Trial document




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  DRKS00011309

Trial Description

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Title

Asthma Self-Management at Work: A Mixed Methods Study

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Trial Acronym

[---]*

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URL of the Trial

https://www.uniklinik-duesseldorf.de/fileadmin/Fuer-Patienten-und-Besucher/Kliniken-Zentren-Institute/Institute/Institut_fuer_Arbeits_Sozial_und_Umweltmedizin/Forschung__Arbeits-_und_Sozialmedizin/Project_Asthma_self-management.pdf

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Brief Summary in Lay Language

Asthma can be associated with impairment in patients’ everyday life, such as reduced working ability and employability. The severity of asthma does not only depend on appropriate medical care, but also on the ability to successfully deal with the illness in everyday life (so-called “self-management”). Successful asthma self-management – especially at work – hinges on contextual factors. This project aims at examining the factors that affect successful asthma-self-management at work. Also, potentially promising solutions will be examined.
The planned study consists of several phases: First, by conducting individual interviews we will explore which work-related factors promote or impair effective self-management and which interventions could be promising from the asthma-affected employees’ point of view. Next, a questionnaire will be developed to measure the identified factors which will then be optimized by another round of individual interviews. Eventually, the questionnaire will be filled in by a large group of employees with asthma. Relationships between the identified context factors with asthma self-management as well as other characteristics – like dealing with asthma at the workplace, general asthma control, quality of life and the subjective estimation of work capacity – will be analyzed. Finally, the proposed interventions to improve asthma-relevant working conditions will be evaluated with regard to their meaningfulness und feasibility using moderated discussions with clinicians.

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Brief Summary in Scientific Language

Asthma can be associated with experienced impairment in patients’ everyday life, such as reduced working ability and employability. The severity or prognosis of asthma does not only depend on competent medical care, but also on effective self-management. The successful implementation of disease-self-management in everyday life – especially at work – is contingent upon contextual factors. This project aims at examining a) those determinants of successful asthma-self-management at work as well as b) potentially promising interventions.
The planned study will draw on a sequential-explorative mixed methods design: First, by conducting qualitative interviews we will explore which work-related factors promote or impair effective self-management and which interventions could be promising from the asthma-affected employees’ point of view. Next, a questionnaire will be developed to assess the identified factors which will then be optimized by means of cognitive interviews. Eventually, the questionnaire will be employed in a larger survey and psychometrically examined. In addition, correlations of the identified contextual factors with asthma self-management as well as with secondary outcomes – like asthma-specific morbidity indicators and the subjective prognosis of work capacity – will be examined. Finally, the potential interventions to optimize asthma-relevant working conditions will be evaluated with regard to their meaningfulness und feasibility using structured discussions with clinicians.

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Organizational Data

  •   DRKS00011309
  •   2016/12/22
  •   [---]*
  •   no
  •   Approved
  •   5764R, Ethik-Kommission an der Medizinischen Fakultät der Heinrich-Heine-Universität Düsseldorf
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Secondary IDs

  •   2016116005  ( Registrierungs-ID der HHU Düsseldorf)
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Health Condition or Problem studied

  •   J45 -  Asthma
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Interventions/Observational Groups

  •   The planned study will draw on a sequential-explorative mixed methods design:
    Phase 1: qualitative interviews to explore which work-related factors promote or impair effective self-management and which interventions could be promising from the asthma-affected employees’ point of view
    Phase 2: development of a questionnaire to assess the identified factors
    Phase 3: cognitive interviews to optimize the questionnaire
    Phase 4: survey among asthma patients to assess which work-related factors promote or impair effective self-management as well as the outcomes self-management, asthma control, quality of life, and subjective prognosis of work
    capacity
    Phase 5: group discussions with experts to evaluate the potential interventions to optimize asthma-relevant working conditions with regard to their meaningfulness und feasibility
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Prevention
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

This project aims at examining a) those determinants of successful asthma-self-management at work as well as b) potentially promising interventions. A mixed-methods-design will be used. The quantitative phases base on the results of preceeding qualitative phases.

