Physical ActivityTakeCare!NCT05817396
Dissemination of Physical Activity-related Health Competence in Vocational Education of Nursing Care
A study testing Promotion of Physical Activity-related Health Competence (PAHCO) in people with Physical Activity and Exercise, run by University of Erlangen-Nürnberg at 1 site in Germany.
Trial summary
The "TakeCare!" study addresses the problem that vocational students of nursing care cope with great physical and psychological demands during their daily routines. To meet these demands, the Bavarian curriculum for generalist nurses has adopted the promotion of physical activity-related health competence (PAHCO) for… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Physical Activity, Exercise, Education
- What is being tested?
- Promotion of Physical Activity-related Health Competence (PAHCO)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 335 participants
- Where
- 1 siteGermany
- Study dates
- 18 Apr 2023to 31 Jul 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Private or Local Sponsorship
- Location in Bavaria
- Schools with 33-64 students in the first cohort (i.e., two or three classes per cohort)
- School director providing informed written consent by March 1st 2023
- Informed written consent to participate (or their legal guardians, if aged under 18 years)
- Part of the first education year (in cohort 2023/2024)
Who cannot join
- -if any of the criteria mentioned above is not given
Trial locations and contacts
1 site in 1 country.
Germany1 site
Friedrich-Alexander University Erlangen-Nürnberg
Erlangen, Bavaria, 91058
About this study
Official title: Take Care! - Dissemination Von Bewegungsbezogener Gesundheitskompetenz in Der Pflegeausbildung
The "TakeCare!" study addresses the problem that vocational students of nursing care cope with great physical and psychological demands during their daily routines. To meet these demands, the Bavarian curriculum for generalist nurses has adopted the promotion of physical activity-related health competence (PAHCO) for vocational students. However, it must be assumed that the concept has not yet been adopted comprehensively across the Bavarian nursing landscape. Therefore, the "TakeCare!" study tackles the question of how PAHCO can be implemented most appropriately in Bavarian nursing schools. Drawing on experiences from the project PArC-AVE, three different dissemination approaches will being tested and compared with a control group. A total of 16 nursing schools from different regions of Bavaria will be assigned to four different study arms (cluster-randomized design). In the long term, the project aims to derive recommendations for all nursing schools in Bavaria.
- Conditions
- Physical Activity, Exercise, Education, Nursing, Competence
- Being tested
- Promotion of Physical Activity-related Health Competence (PAHCO)
- Keywords
- Nursing Students, Physical-Activity related Health Competence, Implementation, Dissemination, Co-creation, Intervention Development
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Promotion of Physical Activity-related Health Competence (PAHCO)Behavioural
Intervention for the curriculum content "PAHCO" at nursing schools in Bavaria
| Study group | Role | What they receive |
|---|---|---|
| Cooperative Planning for Promoting PAHCO | Experimental | Participatively developed intervention concept by means of cooperative planning (Rütten, 1997) to promote physical activity-related health competence (PAHCO): A separate cooperative planning process will take place in each of the four schools in this study arm from April to November 2023. Within the framework of these processes, suitable interventions tailored to the target group and the school will be developed for the implementation of the curriculum content "PAHCO" with the participation of actors from science and practice (e.g., teachers, nursing students of the schools). The developed interventions will be implemented from December 2023 under the responsibility of the actors in the schools. Receives: Behavioral: Promotion of Physical Activity-related Health Competence (PAHCO) |
