Chronic ConditionDiSaBNCT06582316
Digital Solution for Salutogenic Brain Health (DiSaB): A Pilot Protocol for Clinical Implementation
A study testing Brain Health Training Programme in people with Chronic Condition, run by National University of Singapore at 1 site in Singapore.
Trial summary
The goal of this clinical trial is to develop and learn if a digitally delivered brain health intervention (DiSaB) can help improve cognitive, physical and psychosocial health in middle-aged adults with chronic conditions at-risk for cognitive decline. Read more about this study
- Who is it for?
- Ages 40 to 64 years
- Conditions the study is for
- Chronic Condition
- What is being tested?
- Brain Health Training Programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteSingapore
- Study dates
- 2 Apr 2025to Jun 2026
- Phase
- Interventional
- 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 40 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged 40 - 55 years old
- Have hypertension, hyperlipidaemia and/or type-2 diabetes
- Ability to provide written informed consent
- Posses sufficient English language skills in reading, writing and speaking
- Multimorbidity conditions are also acceptable with the exception of life-threatening co-morbidities with life expectancy of less than one year
- Total Risk Score (TRS) for cognitive impairment of at least 3
Who cannot join
- Physical, visual and/or hearing impairment
- Language impairment (i.e. severe dysarthria or aphasia)
- Not within age range listed
- Major or active psychiatric conditions
- Diagnosis of dementia
- Do not own a mobile device capable of downloading applications (i.e. Zoom), and/or do not have access to internet connection
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
National University Polyclinics
Singapore
Wei Fong Liau, (65) 67163498, wei_fong_liau@nuhs.edu.sg
About this study
Official title: Digital Solution for Salutogenic Brain Health (DiSaB): A Pilot Sequential Multiple Assignment Randomised Trial (SMART) Protocol for Clinical Implementation
The goal of this clinical trial is to develop and learn if a digitally delivered brain health intervention (DiSaB) can help improve cognitive, physical and psychosocial health in middle-aged adults with chronic conditions at-risk for cognitive decline. The clinical trial also aims to find out the push and pull factors of implementing the intervention in primary care settings. The main questions it aims to answer are:
- Does the DiSaB intervention improve participants' cognitive functions, health measures, and psychosocial health?
- Is an individualised or group-based health education session better at improving cognitive, physical and psychosocial health in participants who did not respond to the DiSaB intervention?
- How useful and practical is the DiSaB intervention, according to
- participants and
- nurses carrying out the intervention?
Read more
The investigators will compare a DiSaB intervention to a control condition (where participants do not undergo any intervention) to see if the DiSaB intervention works in improving participants' health.
The investigators will also compare individualised versus group health education sessions to see which session is better at improving the health of participants who did not respond to the DiSaB intervention.
Participants will
- Complete cognitive assessments, questionnaires, and health tests before intervention, immediately after the intervention, and 6 months after the intervention
- Either undergo no intervention, or undergo the DiSaB intervention over 2 months
- Be randomly selected to attend focus group interviews
Local champions will complete questionnaires and attend focus group interviews after administering and/or co-facilitating the intervention.
Read the detailed description
The effectiveness of the DiSaB intervention implementation at primary care setting amongst participants with long term conditions will be evaluated using the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) model.
Secondly, the barriers and facilitators to DiSaB implementation amongst local champions [e.g., advanced practice nurses (APNs)] will be determined. Specifically, using the Capability, Opportunity, Motivation and Behavior (COM-B) model, the investigators will evaluate the barriers and facilitators towards DiSaB intervention implementation among healthcare professionals.
Third, sequential multiple assignment randomised trial (SMART) study design will also be employed in this study for the development of dynamic treatment regimens (DTRs) tailored for individual needs. The investigators first aim to evaluate the feasibility and compare the efficacy of additional individual intervention (i.e. a health education individual feedback session within 1 - 2 months) vs a smaller group intervention (i.e. health education group sessions over 3 months, once per month) post-standard TYB intervention amongst non-responders, in improving cognitive functions and management of their long-term conditions. Finally, the investigators will compare two embedded DTRs in the SMART, namely, (1) standard TYB followed by individualised health education session for non-responders and usual care for responders, and (2) standard TYB followed by group health education session for non-responders and usual care for responders.
