NCT05817396

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
335

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 18, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

April 18, 2023

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2025

Completed
Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

2.2 years

First QC Date

March 14, 2023

Last Update Submit

April 28, 2026

Conditions

Keywords

Nursing StudentsPhysical-Activity related Health CompetenceImplementationDisseminationCo-creationIntervention Development

Outcome Measures

Primary Outcomes (6)

  • 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

    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

    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)

    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

    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

    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)

    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)

    Change from baseline (T0) to post-intervention (T2; i.e., one year after the baseline)

  • Work Ability (Short Term)

    Change from baseline (T0) to post-intervention (T2; i.e., one year after the baseline)

  • Musculoskeletal Complaints (Short Term)

    Change from baseline (T0) to post-intervention (T2; i.e., one year after the baseline)

  • Physical Job Stress in Nursing (Short Term)

    Change from baseline (T0) to post-intervention (T2; i.e., one year after the baseline)

  • General Health Status (Medium Term)

    Change from baseline (T0) to follow-up (T3; i.e., one year after the end of the intervention, two years after the baseline)

  • +3 more secondary outcomes

Study Arms (4)

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.

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.

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.

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".

Interventions

Intervention for the curriculum content "PAHCO" at nursing schools in Bavaria

Cooperative Planning for Promoting PAHCOExpert-Based Intervention for Promoting PAHCO Delivered by External Physical Activity SpecialistsExpert-Based Intervention for Promoting PAHCO Delivered by Teachers

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • if any of the criteria mentioned above is not given

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Friedrich-Alexander University Erlangen-Nürnberg

Erlangen, Bavaria, 91058, Germany

Location

Related Publications (2)

  • 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.

  • Carl 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.

Related Links

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Cluster-Randomized Controled Trial (cRCT) with 16 schools
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair Lead

Study Record Dates

First Submitted

March 14, 2023

First Posted

April 18, 2023

Study Start

April 18, 2023

Primary Completion

June 20, 2025

Study Completion

July 31, 2025

Last Updated

April 29, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations