Diabetes Mellitus, Type 1YESNCT04670198
A Psychosocial Education Programme for Young People With Type 1 Diabetes - the Youth Empowerment Skills (YES)
A study testing Youth Empowerment Skills in people with Diabetes Mellitus, Type 1, run by King's College London at 5 sites in United Kingdom.
Trial summary
Adolescence is a period of intense physiological, psychological and social change. It can be a challenging period for young people with Type 1 diabetes and is associated with worsening blood sugar control and care disengagement. Read more about this study
- Who is it for?
- Ages 14 to 19 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Youth Empowerment Skills
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 5 sitesUnited Kingdom
- Study dates
- 1 Jun 2021to 31 Mar 2023
- 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 14 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosis of Type 1 diabetes
- Sub-optimal glycaemic control (HbA1c 8.5%)
- No current or planned attendance at other structured education programmes
Who cannot join
- Severe, physical/mental illness
- Pregnancy
- Unstable retinopathy
- Significant learning difficulties
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United Kingdom5 sites
Guy's and St Thomas' NHS Foundation Trust
London, SE1 9RS
University Lewisham Hospital
London, SE13 6LH
Queen Elizabeth Hospital
London, SE18 4QH
King's College Hospital
London, SE5 9RS
St George's University Hospital HS Foundation Trust
London, SW17 0QT
About this study
Official title: A Randomised Waiting-list Feasibility Study and Process Evaluation of a Psychosocial Education Programme for Young People With Type 1 Diabetes - the Youth Empowerment Skills (YES)
Adolescence is a period of intense physiological, psychological and social change. It can be a challenging period for young people with Type 1 diabetes and is associated with worsening blood sugar control and care disengagement. The investigators have co-designed with young people a psychologically modelled educational programme - Youth Empowerment Skills (YES), which aims to facilitate a positive adaption to living with diabetes while improving knowledge and self-management behaviours. Integrated programme components include social and peer-based learning, immersive simulations, and an outreach youth worker.
The aim of this study is to test the feasibility of the YES programme (acceptance, implementability, recruitment and completion), and estimate its efficacy in relation to metabolic and psychosocial outcomes. The investigators will recruit young people with Type 1 diabetes and conduct a feasibility randomised controlled trial (waiting-list design) with integrated process evaluation. Sixty young people will be randomised to either YES intervention or waiting-list control and evaluate outcomes at 6-months; at this point the waiting list participants will be offered the YES intervention with further follow-up at 12 months.
Read the detailed description
The study has been designed as a feasibility study with an integrated process evaluation following MRC guidance (Craig et al., 2008; Moore et al., 2015). The process evaluation data collection has been modelled on the COM_B and the Behaviour Change Wheel framework (BCW) frameworks (Michie et al., 2014; Barker et al., 2016) addressing: policy context; intervention functions; target behaviours; and outcomes. As part of the process evaluation the investigators will also use Consolidated Framework for Implementation Research (CFIR) to study how the programme can be optimally embedded within routine diabetes care, and to optimise the design of a subsequent trial (Murray et al., 2010). The investigators will conduct a feasibility randomised controlled trial (waiting-list design) with integrated process evaluation designed following the Medical Research Council's (MRC) Complex Intervention Evaluation Framework (Craig et al., 2008). Sixty young people will be randomised to either YES intervention or waiting-list control and evaluate outcomes at 6-months; at this point the waiting list participants will be offered the YES intervention with further follow-up at 12 months.
The proportion of patients achieving the progression criteria and the target reduction in glycated haemoglobin (HbA1c) from baseline to follow-up (6 and 12 months) will be estimated in both intervention and waiting list control groups. The investigators will also estimate the standard deviation (SD) of the mean difference between the intervention and waiting list control groups in HbA1c at 6 and 12 months. These statistics will help to inform the sample size calculation of a larger trial.