Lastly, an economic evaluation will be carried out to evaluate cost-effectiveness and further impacts of the DiSaB implementation.
- Conditions
- Chronic Condition
- Being tested
- Brain Health Training Programme
- Keywords
- Cognition, Implementation Science, Digital Intervention, Hypertension, Hyperlipidaemia, Type-2 Diabetes
- Medical subject headings
- Chronic Disease, Hypertension, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain Health Training ProgrammeOther
"Train Your Brain (TYB)" - group-based cognitive intervention programme for mild cognitive impairments. This programme equips participants with knowledge on cognition and brain health, provide cognitive coping strategies and boost their confidence and maintain independence in daily activities.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Participants will undergo 8 sessions of digital "Train Your Brain" programme lead by a trained clinical neuropsychologist over 2 months. Receives: Other: Brain Health Training Programme |
| Control Arm | No intervention | Participants will not undergo any sessions of digital "Train Your Brain" programme for 2 months when intervention arm's brain health training programme is ongoing. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in heart rate
Heart rate will be measured on-site
Measured: Baseline (all participants; month 0), first follow up (all participants; month 3), second follow up (only for control group; at month 6), and final follow up (all participants; months 9/12)
Change in lipid levels
Information will be obtained from patients; HealthHub/Health Buddy/OneNUHS or other health apps
Measured: Baseline (all participants; month 0), first follow up (all participants; month 3), second follow up (only for control group; at month 6), and final follow up (all participants; months 9/12)
Change in HbA1c levels
Information will be obtained from patients; HealthHub/Health Buddy/OneNUHS or other health apps
Measured: Baseline (all participants; month 0), first follow up (all participants; month 3), second follow up (only for control group; at month 6), and final follow up (all participants; month 9/12)
Change in blood pressure
Blood pressure will be measured on-site
Measured: Baseline (all participants; month 0), first follow up (all participants; month 3), second follow up (only for control group; at month 6), and final follow up (all participants; month 9/12)
Change in SDMT scores
Symbol Digit Modality Test (SDMT). Total maximum score is 110. Higher scores indicate better cognitive performance.
Measured: Baseline (all participants; month 0), first follow up (all participants; month 3), second follow up (only for control group; at month 6), and final follow up (all participants; month 9/12)
Change in psychosocial health measured by DaSS-21
Depression, Anxiety and Stress Scale -21 item (DASS-21) Physical or online. There are 21 questions that are scored from 0 to 3, and the highest possible score is 63. Higher scores indicate poorer psychological health.
Measured: Baseline (all participants; month 0), first follow up (all participants; month 3), second follow up (only for control group; at month 6), and final follow up (all participants; month 9/12)
Change in MoCA scores
Montreal Cognitive Assessment (MoCA). Total possible score is 30 (scoring is on the MoCA form itself), and a score of at least 26 indicates normal cognition. Higher scores indicate better cognition.
Measured: Baseline (all participants; month 0), first follow up (all participants; month 3), second follow up (only for control group; at month 6), and final follow up (all participants; month 9/12)
Change in quality of life measured by EQ-5D-5L
EuroQol 5 Dimension 5 Level (EQ-5D-5L) Physical or online. Each question is scored from 1 to 5, with 1 indicating no problems in that dimension and 5 indicating total inability to perform in that dimension.
Measured: Baseline (all participants; month 0), first follow up (all participants; month 3), second follow up (only for control group; at month 6), and final follow up (all participants; month 9/12)
Change in psychosocial health measured by AD8
Alzheimer's Disease-8 Component (AD8) Physical or online. There are a total of 8 questions asking about thinking ability, and each answer is coded 1 (yes, change present) or 0 (no change). 0 or 1 indicates normal cognition, and a score of at least 2 suggests that cognition issues might be present.
Measured: Baseline (all participants; month 0), first follow up (all participants; month 3), second follow up (only for control group; at month 6), and final follow up (all participants; month 9/12)
Change in psychosocial health measured by Self-care of chronic illness inventory
Physical or online. 29 questions in total, answers are scored from 1 to 5. Higher scores indicate better self-care. When referencing standard scores, a standard score of 70 is the cut-off point for self-care adequacy.
