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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05817396
Other study ID # K1-2497-GLB-21-V1
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date November 1, 2022
Est. completion date October 31, 2025

Study information

Verified date April 2023
Source University of Erlangen-Nürnberg
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 640
Est. completion date October 31, 2025
Est. primary completion date August 31, 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Promotion of Physical Activity-related Health Competence (PAHCO)
Intervention for the curriculum content "PAHCO" at nursing schools in Bavaria

Locations

Country Name City State
Germany Friedrich-Alexander University Erlangen-Nürnberg Erlangen Bavaria

Sponsors (3)

Lead Sponsor Collaborator
University of Erlangen-Nürnberg Bayerisches Staatsministerium für Gesundheit und Pflege (Bavarian Federal State), Kaufmännische Krankenkasse KKH (Health Insurance)

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
Primary 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)
Primary 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)
Primary 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)
Primary 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)
Primary 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 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)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary 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)
Secondary 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)
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