The process evaluation will consider the setting, implementation, and mechanisms of action of the programme to support interpretation of the outcomes. The process evaluation uses a standardised taxonomy for understanding implementation (Julious, 2005; Proctor et al., 2011), and will assess: the reach, fidelity and receipt of the programme; acceptability, appropriateness and feasibility; unintended consequences; potential sustainability; and implementation costs and strategies. In addition, potential mechanisms of action will be elicited, including changes in behaviours, and how they relate to programme delivery and outcomes.
The investigators will use a mixed-method approach with validated implementation outcome surveys (Powell et al., 2015) and one-to-one interviews with young people, their relatives and healthcare professionals. The data collection tools and analytic models have been designed with reference to the BCW (Michie et al., 2014) and to provide the data for CFIR analysis, considering the barriers and facilitators to the intervention. To ensure relevance and feasibility, the data collection procedures will be refined with the study patient and public involvement groups. Data collection will be conducted at multiple time points to provide opportunities for data triangulation and subsequent theory generation.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Youth Empowerment Skills, Waiting-list control
- Keywords
- Diabetes Mellitus, Type 1, Adolescent, Psychosocial Support Systems
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Youth Empowerment SkillsBehavioural
The Youth Empowerment Skills (YES) programme is a novel psychoeducational intervention with simulation-based experiential learning tailored to the needs of young people. It is based on a social-cognitive learning model, and comprises attendance at 3 all-day YES sessions in non-healthcare settings (groups of 10); and then post-programme networking through social media and follow-up events facilitated by the youth worker. Sessions are led by a peer-educator and a health professional
Waiting-list controlBehavioural
Usual care for 6 months, followed by the YES programme.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention arm will receive the Youth Empowerment Skills (YES) programme. Receives: Behavioral: Youth Empowerment Skills |
| Waiting-list control | Other | The waiting-list control arm will receive usual care for six months before receiving the Youth Empowerment Skills (YES) programme. Receives: Behavioral: Waiting-list control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycated haemoglobin (HbA1c)
HbA1c will be used to measure:
- the number of participants achieving clinically significant reductions of 5.5mmol/mol or more and mean differences between groups over time
- the standard deviation (SD) of the mean difference between the intervention and control group in HbA1c at 6 months; for the control group the SD of the mean difference between HbA1c at 12 months and pre-exposure (phase 2) and for the phase 1 intervention group the SD of the mean HbA1c difference between post (6 and 12 months) and pre-exposure.
Measured: Baseline, 6 months, 12 months
Secondary outcomes (12)
Frequency of blood glucose monitoring
Participants' glucose meters will be downloaded to assess the number of participants with 20% increase in frequency of glucose monitoring between pre- and post-intervention exposure, and any difference between intervention and control groups at 6 months.
Measured: Baseline, 6 months, 12 months
Insulin adherence
Insulin adherence will be measured by self-report scale to assess the number of participants reporting a change in insulin adherence between pre- and post-intervention exposure, and the difference between intervention and control groups at 6 months.
Maximum score is 10 and minimum score is 2. Higher scores indicate better adherence.
Measured: Baseline, 6 months, 12 months
Self-Management of Diabetes in Adolescence Scale (SMOD-A)
The SMOD-A will be used to assess any change in self-management of diabetes between pre- and post-intervention exposure, and the difference between intervention and control groups at 6 months. This consists of five subscales.
Subscale 1: Collaboration with Parents. The range of scores is 0 to 39. Higher scores indicate more collaboration.
Subscale 2: Diabetes Care Activities. The range it 0 to 45. Higher scores indicate more/better performance of these diabetes tasks.
Subscale 3: Diabetes Problem-Solving. Range of scores is 0 to 21. Higher scores indicate better/more problem-solving.
Subscale 4: Diabetes Communication. The range of scores is 0 to 30. Higher scores indicate better/more communication.
Subscale 5: Goals. The range of scores is 0 to 21. Higher scores indicate more goals.
Measured: Baseline, 6 months, 12 months
Confidence in Diabetes Self-Care Scale (CDSS)
The CDSS will be used to measure any change in confidence in diabetes self-care between pre-and post-intervention exposure, and between intervention and control groups at 6 months. Maximum value is 100, minimum value is 20. Higher score means more confidence.
