Multiple SclerosisBeCoolNCT06248281
Be Cool: An Innovative and Holistic Psychoeducational Program for Multiple Sclerosis Individuals
An observational study of Multiple Sclerosis, run by University of Thessaly at 1 site in Greece.
Trial summary
This observational study aims to investigate the impact of an online psychoeducational program, combined with cooling therapy, nutrition, psychological intervention, and exercise, on the resilience, treatment adherence, symptom management, and quality of life of individuals with Multiple Sclerosis. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- combination of different rehabilitation strategies
- How many people
- 30 participants
- Where
- 1 siteGreece
- Study dates
- 1 Jun 2023to 28 Feb 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 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be recruited from the GMSS (https://gmss.gr/) based on specific inclusion and exclusion criteria.
Who may be able to join
- Participants must have been diagnosed with MS using the McDonald criteria, ensuring a standardized and validated diagnostic approach.
- Participants should have been relapse-free during the six months leading up to the study to avoid potential confounding factors.
- Participants must have no musculoskeletal impediment that could affect their ability to engage in the exercise component of the program.
- Participants must have a score on the Expanded Disability Status Scale (EDSS) ranging from 0 to 5.5, indicating ambulatory ability without the need for a cane for at least 100 meters.
- Participants should have a history of sensitivity to heat, as reported by their treating physician, justifying the need for cooling therapy as part of the hybrid program.
- Participants must not have used cooling therapy or participated in any form of exercise training for at least four months prior to their participation in the study.
- -
Who cannot join
- Previously diagnosed conditions known to impact physiological responses to heat exposure, including diabetes mellitus, hypertension, heart disease, or kidney disease.
- Use of medications to manage MS-related symptoms, such as antidepressants, psychostimulants, anticonvulsants, antispasmodics, and anticholinergic drugs.
- -
Trial locations and contacts
1 site in 1 country.
Greece1 site
Greek Multiple Sclerosis Society
Thessaloniki, Central Macedonia, 55132
About this study
Official title: Be Cool: An Innovative and Holistic Psychoeducational Program to Improve and Promote Care, Education and Quality of Life for Multiple Sclerosis Individuals
This observational study aims to investigate the impact of an online psychoeducational program, combined with cooling therapy, nutrition, psychological intervention, and exercise, on the resilience, treatment adherence, symptom management, and quality of life of individuals with Multiple Sclerosis. The study will last for six months, during which two groups of 15 participants with similar characteristics and a diagnosis of Multiple Sclerosis will take part in the protocol. Group A will follow the research protocol, while Group B, the Control group, will not participate in any rehabilitation intervention.
Read the detailed description
Fifteen individuals with multiple sclerosis will participate in an innovative, hybrid rehabilitation program, encompassing several key components to enhance their well-being. The program includes:
- Exercise Intervention: Participants will engage in specially designed exercise programs. Every two weeks, they will meet virtually with an exercise physiologist via Microsoft Teams for tailored education about their specific needs. Additionally, a customized exercise video will be uploaded weekly to the Teams platform, ensuring ongoing physical engagement.
- Nutritional Evaluation and Education: Nutrition is a core focus. A nutritionist will meet with the participants bi-weekly to discuss their dietary needs and educate them on maintaining a balanced diet to support their condition. Further enhancing this aspect, a nutritious recipe will be uploaded to the platform each week, offering practical dietary guidance.
- Psychological Support: Psychological well-being is addressed through weekly group meetings conducted by a psychologist. These sessions will utilize Acceptance and Commitment Therapy (ACT) strategies to help participants manage their symptoms, accept their condition, and improve their overall quality of life.
- Head and Neck Cooling Strategy: Recognizing the importance of temperature regulation in MS, participants will be advised to apply a cooling strategy to the head and neck area for at least two hours daily, providing symptomatic relief.
To monitor progress and adjust the program as needed, participants' functional ability, nutritional status, psychological condition, and overall quality of life will be evaluated at three key points: baseline (before starting the program), at the three-month mark, and upon completion of the program at six months.
This program is structured to provide a holistic, supportive, and adaptable approach to managing multiple sclerosis, focusing on physical health, nutritional balance, psychological support, and practical strategies for daily living.
