complications and/or re-hospitalizations after your stay in rehabilitation.
Collection technology At admission (D+1)
- Validation of inclusion and exclusion criteria.
- Submission and distribution of the information and consent form.
- Obtaining informed consent from the patient.
- Distribution of collection tools 1 and 2 (collection on D+2).
- Control of glycated hemoglobin. At the end of hospitalization (D-2)
- Distribution of collection tools 1, 2 and 3 on D-2 before the release (collection on D-1).
- Control of glycated hemoglobin. 3 months after the end of hospitalization
- Sending collection tools 1, 2 and 4 by post. The patient will be invited to complete them and return them by post.
- The patient will be invited to take a blood test for glycated hemoglobin.
Detailed description
Introduction The World Health Organization (WHO) defines diabetes as "a chronic disease that occurs when the pancreas does not produce enough insulin, or when the body is unable to use the insulin it produces effectively.
Type 1 diabetes (formerly called insulin-dependent or juvenile diabetes) is characterized by insufficient insulin production, which must be administered daily. In 2017, 9 million people had type 1 diabetes, most of them living in high-income countries. The cause of type 1 diabetes is not known, and it is not currently known how to prevent it.
Type 2 diabetes changes the way the body uses sugar (glucose) for energy. It prevents the body from using insulin properly, which can lead to high blood sugar levels if left untreated. Over time, type 2 diabetes can cause serious damage, especially to nerves and blood vessels. Type 2 diabetes can often be prevented. Factors that contribute to the development of type 2 diabetes include being overweight, not getting enough exercise, and having a genetic predisposition.
One of the most important ways to treat diabetes is to maintain a healthy lifestyle.
Some people with type 2 diabetes will need to take medication to control their blood sugar. This may include injected insulin or other medications, including: metformin, sulfonylureas, sodium-glucose cotransporter-2 inhibitors (SGLT-2 inhibitors). " According to the International Diabetes Federation (IDF), "The facts and figures about diabetes demonstrate the growing global burden it places on individuals, families, and countries. The IDF Diabetes Atlas (2021) indicates that 10.5% of the adult population (20-79 years) have diabetes and nearly half of them are unaware that they are living with the condition.
By 2045, IDF projections show that one in eight adults, or approximately 783 million people, will be living with diabetes, representing an increase of 46%.
More than 90% of people with diabetes have type 2 diabetes, which is due to socioeconomic, demographic, environmental and genetic factors. The main factors contributing to the increase in type 2 diabetes are:
- Urbanization.
- Ageing population.
- Decreased levels of physical activity.
- Increased prevalence of overweight and obesity. However, it is possible to reduce the impact of diabetes by taking preventive measures for type 2 diabetes and providing early diagnosis and appropriate care for all types of diabetes. These measures can help people with diabetes avoid or delay complications. " In Belgium in 2021, 6.8% of the Belgian population suffered from diabetes, which represents 798,912 people. 1/3 of people are not diagnosed with diabetes, which brings the prevalence of diabetes in Belgium to 10% (i.e. more than 1 million people).
Effective management of diabetic patients is therefore a real challenge and is of paramount importance at a time when government budgetary constraints are increasingly severe. The transfer of skills, the financing law and the new method of financing institutions have considerably impacted the financial resources of our hospitals.
How can it be done better with less? How can hospitalizations that are costly for society and their duration be limited within the framework of limited hospital funding?
- Problem A large number of patients at the Neurological and Functional Rehabilitation Center (CNRF) have associated pathologies, particularly diabetes. These patients may have complications related to diabetes that require recurring hospitalizations in an acute structure or in rehabilitation. One way to limit complications is to implement patient education.