Measured: Baseline, 6 months, 12 months
Diabetes Quality of Life Instrument (DQOL) (adapted for youth)
The DQOL will be used to assess any change in quality of life between pre- and post-intervention exposure, and the difference between intervention and control groups at 6 months.
DQOL has 3 subscales:
Subscale 1: Impact of diabetes. Maximum value is 120. Minimum value is 24. Higher scores indicate more impact of diabetes on quality of life.
Sunscale 2: Worries about diabetes. Maximum score is 55. Minimum score is 11. Higher scores mean more worries.
Subscale 3: Satisfaction with life. Maximum score 85. Minimum score 5. Higher score means more satisfied.
Measured: Baseline, 6 months, 12 months
Brief Illness Perception Questionnaire (IPQ-B)
The IPQ-B will be used to measure any change in diabetes perception between pre- and post-intervention exposure, and the difference between intervention and control groups at 6 months. Each of the eight dimensions measured uses a maximum score of 10 and a minimum score of 0. A higher score indicates more severe perception of illness.
Measured: Baseline, 6 months, 12 months
Emergency care events
The number of ambulance call-outs, Accident \& Emergency attendance and hospitalisations will be taken from hospital records to assess any change in number of events between pre- and post-intervention exposure, and the difference between intervention and control groups at 6 months.
Measured: Baseline, 6 months, 12 months
Hypoglycaemia and severe hypoglycaemic events
Hypoglycaemia is defined as blood glucose 3.5 mmol/L and severe hypoglycaemic events are defined as requiring 3rd party assistance. The number of events will be taken from hospital records to assess any change in hypoglycaemia and severe hypoglycaemic events between pre- and post-intervention exposure, and the difference between intervention and control groups at 6 months.
Measured: Baseline, 6 months, 12 months
Weight
Participants will be weighed at baseline, 6 and 12 months to assess any change in weight between pre- and post-intervention exposure, and the difference between intervention and control groups at 6 months.
Measured: Baseline, 6 months, 12 months
Intervention Appropriateness Measure (IAM)
Intervention Appropriateness Measure will be used to assess the appropriateness of the intervention. It is a four-item questionnaire measuring implementation outcomes. Score values range from 1 to 5. The higher the score the more appropriate the intervention.
Measured: Within 3 months of intervention
Feasibility of Intervention Measure (FIM)
Feasibility of Intervention Measure will be used to assess the feasibility of the intervention. It is a four-item questionnaire measuring implementation outcomes. Score values range from 1 to 5. The higher the score the more feasible the intervention.
Measured: Within 3 months of intervention
Acceptability of Intervention Measure (AIM)
Acceptability of Intervention Measure will be used to assess the acceptability of the intervention. It is a four-item questionnaire measuring implementation outcomes. Score values range from 1 to 5. The higher the score the more acceptable the intervention.
Measured: Within 3 months of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start1 Jun 2021
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
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 Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by King's College LondonThe 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
- Crossover
- Model description
- The study has been designed as a waiting-list randomised controlled trial (RCT). Young people will be randomised to either the phase 1 YES group or the waiting-list control group. The phase 1 YES group will then attend the programme, both groups will be followed-up initially for 6 months, at which point the waiting-list control participants will attend the YES programme in phase 2. Both groups will then be followed-up for a further 6 months.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust, Diabetes UK
- Responsible party
- Sponsor
- Investigators
- Angus Forbes, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04670198
- Sponsor's protocol ID
- D-UK 19/0006055
- Acronym
- YES
- Status last verified
- Sep 2023
- First submitted
- 17 Nov 2020
- Last updated
- 6 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD that underlie results in a publication will be shared
Publications
Kariyawasam D, Soukup T, Parsons J, Sevdalis N, Baldellou Lopez M, Forde R, Ismail K, Jones M, Ford-Adams M, Yemane N, Pender S, Thomas S, Murrells T, Silverstien A, Forbes A. Protocol for a feasibility study and process evaluation of a psychosocially modelled diabetes education programme for young people with type 1 diabetes: the Youth Empowerment Skills (YES) programme. BMJ Open. 2022 Jun 9;12(6):e062971. doi: 10.1136/bmjopen-2022-062971.