| Expert-Based Intervention for Promoting PAHCO Delivered by External Physical Activity Specialists | Experimental | Expert-based intervention concept with external physical activity specialists to promote physical activity-related health competence (PAHCO). We will develop a specific intervention concept for the implementation of the curriculum content "PAHCO" at nursing schools in Bavaria from April to November 2023. Currently (March 2022), it is planned that the intervention will comprise 12 sessions with a duration of 45 or 90 minutes. The entire intervention will be specified during the different steps of intervention mapping (i.e., needs assessment, goal formulation, screening evidence-based intervention content). Physical activity specialists (e.g. sports scientists, physiotherapists) will be trained to implement this expert-based intervention concept from December 2023 to March 2024. Receives: Behavioral: Promotion of Physical Activity-related Health Competence (PAHCO) |
| Expert-Based Intervention for Promoting PAHCO Delivered by Teachers | Experimental | Expert-based intervention concept with teachers as multipliers to promote physical activity-related health competence (PAHCO). We will develop a specific intervention concept for the implementation of the curriculum content "PAHCO" at nursing schools in Bavaria from April to November 2023. Currently (March 2022), it is planned that the intervention will comprise 12 sessions with a duration of 45 or 90 minutes. The entire intervention will be specified during the different steps of intervention mapping (i.e., needs assessment, goal formulation, screening evidence-based intervention content). Teachers of the participating nursing schools of this study arm will be trained to implement this expert-based intervention concept in their school from December 2023 to March 2024. Receives: Behavioral: Promotion of Physical Activity-related Health Competence (PAHCO) |
| Regular Education and Health Promotion | No intervention | No systematic intervention concept: In the schools of this study arm, there is no systematic and scientifically supported intervention for the implementation of the curriculum content "PAHCO". |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Activity-related Health Competence (Short Term)
Physical Activity-related Health Competence (PAHCO) Questionnaire (Carl et al., 2020); higher percentage scores (0 min, 100 max) indicate a better outcome
Measured: Change from baseline (T0) to post-intervention (T2; i.e., one year after the baseline)
Psychological Movement Quality (Short Term)
Physical Activity Enjoyment Scale (PACES; Jekauc et al., 2020); higher scores (16 min, 80 max) indicate a better outcome
Measured: Change from baseline (T0) to post-intervention (T2; i.e., one year after the baseline)
Quality Physical Activity (Short Term)
The outcome is a relational aggregate index between leisure time physical activity and occupational physical activity; higher values (i.e., higher leisure time physical activity relative to occupational physical activity) indicate a better outcome; Leisure time physical activity via BSA Questionnaire (Fuchs et al., 2015); Occupational sitting and physical activity questionnaire (OSPAQ; Chau et al., 2012)
Measured: Change from baseline (T0) to post-intervention (T2; i.e., one year after the baseline)
Physical Activity-related Health Competence (Medium Term)
Physical Activity-related Health Competence (PAHCO) Questionnaire (Carl et al., 2020); higher percentage scores (0 min, 100 max) indicate a better outcome
Measured: Change from baseline (T0) to follow-up (T3; i.e., one year after the end of the intervention, two years after the baseline)
Psychological Movement Quality (Medium Term)
Physical Activity Enjoyment Scale (PACES; Jekauc et al., 2020); higher scores (16 min, 80 max) indicate a better outcome
Measured: Change from baseline (T0) to follow-up (T3; i.e., one year after the end of the intervention, two years after the baseline)
Quality Physical Activity (Medium Term)
The outcome is a relational aggregate index between leisure time physical activity and occupational physical activity; higher values (i.e., higher leisure time physical activity relative to occupational physical activity) indicate a better outcome; Leisure time physical activity via BSA Questionnaire (Fuchs et al., 2015); Occupational sitting and physical activity questionnaire (OSPAQ; Chau et al., 2012)
Measured: Change from baseline (T0) to follow-up (T3; i.e., one year after the end of the intervention, two years after the baseline)
Secondary outcomes (8)