Measured: Baseline (all participants; month 0), first follow up (all participants; month 3), second follow up (only for control group; at month 6), and final follow up (all participants; month 9/12)
Patient satisfaction feedback questionnaire (patients)
Completed online
Measured: Weekly (right after each TYB intervention) for 2 months. Also after health education sessions: either once [individual session] OR monthly for 3 months [group session]; during months 4-6) - intervention arm non-responders only
Feedback from patients using focus group interview
Questions are developed from RE-AIM model. Participants will be randomly chosen (n=30) to take part in the focus group interview.
Measured: Final follow up (month 9/12)
Effectiveness of TYB intervention questionnaire (nurses)
Using RE-AIM model; completed online. Questionnaire will be given at multiple time points throughout the study, as listed below.
Measured: Weekly for 2 months (after each TYB intervention - months 1-3 for intervention arm and months 4-6 for control arm), final follow up (month 12)
Effectiveness of DiSaB intervention questionnaire (patients)
Using RE-AIM model; completed online. Questionnaire is given at multiple points throughout the study, as listed below.
Measured: Once at the end of TYB intervention (month 3 for intervention arm, month 6 for control arm), once during final follow-up (month 9/12 for all participants)
Feedback from nurses using focus group interview
Questions are developed from RE-AIM model
Measured: Month 6 (immediately after completion of 2-month-long TYB intervention control arm)
Secondary outcomes (1)
Economic evaluation on the feasibility of DiSaB implementation using cost-effectiveness questionnaire
For evaluation of economics and further impact
Measured: Baseline (all participants; month 0), first follow up (all participants; month 3), second follow up (only for control group; at month 6), and final follow up (all participants; months 9/12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start2 Apr 2025
- Primary completionMar 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic ConditionStudies of the same condition, open and under way.
- More trials run by National University of SingaporeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Catherine Yanhong Dong, PhD, National University of Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06582316
- Sponsor's protocol ID
- 2023/00620
- Other IDs
- 2023
- Acronym
- DiSaB
- Status last verified
- Aug 2024
- First submitted
- 16 Aug 2024
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chang CSY, Phua V, Tham XC, Jia Y, Chen NYC, Zhou W, Liau WF, Xu J, Chakraborty B, Graves N, Sevdalis N, Dong Y. Digital solution for salutogenic brain health: a pilot sequential multiple assignment randomised trial (SMART) protocol for clinical implementation. BMJ Open. 2025 Mar 25;15(3):e096568. doi: 10.1136/bmjopen-2024-096568.
PubMed 40132849
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Solution for Salutogenic Brain Health (DiSaB): A Pilot Sequential Multiple Assignment Randomised Trial (SMART) Protocol for Clinical Implementation
- ClinicalTrials.gov ID
- NCT06582316
- Acronym / sponsor ID
- DiSaB / 2023/00620
- Conditions
- Chronic Condition
- Keywords
- Cognition, Implementation Science, Digital Intervention, Hypertension, Hyperlipidaemia, Type-2 Diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- National University of SingaporeUniversity, hospital or other
- Study start
- 2 Apr 2025 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 3 Sep 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.
The goal of this clinical trial is to develop and learn if a digitally delivered brain health intervention (DiSaB) can help improve cognitive, physical and psychosocial health in middle-aged adults with chronic conditions at-risk for cognitive decline. The clinical trial also aims to find out the push and pull factors of implementing the intervention in primary care settings. The main questions it aims to answer are:
- Does the DiSaB intervention improve participants' cognitive functions, health measures, and psychosocial health?
- Is an individualised or group-based health education session better at improving cognitive, physical and psychosocial health in participants who did not respond to the DiSaB intervention?
- How useful and practical is the DiSaB intervention, according to
- participants and
- nurses carrying out the intervention?
The investigators will compare a DiSaB intervention to a control condition (where participants do not undergo any intervention) to see if the DiSaB intervention works in improving participants' health.
The investigators will also compare individualised versus group health education sessions to see which session is better at improving the health of participants who did not respond to the DiSaB intervention.
Participants will
- Complete cognitive assessments, questionnaires, and health tests before intervention, immediately after the intervention, and 6 months after the intervention
- Either undergo no intervention, or undergo the DiSaB intervention over 2 months
- Be randomly selected to attend focus group interviews
Local champions will complete questionnaires and attend focus group interviews after administering and/or co-facilitating the intervention.
Detailed description
The effectiveness of the DiSaB intervention implementation at primary care setting amongst participants with long term conditions will be evaluated using the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) model.
Secondly, the barriers and facilitators to DiSaB implementation amongst local champions [e.g., advanced practice nurses (APNs)] will be determined. Specifically, using the Capability, Opportunity, Motivation and Behavior (COM-B) model, the investigators will evaluate the barriers and facilitators towards DiSaB intervention implementation among healthcare professionals.
Third, sequential multiple assignment randomised trial (SMART) study design will also be employed in this study for the development of dynamic treatment regimens (DTRs) tailored for individual needs. The investigators first aim to evaluate the feasibility and compare the efficacy of additional individual intervention (i.e. a health education individual feedback session within 1 - 2 months) vs a smaller group intervention (i.e. health education group sessions over 3 months, once per month) post-standard TYB intervention amongst non-responders, in improving cognitive functions and management of their long-term conditions. Finally, the investigators will compare two embedded DTRs in the SMART, namely, (1) standard TYB followed by individualised health education session for non-responders and usual care for responders, and (2) standard TYB followed by group health education session for non-responders and usual care for responders.
Lastly, an economic evaluation will be carried out to evaluate cost-effectiveness and further impacts of the DiSaB implementation.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Other: Brain Health Training ProgrammeParticipants will undergo 8 sessions of digital "Train Your Brain" programme lead by a trained clinical neuropsychologist over 2 months. |
| Control Arm | No intervention | –Participants will not undergo any sessions of digital "Train Your Brain" programme for 2 months when intervention arm's brain health training programme is ongoing. |
Who may qualify
- Ages
- 40 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Aged 40 - 55 years old
- Have hypertension, hyperlipidaemia and/or type-2 diabetes
- Ability to provide written informed consent
- Posses sufficient English language skills in reading, writing and speaking
- Multimorbidity conditions are also acceptable with the exception of life-threatening co-morbidities with life expectancy of less than one year
Key exclusion criteria (6 listed)
- Physical, visual and/or hearing impairment
- Language impairment (i.e. severe dysarthria or aphasia)
- Not within age range listed
- Major or active psychiatric conditions
- Diagnosis of dementia
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 |
|---|---|---|
| Brain Health Training Programme"Train Your Brain (TYB)" - group-based cognitive intervention programme for mild cognitive impairments. This programme equips participants with knowledge on cognition and brain health, provide cognitive coping strategies and boost their confidence and maintain independence in daily activities. | Other | Intervention Arm |
Primary outcome
Change in heart rate
Time frame: Baseline (all participants; month 0), first follow up (all participants; month 3), second follow up (only for control group; at month 6), and final follow up (all participants; months 9/12)
Heart rate will be measured on-site
Change in lipid levels
Time frame: Baseline (all participants; month 0), first follow up (all participants; month 3), second follow up (only for control group; at month 6), and final follow up (all participants; months 9/12)
Information will be obtained from patients; HealthHub/Health Buddy/OneNUHS or other health apps
Change in HbA1c levels
Time frame: Baseline (all participants; month 0), first follow up (all participants; month 3), second follow up (only for control group; at month 6), and final follow up (all participants; month 9/12)
Information will be obtained from patients; HealthHub/Health Buddy/OneNUHS or other health apps
Change in blood pressure
Time frame: Baseline (all participants; month 0), first follow up (all participants; month 3), second follow up (only for control group; at month 6), and final follow up (all participants; month 9/12)
Blood pressure will be measured on-site
Change in SDMT scores
Time frame: Baseline (all participants; month 0), first follow up (all participants; month 3), second follow up (only for control group; at month 6), and final follow up (all participants; month 9/12)
Symbol Digit Modality Test (SDMT). Total maximum score is 110. Higher scores indicate better cognitive performance.
Change in psychosocial health measured by DaSS-21
Time frame: Baseline (all participants; month 0), first follow up (all participants; month 3), second follow up (only for control group; at month 6), and final follow up (all participants; month 9/12)
Depression, Anxiety and Stress Scale -21 item (DASS-21) Physical or online. There are 21 questions that are scored from 0 to 3, and the highest possible score is 63. Higher scores indicate poorer psychological health.