PubMed 35680254
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Waiting-list Feasibility Study and Process Evaluation of a Psychosocial Education Programme for Young People With Type 1 Diabetes - the Youth Empowerment Skills (YES)
- ClinicalTrials.gov ID
- NCT04670198
- Acronym / sponsor ID
- YES / D-UK 19/0006055
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Diabetes Mellitus, Type 1, Adolescent, Psychosocial Support Systems
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust, Diabetes UK
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 17 Dec 2020 (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.
Adolescence is a period of intense physiological, psychological and social change. It can be a challenging period for young people with Type 1 diabetes and is associated with worsening blood sugar control and care disengagement. The investigators have co-designed with young people a psychologically modelled educational programme - Youth Empowerment Skills (YES), which aims to facilitate a positive adaption to living with diabetes while improving knowledge and self-management behaviours. Integrated programme components include social and peer-based learning, immersive simulations, and an outreach youth worker.
The aim of this study is to test the feasibility of the YES programme (acceptance, implementability, recruitment and completion), and estimate its efficacy in relation to metabolic and psychosocial outcomes. The investigators will recruit young people with Type 1 diabetes and conduct a feasibility randomised controlled trial (waiting-list design) with integrated process evaluation. Sixty young people will be randomised to either YES intervention or waiting-list control and evaluate outcomes at 6-months; at this point the waiting list participants will be offered the YES intervention with further follow-up at 12 months.
Detailed description
The study has been designed as a feasibility study with an integrated process evaluation following MRC guidance (Craig et al., 2008; Moore et al., 2015). The process evaluation data collection has been modelled on the COM_B and the Behaviour Change Wheel framework (BCW) frameworks (Michie et al., 2014; Barker et al., 2016) addressing: policy context; intervention functions; target behaviours; and outcomes. As part of the process evaluation the investigators will also use Consolidated Framework for Implementation Research (CFIR) to study how the programme can be optimally embedded within routine diabetes care, and to optimise the design of a subsequent trial (Murray et al., 2010). The investigators will conduct a feasibility randomised controlled trial (waiting-list design) with integrated process evaluation designed following the Medical Research Council's (MRC) Complex Intervention Evaluation Framework (Craig et al., 2008). Sixty young people will be randomised to either YES intervention or waiting-list control and evaluate outcomes at 6-months; at this point the waiting list participants will be offered the YES intervention with further follow-up at 12 months.
The proportion of patients achieving the progression criteria and the target reduction in glycated haemoglobin (HbA1c) from baseline to follow-up (6 and 12 months) will be estimated in both intervention and waiting list control groups. The investigators will also estimate the standard deviation (SD) of the mean difference between the intervention and waiting list control groups in HbA1c at 6 and 12 months. These statistics will help to inform the sample size calculation of a larger trial.
The process evaluation will consider the setting, implementation, and mechanisms of action of the programme to support interpretation of the outcomes. The process evaluation uses a standardised taxonomy for understanding implementation (Julious, 2005; Proctor et al., 2011), and will assess: the reach, fidelity and receipt of the programme; acceptability, appropriateness and feasibility; unintended consequences; potential sustainability; and implementation costs and strategies. In addition, potential mechanisms of action will be elicited, including changes in behaviours, and how they relate to programme delivery and outcomes.