General Health Status (Short Term)
Single-Item (#1) of the Short-Form-Health-Survey (SF-12; Morfeld et al., 2011); after inversion, higher values (0 min, 4 max) will indicate a better outcome
Measured: Change from baseline (T0) to post-intervention (T2; i.e., one year after the baseline)
Work Ability (Short Term)
Work Ability Index, short form (WAI-r; Hetzel et al., 2014); higher values (5 min, 36 max) will indicate a better outcome
Measured: Change from baseline (T0) to post-intervention (T2; i.e., one year after the baseline)
Musculoskeletal Complaints (Short Term)
Ten items (neck/cervical spine, shoulder joints, ellbow/lower arms, hands, thoracic spine, lower back, hip joints/thighs, knee joints, lower legs, feet) of the Nordic Musculosceletal Questionnaire (NMQ; Bundesanstalt für Arbeitsschutz und Arbeitsmedizin, 2021); lower values will indicate a better outcome
Measured: Change from baseline (T0) to post-intervention (T2; i.e., one year after the baseline)
Physical Job Stress in Nursing (Short Term)
Self-developed questionnaire for the physical job stress in nursing; instrument (at its early stage) currently comprises 30 items, will undergo psychometric validation at baseline (T0), lower values (min 0, max 4 for each item) will indicate a better outcome
Measured: Change from baseline (T0) to post-intervention (T2; i.e., one year after the baseline)
General Health Status (Medium Term)
Single-Item (#1) of the Short-Form-Health-Survey (SF-12; Morfeld et al., 2011); after inversion, higher values (0 min, 4 max) will indicate a better outcome
Measured: Change from baseline (T0) to follow-up (T3; i.e., one year after the end of the intervention, two years after the baseline)
Work Ability (Medium Term)
Work Ability Index, short form (WAI-r; Hetzel et al., 2014); higher values (5 min, 36 max) will indicate a better outcome
Measured: Change from baseline (T0) to follow-up (T3; i.e., one year after the end of the intervention, two years after the baseline)
Musculoskeletal Complaints (Medium Term)
Ten items (neck/cervical spine, shoulder joints, ellbow/lower arms, hands, thoracic spine, lower back, hip joints/thighs, knee joints, lower legs, feet) of the Nordic Musculosceletal Questionnaire (NMQ; Bundesanstalt für Arbeitsschutz und Arbeitsmedizin, 2021); lower values will indicate a better outcome
Measured: Change from baseline (T0) to follow-up (T3; i.e., one year after the end of the intervention, two years after the baseline)
Physical Job Stress in Nursing (Medium Term)
Self-developed questionnaire for the physical job stress in nursing; instrument (at its early stage) currently comprises 30 items, will undergo psychometric validation at baseline (T0), lower values (min 0, max 4 for each item) will indicate a better outcome
Measured: Change from baseline (T0) to follow-up (T3; i.e., one year after the end of the intervention, two years after the baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start18 Apr 2023
- Primary completion20 Jun 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Physical ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster-Randomized Controled Trial (cRCT) with 16 schools
- Masking
- None (open label)
- Enrolment
- 335 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg
- Sponsor type
- University, hospital or other
- Collaborators
- Bayerisches Staatsministerium für Gesundheit und Pflege (Bavarian Federal State), Kaufmännische Krankenkasse KKH (Health Insurance)
- Responsible party
- Principal investigator, Prof. Dr. Klaus Pfeifer, University of Erlangen-Nürnberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05817396
- Sponsor's protocol ID
- K1-2497-GLB-21-V1
- Acronym
- TakeCare!
- Status last verified
- Apr 2026
- First submitted
- 14 Mar 2023
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lorenz E, Grune E, Popp J, Pfeifer K, Carl J. Focus group-supported development and psychometric exploration of an instrument to assess perceived physical exertion in nursing students. BMC Nurs. 2024 Dec 30;23(1):957. doi: 10.1186/s12912-024-02639-9.
PubMed 39736619Carl J, Grune E, Popp J, Hartung V, Pfeifer K. Implementation and dissemination of physical activity-related health competence in vocational nursing training: study protocol for a cluster-randomized controlled intervention trial. Trials. 2024 May 15;25(1):322. doi: 10.1186/s13063-024-08153-2.