- Conditions
- Multiple Sclerosis
- Being tested
- combination of different rehabilitation strategies
- Keywords
- symptom management, hybrid program, rehabilitation, quality of life, psychoeducational program
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combination of different rehabilitation strategiesOther
Also called cooling therapy, diet, phycology-behavioral-mindfulness intervention, exercise traiining
The psychoeducational program will be conducted through weekly online video-conferencing group sessions that will last for two hours. In addition to these sessions, participants will receive psychoeducational material such as readings, videos, podcasts, worksheets, and homework exercises every week. This material will allow participants to practice at their own pace during the session intervals.
The exercise training program for individuals with MS will be tailored to meet the unique and individual needs of each participant. To achieve this, a head and neck cooling protocol will be implemented using commercially available cooling equipment, specifically the Headcool Power and Neckcool Tie from Inuteq. Participants will need to wear the cooling cup and neck wrap for two hours daily. The equipment will be activated using 10°C tap water. Finally, a nutritionist will provide personalized nutritional guidance including weekly diet observation and recipe videos.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | The experimental group will attend a structured psychoeducational program developed to build and promote psychological flexibility. In combination with this, participants of this group will have to follow a head and neck cooling protocol. Also, participants of this group will be required to increase their habitual exercise levels and follow a video exercise program specifically designed for their needs and improve their nutrition based on the instructions of a nutritionist and videos specially designed for them. Receives: Other: combination of different rehabilitation strategies | |
| Control group | As per the study plan, the Control group has been designated as the control group. They will continue with their normal lifestyle without any participation in rehabilitation activities or programs. Receives: Other: combination of different rehabilitation strategies |
What is being measured
The primary outcome is the main question the study is designed to answer.
anxiety and depression
This will be estimated with the "The Hospital Anxiety and Depression Scale - HADS". The Hospital Anxiety and Depression Scale (HADS) is a widely used questionnaire specifically designed to identify and measure the levels of anxiety and depression in individuals. It is particularly useful in medical settings, as it helps distinguish between psychological distress and physical illness.
Measured: Baseline, after three months and at the end of the six months
Overall quality of life, namely satisfaction with their life
This will be estimated with the questionnaire of Multiple Sclerosis Quality of Life-54 (MSQOL-54)
Measured: Baseline, after three months and at the end of the six months
Perception of stress
Perceived Stress Scale (PSS) will be used. This is a widely used psychological instrument for measuring the perception of stress. It assesses the degree to which situations in one's life are appraised as stressful. Items on the PSS ask about feelings and thoughts during the last month, and scores on the PSS can range from 0 to 40, with higher scores indicating higher perceived stress.
Measured: Baseline, after three months and at the end of the six months
Cognitive fusion which refers to the degree to which an individual's thoughts and feelings are intertwined with their sense of self, often leading to an inability to separate from, or 'defuse' from, these internal experiences.
The Cognitive Fusion Questionnaire (CFQ-7) questionnaire that measures cognitive fusion, which a key concept in Acceptance and Commitment Therapy (ACT) will be used. The CFQ-7, with its 7 items, assesses the extent to which a person experiences this phenomenon.
Measured: Baseline, after three months and at the end of the six months
The value of living
The Valued Living Questionnaire (VLQ) will be used. The VLQ is designed to assess valued living, which is another core concept in ACT. It helps individuals to identify what is truly important and meaningful to them in various domains of life (such as family, career, health) and to what extent they have been living in accordance with these values.
Measured: Baseline, after three months and at the end of the six months
Psychological flexibility which is the ability to be in the present moment with full awareness and openness to experiences, and to take action guided by one's values.
The MPFI-Psychological Flexibility Subscale will be used. This subscale is part of a larger questionnaire and specifically measures psychological flexibility, an essential aspect of mental health and well-being.
Measured: Baseline, after three months and at the end of the six months
The resilience which is defined as the ability to cope with and bounce back from adversity.
The Connor-Davidson Resilience Scale (CDRISC-25) will be used. This 25-item scale measures resilience, defined as the ability to cope with and bounce back from adversity. Higher scores indicate greater resilience.
Measured: Baseline, after three months and at the end of the six months
Aerobic capacity and ability to walk
The Two Minute Walk Test (2MWT) is a simple, easy-to-administer functional exercise test used primarily in clinical settings. It measures the distance an individual is able to walk on a flat, hard surface in a period of two minutes.
Measured: Baseline, after three months and at the end of the six months
Lower body strength and functional mobility
The Five Times Sit to Stand Test (5xSST) will be used which is a simple yet effective physical performance test used primarily to assess lower body strength and functional mobility. The test involves timing how long it takes an individual to stand up and sit down five times as quickly as possible from a standard height chair without using their arms for support. A longer time to complete the test generally indicates lower functional performance.
