Musculoskeletal DisorderITASPANCT05866978
An Integrated Approach to Health, Wellbeing, and Productivity at Work
A study testing Integrated Approach to Health, Wellbeing, and Productivity at Work (ITASPA) in people with Musculoskeletal Disorder and Mental Health Issue, run by Holbaek Sygehus at 1 site in Denmark.
Trial summary
The goal of the workplace intervention study 'An Integrated Approach to Health, Wellbeing, and Productivity at Work (ITASPA)' is to examine the effect of the Australian WorkHealth Improvement Network (WIN) program in a Danish context among blue-collar workers. Read more about this study
- Who is it for?
- Ages 18 to 67 yearsHealthy volunteers can take part
- Conditions the study is for
- Musculoskeletal Disorder, Mental Health Issue, Work-related Illness
- What is being tested?
- Integrated Approach to Health, Wellbeing, and Productivity at Work (ITASPA)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Apr 2021to 31 Dec 2024
- 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 18 to 67 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Employed at one of the enrolled worksites ≥ 20 hours/week, providing an informed signed consent prior to participation.
Who cannot join
- Being pregnant; not being able to understand and speak Danish or English
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Department of Occupational and Social Medicine
Holbæk, Region Sjælland, 4300
Mette Korshøj, PhD, 004559489851, melars@regionsjaelland.dk
Ole Steen Mortensen, PhD, 004559489851, osm@regionsjaelland.dk
About this study
The goal of the workplace intervention study 'An Integrated Approach to Health, Wellbeing, and Productivity at Work (ITASPA)' is to examine the effect of the Australian WorkHealth Improvement Network (WIN) program in a Danish context among blue-collar workers. The project is evaluated via its effect on: 1) Musculoskeletal disorders (MSD), 2) Functionality, 3) Psychosocial wellbeing, and 4) Safety culture. Based on identified work health challenges at the included workplace, a group of employees at each worksite will develop and implement their own health promoting activities. Remaining employees will participate in one screening questionnaire prior to the intervention followed by five health checks and interview based questionnaires. All intervention activities and health checks take place at the participants' workplace during paid working hours. In our study design, participants will be compared to themselves and their previous measurements. Furthermore, we will compare the worksites.
Read the detailed description
The aim of the 'Integrated Approach to Health, Wellbeing, and Productivity at Work (ITASPA)' project is to investigate the effect of the Australian WorkHealth Improvement Network (WIN) program and the Total Worker Health (TWH) concepts in a Danish context among blue-collar workers. The project is evaluated via its effect on: 1) Musculoskeletal disorders (MSD), 2) Functionality, 3) Psychosocial wellbeing, and 4) Safety culture. In addition, we evaluate the intervention effect on BMI, heart rate, and blood pressure. Furthermore, the ITASPA project aims to examine the degree of implementation of the initiated initiatives and identify barriers and facilitating factors for implementation. This contributes to the knowledge about what characterizes best practices for the implementation of integrated workplace interventions.
Based on identified work health challenges at the included worksites, a group of employees at each workplace will develop and implement their own project activities. Remaining employees will participate in one screening questionnaire prior to the intervention followed by five health checks and interview based questionnaires. All intervention activities and health checks take place at the participants' workplace during paid working hours.
ITASPA is a workplace intervention, conducted in a stepped wedge design. The stepped wedge design are assumed to increase the willingness to participate as it allows all workers to receive the intervention. The workers function as their own control and thereby, the stepped wedge design allows for an effect-evaluation, mimicking an RCT design.
To increase the transferring of the WIN program to a broad variety of Danish worksites, both public and private worksites are aimed to be enrolled. The worksites will be enrolled on basis of their willingness to perform the ITASPA activities during paid worktime and participation in the scientific evaluation of the ITASPA project.
The ITASPA project will be organized by a steering group consisting of the ITASPA project managers, representatives from the senior management at the enrolled worksites, and the ITASPA facilitators from the Department of Occupational and Social Medicine at Holbæk Hospital, Denmark. Moreover, the steering group includes an advisory board consisting of the developers of the WIN program and TWH concept. The advisory board will provide information about international experiences with integrated workplace interventions to assist the development of workplace health interventions in Denmark.