PubMed 38750590
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Take Care! - Dissemination Von Bewegungsbezogener Gesundheitskompetenz in Der Pflegeausbildung
- ClinicalTrials.gov ID
- NCT05817396
- Acronym / sponsor ID
- TakeCare! / K1-2497-GLB-21-V1
- Conditions
- Physical Activity, Exercise, Education, Nursing, Competence
- Keywords
- Nursing Students, Physical-Activity related Health Competence, Implementation, Dissemination, Co-creation, Intervention Development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 335 participants (actual)
- Lead sponsor
- University of Erlangen-NürnbergUniversity, hospital or other
- Collaborators
- Bayerisches Staatsministerium für Gesundheit und Pflege (Bavarian Federal State), Kaufmännische Krankenkasse KKH (Health Insurance)
- Study start
- 18 Apr 2023 (actual)
- Primary completion
- 20 Jun 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 18 Apr 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 "TakeCare!" study addresses the problem that vocational students of nursing care cope with great physical and psychological demands during their daily routines. To meet these demands, the Bavarian curriculum for generalist nurses has adopted the promotion of physical activity-related health competence (PAHCO) for vocational students. However, it must be assumed that the concept has not yet been adopted comprehensively across the Bavarian nursing landscape. Therefore, the "TakeCare!" study tackles the question of how PAHCO can be implemented most appropriately in Bavarian nursing schools. Drawing on experiences from the project PArC-AVE, three different dissemination approaches will being tested and compared with a control group. A total of 16 nursing schools from different regions of Bavaria will be assigned to four different study arms (cluster-randomized design). In the long term, the project aims to derive recommendations for all nursing schools in Bavaria.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Cluster-Randomized Controled Trial (cRCT) with 16 schools
| Arm | Type | Receives |
|---|---|---|
| Cooperative Planning for Promoting PAHCO | Experimental | Behavioral: Promotion of Physical Activity-related Health Competence (PAHCO)Participatively developed intervention concept by means of cooperative planning (Rütten, 1997) to promote physical activity-related health competence (PAHCO): A separate cooperative planning process will take place in each of the four schools in this study arm from April to November 2023. Within the framework of these processes, suitable interventions tailored to the target group and the school will be developed for the implementation of the curriculum content "PAHCO" with the participation of actors from science and practice (e.g., teachers, nursing students of the schools). The developed interventions will be implemented from December 2023 under the responsibility of the actors in the schools. |
| Expert-Based Intervention for Promoting PAHCO Delivered by External Physical Activity Specialists | Experimental | Behavioral: Promotion of Physical Activity-related Health Competence (PAHCO)Expert-based intervention concept with external physical activity specialists to promote physical activity-related health competence (PAHCO). We will develop a specific intervention concept for the implementation of the curriculum content "PAHCO" at nursing schools in Bavaria from April to November 2023. Currently (March 2022), it is planned that the intervention will comprise 12 sessions with a duration of 45 or 90 minutes. The entire intervention will be specified during the different steps of intervention mapping (i.e., needs assessment, goal formulation, screening evidence-based intervention content). Physical activity specialists (e.g. sports scientists, physiotherapists) will be trained to implement this expert-based intervention concept from December 2023 to March 2024. |
| Expert-Based Intervention for Promoting PAHCO Delivered by Teachers | Experimental | Behavioral: Promotion of Physical Activity-related Health Competence (PAHCO)Expert-based intervention concept with teachers as multipliers to promote physical activity-related health competence (PAHCO). We will develop a specific intervention concept for the implementation of the curriculum content "PAHCO" at nursing schools in Bavaria from April to November 2023. Currently (March 2022), it is planned that the intervention will comprise 12 sessions with a duration of 45 or 90 minutes. The entire intervention will be specified during the different steps of intervention mapping (i.e., needs assessment, goal formulation, screening evidence-based intervention content). Teachers of the participating nursing schools of this study arm will be trained to implement this expert-based intervention concept in their school from December 2023 to March 2024. |
| Regular Education and Health Promotion | No intervention | –No systematic intervention concept: In the schools of this study arm, there is no systematic and scientifically supported intervention for the implementation of the curriculum content "PAHCO". |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Private or Local Sponsorship
- Location in Bavaria
- Schools with 33-64 students in the first cohort (i.e., two or three classes per cohort)
- School director providing informed written consent by March 1st 2023
- Informed written consent to participate (or their legal guardians, if aged under 18 years)
Key exclusion criteria (1 listed)
- -if any of the criteria mentioned above is not given
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 |
|---|---|---|