Measured: Baseline, after three months and at the end of the six months
Static and dynamic balance ability
The Berg Balance Scale (BBS) will be used which is a widely used clinical test of a person's static and dynamic balance abilities. It is particularly common in elderly populations and among those recovering from injury or dealing with conditions that affect balance.
Measured: Baseline, after three months and at the end of the six months
Mobility and walking speed
The Timed 25-Foot Walk (T25-FW) will be used which is a functional test commonly used to assess mobility and walking speed in individuals, particularly those with neurological conditions such as multiple sclerosis (MS).The test involves timing how quickly a person can walk 25 feet at their usual pace, usually conducted along a flat, straight course.
Measured: Baseline, after three months and at the end of the six months
Secondary outcomes (4)
Finger dexterity and arm-hand coordination
The 9-Hole Peg Test (9-HPT) will be used which is a standardized, widely used assessment tool in clinical and research settings to measure finger dexterity and arm-hand coordination. It's particularly useful for evaluating upper extremity function in individuals with neurological conditions, such as multiple sclerosis (MS) and stroke.
Measured: Baseline, after three months and at the end of the six months
Core temperature
With a gastrointestinal telemetric capsule (e-Celsius)
Measured: Baseline, after three months and at the end of the six months
Skin temperature
iButtons
Measured: Baseline, after three months and at the end of the six months
Nutritional status, how balance is their nutrition
This will be estimated with questionnaires
Measured: Baseline, after three months and at the end of the six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start1 Jun 2023
- Primary completion1 Jul 2023
- Study completion28 Feb 2024
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 Multiple SclerosisStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Thessaly
- Sponsor type
- University, hospital or other
- Collaborators
- Greek Multiple Sclerosis Society, European Committee for Treatment and Research in Multiple Sclerosis
- Responsible party
- Principal investigator, Antonia Kaltsatou, PhD, University of Thessaly
- Investigators
- Anastasios Orologas, MD, PhD, Study chair, Greek Multiple Sclerosis Society
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06248281
- Sponsor's protocol ID
- 396/23
- Acronym
- BeCool
- Status last verified
- May 2024
- First submitted
- 18 Dec 2023
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Once the protocol is completed and published, all the data will be available upon request to other researchers.
Publications
Kaltsatou A, Flouris AD. Impact of pre-cooling therapy on the physical performance and functional capacity of multiple sclerosis patients: A systematic review. Mult Scler Relat Disord. 2019 Jan;27:419-423. doi: 10.1016/j.msard.2018.11.013. Epub 2018 Nov 13.
PubMed 30544086
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Be Cool: An Innovative and Holistic Psychoeducational Program to Improve and Promote Care, Education and Quality of Life for Multiple Sclerosis Individuals
- ClinicalTrials.gov ID
- NCT06248281
- Acronym / sponsor ID
- BeCool / 396/23
- Conditions
- Multiple Sclerosis
- Keywords
- symptom management, hybrid program, rehabilitation, quality of life, psychoeducational program
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of ThessalyUniversity, hospital or other
- Collaborators
- Greek Multiple Sclerosis Society, European Committee for Treatment and Research in Multiple Sclerosis
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 28 Feb 2024 (actual)
- First posted
- 8 Feb 2024 (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.
This observational study aims to investigate the impact of an online psychoeducational program, combined with cooling therapy, nutrition, psychological intervention, and exercise, on the resilience, treatment adherence, symptom management, and quality of life of individuals with Multiple Sclerosis. The study will last for six months, during which two groups of 15 participants with similar characteristics and a diagnosis of Multiple Sclerosis will take part in the protocol. Group A will follow the research protocol, while Group B, the Control group, will not participate in any rehabilitation intervention.
Detailed description
Fifteen individuals with multiple sclerosis will participate in an innovative, hybrid rehabilitation program, encompassing several key components to enhance their well-being. The program includes:
- Exercise Intervention: Participants will engage in specially designed exercise programs. Every two weeks, they will meet virtually with an exercise physiologist via Microsoft Teams for tailored education about their specific needs. Additionally, a customized exercise video will be uploaded weekly to the Teams platform, ensuring ongoing physical engagement.
- Nutritional Evaluation and Education: Nutrition is a core focus. A nutritionist will meet with the participants bi-weekly to discuss their dietary needs and educate them on maintaining a balanced diet to support their condition. Further enhancing this aspect, a nutritious recipe will be uploaded to the platform each week, offering practical dietary guidance.
- Psychological Support: Psychological well-being is addressed through weekly group meetings conducted by a psychologist. These sessions will utilize Acceptance and Commitment Therapy (ACT) strategies to help participants manage their symptoms, accept their condition, and improve their overall quality of life.
- Head and Neck Cooling Strategy: Recognizing the importance of temperature regulation in MS, participants will be advised to apply a cooling strategy to the head and neck area for at least two hours daily, providing symptomatic relief.
To monitor progress and adjust the program as needed, participants' functional ability, nutritional status, psychological condition, and overall quality of life will be evaluated at three key points: baseline (before starting the program), at the three-month mark, and upon completion of the program at six months.
This program is structured to provide a holistic, supportive, and adaptable approach to managing multiple sclerosis, focusing on physical health, nutritional balance, psychological support, and practical strategies for daily living.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | – | Other: combination of different rehabilitation strategiesThe experimental group will attend a structured psychoeducational program developed to build and promote psychological flexibility. In combination with this, participants of this group will have to follow a head and neck cooling protocol. Also, participants of this group will be required to increase their habitual exercise levels and follow a video exercise program specifically designed for their needs and improve their nutrition based on the instructions of a nutritionist and videos specially designed for them. |
| Control group | – | Other: combination of different rehabilitation strategiesAs per the study plan, the Control group has been designated as the control group. They will continue with their normal lifestyle without any participation in rehabilitation activities or programs. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited from the GMSS (https://gmss.gr/) based on specific inclusion and exclusion criteria.
Key inclusion criteria (7 listed)
- Participants must have been diagnosed with MS using the McDonald criteria, ensuring a standardized and validated diagnostic approach.
- Participants should have been relapse-free during the six months leading up to the study to avoid potential confounding factors.
- Participants must have no musculoskeletal impediment that could affect their ability to engage in the exercise component of the program.
- Participants must have a score on the Expanded Disability Status Scale (EDSS) ranging from 0 to 5.5, indicating ambulatory ability without the need for a cane for at least 100 meters.
- Participants should have a history of sensitivity to heat, as reported by their treating physician, justifying the need for cooling therapy as part of the hybrid program.
Key exclusion criteria (3 listed)
- Previously diagnosed conditions known to impact physiological responses to heat exposure, including diabetes mellitus, hypertension, heart disease, or kidney disease.
- Use of medications to manage MS-related symptoms, such as antidepressants, psychostimulants, anticonvulsants, antispasmodics, and anticholinergic drugs.
- -
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 |
|---|---|---|
| combination of different rehabilitation strategiesAlso: cooling therapy, diet, phycology-behavioral-mindfulness intervention, exercise traiiningThe psychoeducational program will be conducted through weekly online video-conferencing group sessions that will last for two hours. In addition to these sessions, participants will receive psychoeducational material such as readings, videos, podcasts, worksheets, and homework exercises every week. This material will allow participants to practice at their own pace during the session intervals. The exercise training program for individuals with MS will be tailored to meet the unique and individual needs of each participant. To achieve this, a head and neck cooling protocol will be implemented using commercially available cooling equipment, specifically the Headcool Power and Neckcool Tie from Inuteq. Participants will need to wear the cooling cup and neck wrap for two hours daily. The equipment will be activated using 10°C tap water. Finally, a nutritionist will provide personalized nutritional guidance including weekly diet observation and recipe videos. | Other | Control group, Experimental group |
Primary outcome
anxiety and depression
Time frame: Baseline, after three months and at the end of the six months
This will be estimated with the "The Hospital Anxiety and Depression Scale - HADS". The Hospital Anxiety and Depression Scale (HADS) is a widely used questionnaire specifically designed to identify and measure the levels of anxiety and depression in individuals. It is particularly useful in medical settings, as it helps distinguish between psychological distress and physical illness.
Overall quality of life, namely satisfaction with their life
Time frame: Baseline, after three months and at the end of the six months
This will be estimated with the questionnaire of Multiple Sclerosis Quality of Life-54 (MSQOL-54)
Perception of stress
Time frame: Baseline, after three months and at the end of the six months
Perceived Stress Scale (PSS) will be used. This is a widely used psychological instrument for measuring the perception of stress. It assesses the degree to which situations in one's life are appraised as stressful. Items on the PSS ask about feelings and thoughts during the last month, and scores on the PSS can range from 0 to 40, with higher scores indicating higher perceived stress.