The investigators will use a mixed-method approach with validated implementation outcome surveys (Powell et al., 2015) and one-to-one interviews with young people, their relatives and healthcare professionals. The data collection tools and analytic models have been designed with reference to the BCW (Michie et al., 2014) and to provide the data for CFIR analysis, considering the barriers and facilitators to the intervention. To ensure relevance and feasibility, the data collection procedures will be refined with the study patient and public involvement groups. Data collection will be conducted at multiple time points to provide opportunities for data triangulation and subsequent theory generation.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study has been designed as a waiting-list randomised controlled trial (RCT). Young people will be randomised to either the phase 1 YES group or the waiting-list control group. The phase 1 YES group will then attend the programme, both groups will be followed-up initially for 6 months, at which point the waiting-list control participants will attend the YES programme in phase 2. Both groups will then be followed-up for a further 6 months.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Youth Empowerment SkillsThe intervention arm will receive the Youth Empowerment Skills (YES) programme. |
| Waiting-list control | Other | Behavioral: Waiting-list controlThe waiting-list control arm will receive usual care for six months before receiving the Youth Empowerment Skills (YES) programme. |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Diagnosis of Type 1 diabetes
- Sub-optimal glycaemic control (HbA1c 8.5%)
- No current or planned attendance at other structured education programmes
Key exclusion criteria (4 listed)
- Severe, physical/mental illness
- Pregnancy
- Unstable retinopathy
- Significant learning difficulties
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 |
|---|---|---|
| Youth Empowerment SkillsThe Youth Empowerment Skills (YES) programme is a novel psychoeducational intervention with simulation-based experiential learning tailored to the needs of young people. It is based on a social-cognitive learning model, and comprises attendance at 3 all-day YES sessions in non-healthcare settings (groups of 10); and then post-programme networking through social media and follow-up events facilitated by the youth worker. Sessions are led by a peer-educator and a health professional | Behavioural | Intervention |
| Waiting-list controlUsual care for 6 months, followed by the YES programme. | Behavioural | Waiting-list control |
Primary outcome
Glycated haemoglobin (HbA1c)
Time frame: Baseline, 6 months, 12 months
HbA1c will be used to measure: 1. the number of participants achieving clinically significant reductions of 5.5mmol/mol or more and mean differences between groups over time 2. the standard deviation (SD) of the mean difference between the intervention and control group in HbA1c at 6 months; for the control group the SD of the mean difference between HbA1c at 12 months and pre-exposure (phase 2) and for the phase 1 intervention group the SD of the mean HbA1c difference between post (6 and 12 months) and pre-exposure.
12 secondary outcomes
Frequency of blood glucose monitoring
Time frame: Baseline, 6 months, 12 months
Insulin adherence
Time frame: Baseline, 6 months, 12 months
Self-Management of Diabetes in Adolescence Scale (SMOD-A)
Time frame: Baseline, 6 months, 12 months
Confidence in Diabetes Self-Care Scale (CDSS)
Time frame: Baseline, 6 months, 12 months
Diabetes Quality of Life Instrument (DQOL) (adapted for youth)
Time frame: Baseline, 6 months, 12 months
Brief Illness Perception Questionnaire (IPQ-B)
Time frame: Baseline, 6 months, 12 months
Emergency care events
Time frame: Baseline, 6 months, 12 months
Hypoglycaemia and severe hypoglycaemic events
Time frame: Baseline, 6 months, 12 months
Weight
Time frame: Baseline, 6 months, 12 months
Intervention Appropriateness Measure (IAM)
Time frame: Within 3 months of intervention
Feasibility of Intervention Measure (FIM)
Time frame: Within 3 months of intervention
Acceptability of Intervention Measure (AIM)
Time frame: Within 3 months of intervention
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 6 Oct 2023.
- Derived from this study: PubMed 35680254Kariyawasam D, Soukup T, Parsons J, Sevdalis N, Baldellou Lopez M, Forde R, Ismail K, Jones M, Ford-Adams M, Yemane N, Pender S, Thomas S, Murrells T, Silverstien A, Forbes A. Protocol for a feasibility study and process evaluation of a psychosocially modelled diabetes education programme for young people with type 1 diabetes: the Youth Empowerment Skills (YES) programme. BMJ Open. 2022 Jun 9;12(6):e062971. doi: 10.1136/bmjopen-2022-062971.
- Individual participant dataSharing planned: Yes. IPD that underlie results in a publication will be shared
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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.
Angus Forbes principal investigator
King's College London
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Youth Empowerment Skills in people with Diabetes Mellitus, Type 1, run by King's College London at 5 sites in United Kingdom.
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 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United Kingdom. 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?
Glycated haemoglobin (HbA1c) (time frame: Baseline, 6 months, 12 months). 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 NCT04670198, 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 6 Oct 2023.