| Promotion of Physical Activity-related Health Competence (PAHCO)Intervention for the curriculum content "PAHCO" at nursing schools in Bavaria | Behavioural | Cooperative Planning for Promoting PAHCO, Expert-Based Intervention for Promoting PAHCO Delivered by External Physical Activity Specialists, Expert-Based Intervention for Promoting PAHCO Delivered by Teachers |
Primary outcome
Physical Activity-related Health Competence (Short Term)
Time frame: Change from baseline (T0) to post-intervention (T2; i.e., one year after the baseline)
Physical Activity-related Health Competence (PAHCO) Questionnaire (Carl et al., 2020); higher percentage scores (0 min, 100 max) indicate a better outcome
Psychological Movement Quality (Short Term)
Time frame: Change from baseline (T0) to post-intervention (T2; i.e., one year after the baseline)
Physical Activity Enjoyment Scale (PACES; Jekauc et al., 2020); higher scores (16 min, 80 max) indicate a better outcome
Quality Physical Activity (Short Term)
Time frame: Change from baseline (T0) to post-intervention (T2; i.e., one year after the baseline)
The outcome is a relational aggregate index between leisure time physical activity and occupational physical activity; higher values (i.e., higher leisure time physical activity relative to occupational physical activity) indicate a better outcome; Leisure time physical activity via BSA Questionnaire (Fuchs et al., 2015); Occupational sitting and physical activity questionnaire (OSPAQ; Chau et al., 2012)
Physical Activity-related Health Competence (Medium Term)
Time frame: Change from baseline (T0) to follow-up (T3; i.e., one year after the end of the intervention, two years after the baseline)
Physical Activity-related Health Competence (PAHCO) Questionnaire (Carl et al., 2020); higher percentage scores (0 min, 100 max) indicate a better outcome
Psychological Movement Quality (Medium Term)
Time frame: Change from baseline (T0) to follow-up (T3; i.e., one year after the end of the intervention, two years after the baseline)
Physical Activity Enjoyment Scale (PACES; Jekauc et al., 2020); higher scores (16 min, 80 max) indicate a better outcome
Quality Physical Activity (Medium Term)
Time frame: Change from baseline (T0) to follow-up (T3; i.e., one year after the end of the intervention, two years after the baseline)
The outcome is a relational aggregate index between leisure time physical activity and occupational physical activity; higher values (i.e., higher leisure time physical activity relative to occupational physical activity) indicate a better outcome; Leisure time physical activity via BSA Questionnaire (Fuchs et al., 2015); Occupational sitting and physical activity questionnaire (OSPAQ; Chau et al., 2012)
8 secondary outcomes
General Health Status (Short Term)
Time frame: Change from baseline (T0) to post-intervention (T2; i.e., one year after the baseline)
Work Ability (Short Term)
Time frame: Change from baseline (T0) to post-intervention (T2; i.e., one year after the baseline)
Musculoskeletal Complaints (Short Term)
Time frame: Change from baseline (T0) to post-intervention (T2; i.e., one year after the baseline)
Physical Job Stress in Nursing (Short Term)
Time frame: Change from baseline (T0) to post-intervention (T2; i.e., one year after the baseline)
General Health Status (Medium Term)
Time frame: Change from baseline (T0) to follow-up (T3; i.e., one year after the end of the intervention, two years after the baseline)
Work Ability (Medium Term)
Time frame: Change from baseline (T0) to follow-up (T3; i.e., one year after the end of the intervention, two years after the baseline)
Musculoskeletal Complaints (Medium Term)
Time frame: Change from baseline (T0) to follow-up (T3; i.e., one year after the end of the intervention, two years after the baseline)
Physical Job Stress in Nursing (Medium Term)
Time frame: Change from baseline (T0) to follow-up (T3; i.e., one year after the end of the intervention, two years after the baseline)
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 29 Apr 2026.
- Derived from this study: PubMed 39736619Lorenz E, Grune E, Popp J, Pfeifer K, Carl J. Focus group-supported development and psychometric exploration of an instrument to assess perceived physical exertion in nursing students. BMC Nurs. 2024 Dec 30;23(1):957. doi: 10.1186/s12912-024-02639-9.
- Derived from this study: PubMed 38750590Carl J, Grune E, Popp J, Hartung V, Pfeifer K. Implementation and dissemination of physical activity-related health competence in vocational nursing training: study protocol for a cluster-randomized controlled intervention trial. Trials. 2024 May 15;25(1):322. doi: 10.1186/s13063-024-08153-2.
- Project description on university websiteLink provided by the sponsor.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Promotion of Physical Activity-related Health Competence (PAHCO) in people with Physical Activity and Exercise, run by University of Erlangen-Nürnberg at 1 site in Germany.
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 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: finished, as of the sponsor's last update on 29 Apr 2026. 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 Germany. 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?
Physical Activity-related Health Competence (Short Term) (time frame: Change from baseline (T0) to post-intervention (T2; i.e., one year after the baseline)). The study lists 6 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 NCT05817396, which also lists 2 linked publications.
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 29 Apr 2026.