- Conditions
- Musculoskeletal Disorder, Mental Health Issue, Work-related Illness, Safety Issues, Work Environment Adverse Effects
- Being tested
- Integrated Approach to Health, Wellbeing, and Productivity at Work (ITASPA)
- Keywords
- total worker health, occupational safety and health, intervention development, cleaning assistants, pain and injury, wellbeing, working conditions, work environment, workhealth improvement network
- Medical subject headings
- Musculoskeletal Diseases, Occupational Stress, Pain, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated Approach to Health, Wellbeing, and Productivity at Work (ITASPA)Behavioural
The intervention investigates the effect of the Australian WorkHealth Improvement Network (WIN) program and the Total Worker Health (TWH) concepts in a Danish context among blue-collar workers.
| Study group | Role | What they receive |
|---|---|---|
| An integrated workplace intervention | Other | Intervention: A group of employees at each workplace will develop and implement their own project activities at meetings four times during the intervention. Activities are implemented at workplaces for all employees. Employees will participate in one screening questionnaire prior to the intervention followed by five health checks and interview based questionnaires. Receives: Behavioral: Integrated Approach to Health, Wellbeing, and Productivity at Work (ITASPA) |
| Reference | No intervention | Reference: No intervention activities. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of musculoskeletal disorders from baseline to 6, 9, 12 and 15 months after randomization
The Short Form of the Örebro Musculoskeletal Pain Screening Questionnaire will be used to measure musculoskeletal disorders
Measured: Data on musculoskeletal disorders are collected 3 months after randomization. Additional follow up data are collected 6, 9, 12 and 15 months after randomization.
Change of functionality from baseline to 6, 9, 12 and 15 months after randomization
Functionality will be measured by the ICF-based Work Rehabilitation Questionnaire (WORQ) (https://myworq.org/)
Measured: Data on functionality are collected 3 months after randomization. Additional follow up data are collected 6, 9, 12 and 15 months after randomization.
Change of psychosocial wellbeing from baseline to 6, 9, 12 and 15 months after randomization
Psychosocial wellbeing will be measured via the Health Survey SF-12
Measured: Data on psychosocial wellbeing are collected 3 months after randomization. Additional follow up data are collected 6, 9, 12 and 15 months after randomization.
Change of safety culture from baseline to 6, 9, 12 and 15 months after randomization
Safety culture will be measured by the Nordic Occupational Safety Climate Questionnaire (NOSACQ-50)
Measured: Data on safety culture are collected 3 months after randomization. Additional follow up data are collected 6, 9, 12 and 15 months after randomization.
Change of body weight (kg) from baseline to 6, 9, 12 and 15 months after randomization
Bodyweight will be measured while the participant is wearing light clothes and no shoes. The estimated weight of clothes (1.5 kg) will be subtracted from body weight. Percent body fat will be estimated by bioelectric-impedance-analysis. Both body weight and percent body fat will be measured by a Segmental Body Composition Monitor, Innerscan V, BC545N (TANITA, produced in Japan). If participants have a pacemaker or are pregnant, the analysis of percent body fat will not be made. Body height will be measured on a mobile stadiometer Seca 213 (Seca, produced in China). Body mass index (BMI) will be estimated by the equation of BMI = (body weight (kg)/body height (m)2).
Measured: Data on body weight (kg) are collected 3 months after randomization. Additional follow up data are collected 6, 9, 12 and 15 months after randomization.
Change of percent body fat from baseline to 6, 9, 12 and 15 months after randomization
Percent body fat will be measured while the participant is wearing light clothes and no shoes. The estimated weight of clothes (1.5 kg) will be subtracted from body weight. Percent body fat will be estimated by bioelectric-impedance-analysis. Both body weight and percent body fat will be measured by a Segmental Body Composition Monitor, Innerscan V, BC545N (TANITA, produced in Japan). If participants have a pacemaker or are pregnant, the analysis of percent body fat will not be made. Body height will be measured on a mobile stadiometer Seca 213 (Seca, produced in China). Body mass index (BMI) will be estimated by the equation of BMI = (body weight (kg)/body height (m)2).
Measured: Data on percent body fat are collected 3 months after randomization. Additional follow up data are collected 6, 9, 12 and 15 months after randomization.
Change of resting heart rate (beats per minute) from baseline to 6, 9, 12 and 15 months after randomization.