Cognitive fusion which refers to the degree to which an individual's thoughts and feelings are intertwined with their sense of self, often leading to an inability to separate from, or 'defuse' from, these internal experiences.
Time frame: Baseline, after three months and at the end of the six months
The Cognitive Fusion Questionnaire (CFQ-7) questionnaire that measures cognitive fusion, which a key concept in Acceptance and Commitment Therapy (ACT) will be used. The CFQ-7, with its 7 items, assesses the extent to which a person experiences this phenomenon.
The value of living
Time frame: Baseline, after three months and at the end of the six months
The Valued Living Questionnaire (VLQ) will be used. The VLQ is designed to assess valued living, which is another core concept in ACT. It helps individuals to identify what is truly important and meaningful to them in various domains of life (such as family, career, health) and to what extent they have been living in accordance with these values.
Psychological flexibility which is the ability to be in the present moment with full awareness and openness to experiences, and to take action guided by one's values.
Time frame: Baseline, after three months and at the end of the six months
The MPFI-Psychological Flexibility Subscale will be used. This subscale is part of a larger questionnaire and specifically measures psychological flexibility, an essential aspect of mental health and well-being.
The resilience which is defined as the ability to cope with and bounce back from adversity.
Time frame: Baseline, after three months and at the end of the six months
The Connor-Davidson Resilience Scale (CDRISC-25) will be used. This 25-item scale measures resilience, defined as the ability to cope with and bounce back from adversity. Higher scores indicate greater resilience.
Aerobic capacity and ability to walk
Time frame: Baseline, after three months and at the end of the six months
The Two Minute Walk Test (2MWT) is a simple, easy-to-administer functional exercise test used primarily in clinical settings. It measures the distance an individual is able to walk on a flat, hard surface in a period of two minutes.
Lower body strength and functional mobility
Time frame: Baseline, after three months and at the end of the six months
The Five Times Sit to Stand Test (5xSST) will be used which is a simple yet effective physical performance test used primarily to assess lower body strength and functional mobility. The test involves timing how long it takes an individual to stand up and sit down five times as quickly as possible from a standard height chair without using their arms for support. A longer time to complete the test generally indicates lower functional performance.
Static and dynamic balance ability
Time frame: Baseline, after three months and at the end of the six months
The Berg Balance Scale (BBS) will be used which is a widely used clinical test of a person's static and dynamic balance abilities. It is particularly common in elderly populations and among those recovering from injury or dealing with conditions that affect balance.
Mobility and walking speed
Time frame: Baseline, after three months and at the end of the six months
The Timed 25-Foot Walk (T25-FW) will be used which is a functional test commonly used to assess mobility and walking speed in individuals, particularly those with neurological conditions such as multiple sclerosis (MS).The test involves timing how quickly a person can walk 25 feet at their usual pace, usually conducted along a flat, straight course.
4 secondary outcomes
Finger dexterity and arm-hand coordination
Time frame: Baseline, after three months and at the end of the six months
Core temperature
Time frame: Baseline, after three months and at the end of the six months
Skin temperature
Time frame: Baseline, after three months and at the end of the six months
Nutritional status, how balance is their nutrition
Time frame: Baseline, after three months and at the end of the six months
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 8 May 2024.
- Background: PubMed 30544086Kaltsatou A, Flouris AD. Impact of pre-cooling therapy on the physical performance and functional capacity of multiple sclerosis patients: A systematic review. Mult Scler Relat Disord. 2019 Jan;27:419-423. doi: 10.1016/j.msard.2018.11.013. Epub 2018 Nov 13.
- Individual participant dataSharing planned: No. Once the protocol is completed and published, all the data will be available upon request to other researchers.
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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.
Anastasios Orologas, MD, PhD study chair
Greek Multiple Sclerosis Society
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 Multiple Sclerosis, run by University of Thessaly at 1 site in Greece.
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 7 inclusion and 3 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 8 May 2024. 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 Greece. 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?
anxiety and depression (time frame: Baseline, after three months and at the end of the six months). The study lists 11 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 NCT06248281, 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 8 May 2024; AzTrials last refreshed its copy on 28 Oct 2026.