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Secondary Outcome

/

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
  • Medical Center 
  • Medical Center 
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Recruitment

  •   Actual
  •   2017/01/23
  •   200
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Everybody can participate in this study, who …
•has been diagnosed with asthma by a physician,
•has worked in a insurable employment in the last six months (at least 20 hours per week), and
•has worked in the last six months with the diagnosis “Asthma”.

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Exclusion Criteria

Personens who are self-employed will be excluded from this study as well as patients with a COPD-diagnosis (self-report).

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Addresses

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    • refonetRehabilitations-Forschungsnetzwerkder Deutschen Rentenversicherung Rheinland
    • Postfach 10 07 63
    • 53445  Bad Neuenahr-Ahrweiler
    • Germany
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    • Heinrich-Heine-Universität DüsseldorfInstitut für Arbeits-, Sozial- und Umweltmedizin
    • Ms.  Katherina  Heinrichs 
    • Universitätsstr. 1
    • 40225  Düsseldorf
    • Germany
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    • Heinrich-Heine-Universität DüsseldorfInstitut für Arbeits-, Sozial- und Umweltmedizin
    • Ms.  Katherina  Heinrichs 
    • Universitätsstr. 1
    • 40225  Düsseldorf
    • Germany
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Sources of Monetary or Material Support

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    • refonetRehabilitations-Forschungsnetzwerkder Deutschen Rentenversicherung Rheinland
    • Postfach 10 07 63
    • 53445  Bad Neuenahr-Ahrweiler
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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Trial Publications, Results and other Documents

  •   Heinrichs K, Angerer P, Loerbroks A. Psychosocial working conditions as determinants of asthma self-management at work: A systematic review. Journal of Asthma. 2019;55(10): 1095-1104.
  •   Heinrichs K, Vu-Eickmann P, Hummel S, Gholami J, Loerbroks A. Was erschwert bzw. erleichtert Asthma-Selbstmanagement am Arbeitsplatz?–Eine qualitative Studie. Das Gesundheitswesen. 2017;79(08/09), V-118. Vortrag im Rahmen der Gemeinsamen Jahrestagung der DGEpi, DGMS und DGSMP vom 05. bis 08. September 2017 in Lübeck.
  •   Heinrichs K, Vu-Eickmann P, Hummel S, Gholami J, Loerbroks A. What are the perceived influences on asthma self-management at the workplace? A qualitative study. BMJ Open. 2018;8(8):e022126. Epub 29.08.2018. doi: 10.1136/bmjopen-2018-022126.
  •   Heinrichs K, Vu-Eickmann P, Hummel S, Gholami J, Loerbroks A. Asthma-Selbstmanagement am Arbeitsplatz: Bedingungsfaktoren und Ansatzpunkte möglicher Interventionen – Eine qualitative Studie. Vortrag im Rahmen des Rehabilitationswissenschaftlichen Kolloquiums vom 26. bis 28. Februar 2018 in München.
  •   Heinrichs K, Hummel S, Gholami J, Schultz K, Jian L, Sheikh A, Loerbroks A. Psychosocial working conditions and their association with asthma self-management at work – a cross-sectional study. Vortrag im Rahmen des Kongresses des EFRR vom 15. bis 17. April 2019 in Berlin.
  •   Heinrichs K, Hummel S, Gholami J, Schultz K, Li J, Sheikh A, et al. Psychosocial working conditions, asthma self-management at work and asthma morbidity: a cross-sectional study. Clinical and Translational Allergy. 2019;9(1):25.
  •   Heinrichs K, Hummel S, Gholami J, Schultz K, Wild B, Li J, et al. Psychosocial working conditions and the subjective prognosis of gainful employment among employees with asthma: a cross-sectional study. Disabil Rehabil. (in press).
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* This entry means the parameter is not applicable or has not been set.