Resting heart rate will be measured three times on the left arm after 15 minutes of sitting at rest using an Omron Model M3, automatic upper arm BP monitor (Omron healthcare, produced in Vietnam).
Measured: Data on heart rate are collected 3 months after randomization. Additional follow up data are collected 6, 9, 12 and 15 months after randomization.
Change of blood pressure (mmHg) from baseline to 6, 9, 12 and 15 months after randomization.
Blood pressure will be measured three times on the left arm after 15 minutes of sitting at rest using an Omron Model M3, automatic upper arm BP monitor (Omron healthcare, produced in Vietnam).
Measured: Blood pressure are collected 3 months after randomization. Additional follow up data are collected 6, 9, 12 and 15 months after randomization.
Secondary outcomes (1)
Change of sickness absence from 12 months prior to the randomization and 12 months after the last (15 months) follow up.
Information on sickness absence is provided by the administration at workplaces
Measured: Data on sickness absence are collected from 12 months prior to the randomization and 12 months after the last (15 months) follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start1 Apr 2021
- Primary completion1 Jun 2024 (estimated)
- Study completion31 Dec 2024 (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 Musculoskeletal DisorderStudies 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
- Sequential
- Model description
- Using a stepped-wedge design, participants at the enrolled worksites function as their own control. Thus, the effect of the intervention is evaluated as in an RCT design. All employees are asked to complete a short screening questionnaire. Those who wish to participate are invited to the data collection containing: Signing of consent, measurements of height, body weight, fat percentage and blood pressure and answering a questionnaire. No preparation is required of the participants before data collection begins. All intervention activities and health checks take place at the participants' workplace during paid working hours. Calculation, analysis and interpretation of data will take place at the Department of Occupational and Social Medicine, Holbæk Hospital. The intervention activities are developed by a local commitee including participants and managers, acoording a participatory approach and following the Work Health Improvements Network concept.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Holbaek Sygehus
- Sponsor type
- University, hospital or other
- Collaborators
- Region Zealand
- Responsible party
- Sponsor
- Investigators
- Mette Korshøj, PhD, Principal investigator, Holbaek Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05866978
- Sponsor's protocol ID
- R22A547
- Other IDs
- SJ-927, REG-034-2021
- Acronym
- ITASPA
- Status last verified
- May 2023
- First submitted
- 29 Mar 2023
- Last updated
- 19 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Korshoj M, Poulsen VR, Skold MB, Autrup SK, Oldenburg B, Mortensen OS. An integrated approach to health, wellbeing, and productivity at work: a design of a stepped wedge worksite intervention study. BMC Public Health. 2023 Jun 2;23(1):1057. doi: 10.1186/s12889-023-16014-x.
PubMed 37268907
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Integrated Approach to Health, Wellbeing, and Productivity at Work
- ClinicalTrials.gov ID
- NCT05866978
- Acronym / sponsor ID
- ITASPA / R22A547
- Conditions
- Musculoskeletal Disorder, Mental Health Issue, Work-related Illness, Safety Issues, Work Environment Adverse Effects
- Keywords
- total worker health, occupational safety and health, intervention development, cleaning assistants, pain and injury, wellbeing, working conditions, work environment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Holbaek SygehusUniversity, hospital or other
- Collaborators
- Region Zealand
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 19 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of the workplace intervention study 'An Integrated Approach to Health, Wellbeing, and Productivity at Work (ITASPA)' is to examine the effect of the Australian WorkHealth Improvement Network (WIN) program in a Danish context among blue-collar workers. The project is evaluated via its effect on: 1) Musculoskeletal disorders (MSD), 2) Functionality, 3) Psychosocial wellbeing, and 4) Safety culture. Based on identified work health challenges at the included workplace, a group of employees at each worksite will develop and implement their own health promoting activities. Remaining employees will participate in one screening questionnaire prior to the intervention followed by five health checks and interview based questionnaires. All intervention activities and health checks take place at the participants' workplace during paid working hours. In our study design, participants will be compared to themselves and their previous measurements. Furthermore, we will compare the worksites.
