Dissemination of Physical Activity-related Health Competence in Vocational Education of Nursing Care (TakeCare!)

April 28, 2026 updated by: Prof. Dr. Klaus Pfeifer, University of Erlangen-Nürnberg

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
335

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bavaria
      • Erlangen, Bavaria, Germany, 91058
        • Friedrich-Alexander University Erlangen-Nürnberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria (School/Cluster Level):

  • 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

Inclusion Criteria (Student Level):

  • Informed written consent to participate (or their legal guardians, if aged under 18 years)
  • Part of the first education year (in cohort 2023/2024)

Exclusion Criteria:

-if any of the criteria mentioned above is not given

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cooperative Planning for Promoting 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.
Behavioral: Promotion of Physical Activity-related Health Competence (PAHCO)
Intervention for the curriculum content "PAHCO" at nursing schools in Bavaria
Experimental: Expert-Based Intervention for Promoting PAHCO Delivered by External Physical Activity Specialists
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.
Behavioral: Promotion of Physical Activity-related Health Competence (PAHCO)
Intervention for the curriculum content "PAHCO" at nursing schools in Bavaria
Experimental: Expert-Based Intervention for Promoting PAHCO Delivered by Teachers
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.
Behavioral: Promotion of Physical Activity-related Health Competence (PAHCO)
Intervention for the curriculum content "PAHCO" at nursing schools in Bavaria
No Intervention: Regular Education and Health Promotion
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Change from baseline (T0) to post-intervention (T2; i.e., one year after the baseline)
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
Change from baseline (T0) to post-intervention (T2; i.e., one year after the baseline)
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)
Change from baseline (T0) to post-intervention (T2; i.e., one year after the baseline)
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
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)
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
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)
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)
Change from baseline (T0) to follow-up (T3; i.e., one year after the end of the intervention, two years after the baseline)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
General Health Status (Short Term)
Time Frame: Change from baseline (T0) to post-intervention (T2; i.e., one year after the baseline)
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
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)
Work Ability Index, short form (WAI-r; Hetzel et al., 2014); higher values (5 min, 36 max) will indicate a better outcome
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)
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
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)
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
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)
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
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)
Work Ability Index, short form (WAI-r; Hetzel et al., 2014); higher values (5 min, 36 max) will indicate a better outcome
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)
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
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)
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
Change from baseline (T0) to follow-up (T3; i.e., one year after the end of the intervention, two years after the baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Erlangen-Nürnberg

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Bayerisches Staatsministerium für Gesundheit und Pflege (Bavarian Federal State)
Kaufmännische Krankenkasse KKH (Health Insurance)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 18, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 20, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 14, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 18, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 29, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • K1-2497-GLB-21-V1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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