Change in MoCA scores
Time frame: Baseline (all participants; month 0), first follow up (all participants; month 3), second follow up (only for control group; at month 6), and final follow up (all participants; month 9/12)
Montreal Cognitive Assessment (MoCA). Total possible score is 30 (scoring is on the MoCA form itself), and a score of at least 26 indicates normal cognition. Higher scores indicate better cognition.
Change in quality of life measured by EQ-5D-5L
Time frame: Baseline (all participants; month 0), first follow up (all participants; month 3), second follow up (only for control group; at month 6), and final follow up (all participants; month 9/12)
EuroQol 5 Dimension 5 Level (EQ-5D-5L) Physical or online. Each question is scored from 1 to 5, with 1 indicating no problems in that dimension and 5 indicating total inability to perform in that dimension.
Change in psychosocial health measured by AD8
Time frame: Baseline (all participants; month 0), first follow up (all participants; month 3), second follow up (only for control group; at month 6), and final follow up (all participants; month 9/12)
Alzheimer's Disease-8 Component (AD8) Physical or online. There are a total of 8 questions asking about thinking ability, and each answer is coded 1 (yes, change present) or 0 (no change). 0 or 1 indicates normal cognition, and a score of at least 2 suggests that cognition issues might be present.
Change in psychosocial health measured by Self-care of chronic illness inventory
Time frame: Baseline (all participants; month 0), first follow up (all participants; month 3), second follow up (only for control group; at month 6), and final follow up (all participants; month 9/12)
Physical or online. 29 questions in total, answers are scored from 1 to 5. Higher scores indicate better self-care. When referencing standard scores, a standard score of 70 is the cut-off point for self-care adequacy.
Patient satisfaction feedback questionnaire (patients)
Time frame: Weekly (right after each TYB intervention) for 2 months. Also after health education sessions: either once [individual session] OR monthly for 3 months [group session]; during months 4-6) - intervention arm non-responders only
Completed online
Feedback from patients using focus group interview
Time frame: Final follow up (month 9/12)
Questions are developed from RE-AIM model. Participants will be randomly chosen (n=30) to take part in the focus group interview.
Effectiveness of TYB intervention questionnaire (nurses)
Time frame: Weekly for 2 months (after each TYB intervention - months 1-3 for intervention arm and months 4-6 for control arm), final follow up (month 12)
Using RE-AIM model; completed online. Questionnaire will be given at multiple time points throughout the study, as listed below.
Effectiveness of DiSaB intervention questionnaire (patients)
Time frame: Once at the end of TYB intervention (month 3 for intervention arm, month 6 for control arm), once during final follow-up (month 9/12 for all participants)
Using RE-AIM model; completed online. Questionnaire is given at multiple points throughout the study, as listed below.
Feedback from nurses using focus group interview
Time frame: Month 6 (immediately after completion of 2-month-long TYB intervention control arm)
Questions are developed from RE-AIM model
1 secondary outcome
Economic evaluation on the feasibility of DiSaB implementation using cost-effectiveness questionnaire
Time frame: Baseline (all participants; month 0), first follow up (all participants; month 3), second follow up (only for control group; at month 6), and final follow up (all participants; months 9/12)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
- Derived from this study: PubMed 40132849Chang CSY, Phua V, Tham XC, Jia Y, Chen NYC, Zhou W, Liau WF, Xu J, Chakraborty B, Graves N, Sevdalis N, Dong Y. Digital solution for salutogenic brain health: a pilot sequential multiple assignment randomised trial (SMART) protocol for clinical implementation. BMJ Open. 2025 Mar 25;15(3):e096568. doi: 10.1136/bmjopen-2024-096568.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brain Health Training Programme in people with Chronic Condition, run by National University of Singapore at 1 site in Singapore.
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 6 inclusion and 6 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 22 May 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 Singapore. 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?
Contact YanHong Dong, PhD (65-65168686, nurdy@nus.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in heart rate (time frame: Baseline (all participants; month 0), first follow up (all participants; month 3), second follow up (only for control group; at month 6), and final follow up (all participants; months 9/12)). The study lists 15 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 NCT06582316, 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 22 May 2025.