Detailed description
The aim of the 'Integrated Approach to Health, Wellbeing, and Productivity at Work (ITASPA)' project is to investigate the effect of the Australian WorkHealth Improvement Network (WIN) program and the Total Worker Health (TWH) concepts in a Danish context among blue-collar workers. The project is evaluated via its effect on: 1) Musculoskeletal disorders (MSD), 2) Functionality, 3) Psychosocial wellbeing, and 4) Safety culture. In addition, we evaluate the intervention effect on BMI, heart rate, and blood pressure. Furthermore, the ITASPA project aims to examine the degree of implementation of the initiated initiatives and identify barriers and facilitating factors for implementation. This contributes to the knowledge about what characterizes best practices for the implementation of integrated workplace interventions.
Based on identified work health challenges at the included worksites, a group of employees at each workplace will develop and implement their own project activities. Remaining employees will participate in one screening questionnaire prior to the intervention followed by five health checks and interview based questionnaires. All intervention activities and health checks take place at the participants' workplace during paid working hours.
ITASPA is a workplace intervention, conducted in a stepped wedge design. The stepped wedge design are assumed to increase the willingness to participate as it allows all workers to receive the intervention. The workers function as their own control and thereby, the stepped wedge design allows for an effect-evaluation, mimicking an RCT design.
To increase the transferring of the WIN program to a broad variety of Danish worksites, both public and private worksites are aimed to be enrolled. The worksites will be enrolled on basis of their willingness to perform the ITASPA activities during paid worktime and participation in the scientific evaluation of the ITASPA project.
The ITASPA project will be organized by a steering group consisting of the ITASPA project managers, representatives from the senior management at the enrolled worksites, and the ITASPA facilitators from the Department of Occupational and Social Medicine at Holbæk Hospital, Denmark. Moreover, the steering group includes an advisory board consisting of the developers of the WIN program and TWH concept. The advisory board will provide information about international experiences with integrated workplace interventions to assist the development of workplace health interventions in Denmark.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Using a stepped-wedge design, participants at the enrolled worksites function as their own control. Thus, the effect of the intervention is evaluated as in an RCT design. All employees are asked to complete a short screening questionnaire. Those who wish to participate are invited to the data collection containing: Signing of consent, measurements of height, body weight, fat percentage and blood pressure and answering a questionnaire. No preparation is required of the participants before data collection begins. All intervention activities and health checks take place at the participants' workplace during paid working hours. Calculation, analysis and interpretation of data will take place at the Department of Occupational and Social Medicine, Holbæk Hospital. The intervention activities are developed by a local commitee including participants and managers, acoording a participatory approach and following the Work Health Improvements Network concept.
| Arm | Type | Receives |
|---|---|---|
| An integrated workplace intervention | Other | Behavioral: Integrated Approach to Health, Wellbeing, and Productivity at Work (ITASPA)Intervention: A group of employees at each workplace will develop and implement their own project activities at meetings four times during the intervention. Activities are implemented at workplaces for all employees. Employees will participate in one screening questionnaire prior to the intervention followed by five health checks and interview based questionnaires. |
| Reference | No intervention | –Reference: No intervention activities. |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Employed at one of the enrolled worksites ≥ 20 hours/week, providing an informed signed consent prior to participation.
Key exclusion criteria (1 listed)
- Being pregnant; not being able to understand and speak Danish or English
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 |
|---|---|---|
| Integrated Approach to Health, Wellbeing, and Productivity at Work (ITASPA)The intervention investigates the effect of the Australian WorkHealth Improvement Network (WIN) program and the Total Worker Health (TWH) concepts in a Danish context among blue-collar workers. | Behavioural | An integrated workplace intervention |
Primary outcome
Change of musculoskeletal disorders from baseline to 6, 9, 12 and 15 months after randomization
Time frame: Data on musculoskeletal disorders are collected 3 months after randomization. Additional follow up data are collected 6, 9, 12 and 15 months after randomization.
The Short Form of the Örebro Musculoskeletal Pain Screening Questionnaire will be used to measure musculoskeletal disorders
Change of functionality from baseline to 6, 9, 12 and 15 months after randomization
Time frame: Data on functionality are collected 3 months after randomization. Additional follow up data are collected 6, 9, 12 and 15 months after randomization.
Functionality will be measured by the ICF-based Work Rehabilitation Questionnaire (WORQ) (https://myworq.org/)
Change of psychosocial wellbeing from baseline to 6, 9, 12 and 15 months after randomization
Time frame: Data on psychosocial wellbeing are collected 3 months after randomization. Additional follow up data are collected 6, 9, 12 and 15 months after randomization.
