Dissemination of Physical Activity-related Health Competence in Vocational Education of Nursing Care

Study Overview
=================
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.

Official Title
-----------------
Take Care! - Dissemination Von Bewegungsbezogener Gesundheitskompetenz in Der Pflegeausbildung

Conditions
-----------------
Physical Activity, Exercise, Education, Nursing, Competence

Intervention / Treatment
-----------------
* Behavioral: Promotion of Physical Activity-related Health Competence (PAHCO)


Participation Criteria
=================
Eligibility Criteria
-----------------
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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Cluster-Randomized Controled Trial (cRCT) with 16 schools
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cooperative Planning for Promoting PAHCO<br>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)<br>* Intervention for the curriculum content PAHCO at nursing schools in Bavaria<br>|
| Experimental: Expert-Based Intervention for Promoting PAHCO Delivered by External Physical Activity Specialists<br>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)<br>* Intervention for the curriculum content PAHCO at nursing schools in Bavaria<br>|
| Experimental: Expert-Based Intervention for Promoting PAHCO Delivered by Teachers<br>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)<br>* Intervention for the curriculum content PAHCO at nursing schools in Bavaria<br>|
| No Intervention: Regular Education and Health Promotion<br>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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nursing Students, Physical-Activity related Health Competence, Implementation, Dissemination, Co-creation, Intervention Development