"Patient education consists of nursing care aimed at facilitating the learning of knowledge, know-how and interpersonal skills in order to achieve a change in behavior in the patient, their family or a significant person." Before the implementation of this project, patient education consisted of awareness-raising according to the definition of the 2011 Minimum Hospital Summary Nursing Data Scoring Manual (DI-RHM) "Set of educational activities carried out with the aim of raising awareness, informing or enabling the acquisition of certain knowledge, abilities or skills with a view to regaining autonomy: information on the disease process, education in the management of prescribed medication, etc. These activities concern the patient, their family or any other person
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Awareness | Active comparator | Other: The control group will benefit from awarenessThe control group will benefit from awareness. Doctors and nursing staff will transmit information in a linear manner, i.e. explain, possibly argue and answer the patient's questions on topics such as interpreting blood sugar levels, explaining treatment, good practices in terms of diet, physical activity, etc. at the patient's bedside in an unstructured manner based on interactions between patient and caregivers. There is therefore no standard frequency, number of specific sessions, or topics addressed systematically. |
| Education | Experimental | Other: The experimental group will benefit from structured education which will be carried out by the diabetes nurseThe experimental group will benefit from structured education which will be carried out by the diabetes nurse at a rate of 3 sessions for patients on oral anti-diabetics and 5 sessions for patients on insulin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient having given written consent.
- Diagnosis of diabetes notified in medical file.
- Be at least 18 years old.
- Be able to communicate orally and in writing.
- Have a sufficient understanding of the French language.
Key exclusion criteria (1 listed)
- Presence of cognitive disorder, confusion, spatio-temporal disorientation noted in the nursing and/or medical file.
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 |
|---|---|---|
| The control group will benefit from awarenessDuring hospitalization in rehabilitation, doctors and nursing staff will transmit information in a linear manner, i.e. explain, possibly argue and answer the patient's questions on topics such as interpreting blood sugar levels, explaining treatment, good practices in terms of diet, physical activity, etc. at the patient's bedside in an unstructured manner based on interactions between patient and caregivers. There is therefore no standard frequency, number of specific sessions, or topics addressed systematically. | Other | Awareness |
| The experimental group will benefit from structured education which will be carried out by the diabetes nurseDuring hospitalization in rehabilitation, the experimental group will benefit from structured education which will be carried out by the diabetes nurse at a rate of 3 sessions for patients on oral anti-diabetics and 5 sessions for patients on insulin. | Other | Education |
Primary outcome
Diabete Knowledge Questionnaire.
Time frame: From the day after the first day of hospitalization in rehabilitation to 3 months after the end of hospitalization.
The DKQ consists of 15 multiple-choice questions relating to the minimum knowledge about diabetes. Fourteen of the fifteen questions concern type 1 and type 2 diabetes. Question 15 relates only to type 1 diabetes. Demographic data, such as age, gender, duration of diabetes, as well as type of drug treatment, are collected by an additional 16th question consisting of nine items. A score of 0 to 1 is assigned to each of the answers to the questions; For some questions, several answers must be checked. A score of 0 is assigned for an incorrect answer, 1 for a correct answer, and 0.5 for "unsure". For participants with type 2 diabetes who are not taking medication, the total possible score is a maximum of 26. It is 28 for people who take anti-diabetic medications. For participants with type 1 diabetes, the maximum possible score is 32.
Quality of life felt.
Time frame: From the day after the first day of hospitalization in rehabilitation to 3 months after the end of hospitalization.
The SF-36 short-form questionnaire is used to obtain a generic measure of perceptual health status. Each question is scored with a Lickert with a minimum value of 0 and a maximum value of 100. The lowest values indicate a poorer perceived quality of life and the higher values indicate a better quality of life.
3 secondary outcomes
Patient's level of satisfaction.
Time frame: Two days before the end of hospitalization.
Improvement of glycated hemoglobin.
Time frame: From the day after the first day of hospitalization in rehabilitation to 3 months after the end of hospitalization.
Diabetes-related complications.
Time frame: 3 months after the end of hospitalization.
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 8 Apr 2025.
- Individual participant dataSharing planned: No
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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.
Théodora Giagoultsis, Head nurse principal investigator
Centre Hospitalier Universitaire de Liege
Justine Slomian, scientist principal investigator
Centre Hospitalier Universitaire de Liege
Nadia Jaajouai principal investigator
Centre Hospitalier Universitaire de Liege
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The experimental group will benefit from structured education which will be carried out by the diabetes nurse in people with Diabetes Mellitus Self Management Education, run by Centre Hospitalier Universitaire de Liege at 1 site in Belgium.
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 5 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: opening soon, as of the sponsor's last update on 8 Apr 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 Belgium. 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 Héléna Cassol, PhD (+32 475 47 41 28, hcassol@chuliege.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diabete Knowledge Questionnaire. (time frame: From the day after the first day of hospitalization in rehabilitation to 3 months after the end of hospitalization.). 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 8 Apr 2025.