Psychosocial wellbeing will be measured via the Health Survey SF-12
Change of safety culture from baseline to 6, 9, 12 and 15 months after randomization
Time frame: Data on safety culture are collected 3 months after randomization. Additional follow up data are collected 6, 9, 12 and 15 months after randomization.
Safety culture will be measured by the Nordic Occupational Safety Climate Questionnaire (NOSACQ-50)
Change of body weight (kg) from baseline to 6, 9, 12 and 15 months after randomization
Time frame: Data on body weight (kg) are collected 3 months after randomization. Additional follow up data are collected 6, 9, 12 and 15 months after randomization.
Bodyweight will be measured while the participant is wearing light clothes and no shoes. The estimated weight of clothes (1.5 kg) will be subtracted from body weight. Percent body fat will be estimated by bioelectric-impedance-analysis. Both body weight and percent body fat will be measured by a Segmental Body Composition Monitor, Innerscan V, BC545N (TANITA, produced in Japan). If participants have a pacemaker or are pregnant, the analysis of percent body fat will not be made. Body height will be measured on a mobile stadiometer Seca 213 (Seca, produced in China). Body mass index (BMI) will be estimated by the equation of BMI = (body weight (kg)/body height (m)2).
Change of percent body fat from baseline to 6, 9, 12 and 15 months after randomization
Time frame: Data on percent body fat are collected 3 months after randomization. Additional follow up data are collected 6, 9, 12 and 15 months after randomization.
Percent body fat will be measured while the participant is wearing light clothes and no shoes. The estimated weight of clothes (1.5 kg) will be subtracted from body weight. Percent body fat will be estimated by bioelectric-impedance-analysis. Both body weight and percent body fat will be measured by a Segmental Body Composition Monitor, Innerscan V, BC545N (TANITA, produced in Japan). If participants have a pacemaker or are pregnant, the analysis of percent body fat will not be made. Body height will be measured on a mobile stadiometer Seca 213 (Seca, produced in China). Body mass index (BMI) will be estimated by the equation of BMI = (body weight (kg)/body height (m)2).
Change of resting heart rate (beats per minute) from baseline to 6, 9, 12 and 15 months after randomization.
Time frame: Data on heart rate are collected 3 months after randomization. Additional follow up data are collected 6, 9, 12 and 15 months after randomization.
Resting heart rate will be measured three times on the left arm after 15 minutes of sitting at rest using an Omron Model M3, automatic upper arm BP monitor (Omron healthcare, produced in Vietnam).
Change of blood pressure (mmHg) from baseline to 6, 9, 12 and 15 months after randomization.
Time frame: Blood pressure are collected 3 months after randomization. Additional follow up data are collected 6, 9, 12 and 15 months after randomization.
Blood pressure will be measured three times on the left arm after 15 minutes of sitting at rest using an Omron Model M3, automatic upper arm BP monitor (Omron healthcare, produced in Vietnam).
1 secondary outcome
Change of sickness absence from 12 months prior to the randomization and 12 months after the last (15 months) follow up.
Time frame: Data on sickness absence are collected from 12 months prior to the randomization and 12 months after the last (15 months) follow up.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2023.
- Derived from this study: PubMed 37268907Korshoj M, Poulsen VR, Skold MB, Autrup SK, Oldenburg B, Mortensen OS. An integrated approach to health, wellbeing, and productivity at work: a design of a stepped wedge worksite intervention study. BMC Public Health. 2023 Jun 2;23(1):1057. doi: 10.1186/s12889-023-16014-x.
- 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. This study is not recruiting at the moment.
Mette Korshøj, PhD principal investigator
Holbaek Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated Approach to Health, Wellbeing, and Productivity at Work (ITASPA) in people with Musculoskeletal Disorder and Mental Health Issue, run by Holbaek Sygehus at 1 site in Denmark.
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 1 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: status not confirmed, as of the sponsor's last update on 19 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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 Mette Korshøj, PhD (004559489851, melars@regionsjaelland.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of musculoskeletal disorders from baseline to 6, 9, 12 and 15 months after randomization (time frame: Data on musculoskeletal disorders are collected 3 months after randomization. Additional follow up data are collected 6, 9, 12 and 15 months after randomization.). The study lists 8 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 NCT05866978, 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 19 May 2023.