Trial document




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  DRKS00003115

Trial Description

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Title

Combined preventive measures for jobs partially involving working in shifts - implementation and evaluation study

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Trial Acronym

KomPAS

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URL of the Trial

http://www.uniklinik-freiburg.de/aqms/live/Projekte/Evaluationsforschung/KomPAS.html

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Brief Summary in Lay Language

The German Statutory Pension Insurance Rheinland Pfalz offers a preventive measure against health hazards within the high risk group of shift workers. The measure includes a ten day inpatient phase in a rehabilitation centre, which is followed by an eight week extra occupational phase in outpatient facilities and one refresher day in a rehabilitation centre. This measure is evaluated scientifically.

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Brief Summary in Scientific Language

The German Statutory Pension Insurance Rheinland Pfalz provides a combined measure for jobs that partially involve working in shifts. This is done, to take precautious steps against health hazards within the high risk group of shift workers. Working during changing day and night times has potentially harmful effects on sleep, nutrition behaviour and social context.
The measure KomPAS comprises a ten day inpatient phase in a rehabilitation centre, followed by a 8 week phase in outpatient rehabilitation facilities, and one refresher day in a rehabilitation centre. Apart from an extensive medical examination and classical elements of rehabilitation, such as coping with stress, healthy nutrition and physical exercise are dealt with. This measure is evaluated scientifically.

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Organizational Data

  •   DRKS00003115
  •   2011/05/30
  •   [---]*
  •   no
  •   Approved
  •   117/11, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   Z56 -  Problems related to employment and unemployment
  •   Health hazards of shift workers
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Interventions/Observational Groups

  •   Observational group: 10 day inpatient phase in a rehabilitation centre with classical elements of rehabilitation, 8 week extra occupational phase in outpatient rehabilitation facilities, 1 refresher day in a rehabilitation centre.
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Characteristics

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

Effects of KomPAS, acceptance and satisfaction of program participants. Five time points: at the start of participation, at the end of inpatient rehabilitation, at the end of outpatient rehabilitation, and 6 months, and one year after the start of participation. Assessments: WAI (=Work Ability Index), IRES-24 (IRES=Indicators of Rehabilitation Status), Health-49, EBF (=Erholungs-Belastungs-Fragebogen)

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Secondary Outcome

Sleep quality, fatigue, lack of concentration, recuperation, vegetative symptoms, depression and fear, health hazards, health related quality of life, job satisfaction, ability to work, work disability, accidents at work. Five time points: at the start of participation, at the end of inpatient rehabilitation, at the end of outpatient rehabilitation, and 6 months, and one year after the start of participation. Assessments: WAI (=Work Ability Index), IRES-24 (IRES=Indicators of Rehabilitation Status), Health-49, EBF (=Erholungs-Belastungs-Fragebogen)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2011/05/17
  •   250
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   67   Years
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Additional Inclusion Criteria

Shift workers,working in day/night shifts, who are insured with the German Pension Scheme Rheinland-Pfalz

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Exclusion Criteria

Disability to work for more than six weeks over the last 12 months, serious mental disorder, serious somatic disorder, medical rehabilitation within the last 4 years, insufficient language skills

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Addresses

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    • Universitätsklinikum Freiburg, Abteilung Qualitätsmanagement und Sozialmedizin
    • Mr.  Prof. Dr. med.  Wilfried H.  Jäckel 
    • Engelbergerstr. 21
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg, Abteilung Qualitätsmanagement und Sozialmedizin
    • Mr.  Prof. Dr.  Oskar  Mittag 
    • Engelbergerstr. 21
    • 79106  Freiburg
    • Germany
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    • Universitätsklinikum Freiburg, Abteilung Qualitätsmanagement und Sozialmedizin
    • Ms.  Dr.  Cornelia  Meffert 
    • Engelbergerstr. 21
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Rentenversicherung Rheinland-Pfalz
    • 67340  Speyer
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2014/06/04
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Trial Publications, Results and other Documents

  •   Meffert C, Mittag O, Jäckel WH (2013). Betriebsnahe Präventionsprogramme der Deutschen Rentenversicherung. Die Rehabilitation 52; 391-398
  •   Kampling H, Mittag O, Meffert C, Jäckel WH (2014). Abschlussbericht Projekt "Kombinierte Präventionsleistung für Arbeit mit Schichtanteilen (KomPAS)". AQMS: Universitätsklinikum Freiburg (Fotodruck)
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* This entry means the parameter is not applicable or has not been set.