Trial document




drksid header

  DRKS00005658

Trial Description

start of 1:1-Block title

Title

Promoting access to rehabilitation

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

PROREHAB

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

The study examines the efficacy of a web-based information portal that addresses persons with a high risk of health-related early retirement to facilitate their access to medical rehabilitation. The website will offer the opportunity to assess the need for rehabilitation in order to promote the intention to apply for a medical rehabilitation of persons with limited work ability and will support handling and submission of the required application documents by a step-by-step instruction. The efficacy of the web-based information portal will be investigated in a controlled trial. Participants will be randomly allocated to two groups: written information on the possibility to use medical rehabilitation including the invitation to use the web-based information vs. written information only. We expect that participants with an access to the web-based information portal apply for and utilise medical rehabilitation services more often than comparable persons who receive written information only.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

In Germany, persons can request medical rehabilitation (MR) to improve work ability and participation in working life. A particular target group of these services are persons with a high risk of health-related early retirement, e.g. persons who received sick leave benefits.
However, if need for rehabilitation does not lead to a formal rehabilitation request, this legal opportunity to keep handicapped people in working life remains unused. In 2011, 59.6 % of all male pensioners and 52.7 % of all female pensioners did not use MR before their health-related early retirement.
In our study, the effects of a web-based information guide on medical rehabilitation, which addresses persons with prior sick leave benefits, will be examined. The theoretical framework of this web-based guide is based on Schwarzer’s Health Action Process Approach. This model distinguishes two phases when realising health-related behaviour: a motivational (forming an intention) and a volitional phase (acting). The website will offer the opportunity to assess the need for rehabilitation by completing the Work Ability Index. In cases of low Work Ability Index scores persons will be advised to apply for a medical rehabilitation. Handling and submission of the required application documents will be supported by a step-by-step instruction.
The efficacy of the web-based information portal will be investigated in a randomised controlled trial. Participants of the intervention group will be informed on the aims of MR and the opportunity to use MR. Additionally, a link to the web-based information will be provided. Participants of the control group will receive a short hint on the opportunity to request this service. We expect that participants who will have access to the web-based information portal apply and use MR more frequently than participants of the control group.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00005658
  •   2014/09/16
  •   [---]*
  •   yes
  •   Approved
  •   2060-2013, Ethikkommission der Medizinischen Hochschule Hannover
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   U1111-1134-6350 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   Persons with sick leave benefits in 2013
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Participants of the intervention group receive a short hint on the possibility to apply for a medical rehabilitation. Additionally, the link to the web-based information portal will be provided.
  •   Participants of the control group receive a short hint on the possibility to apply for a medical rehabilitation.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Health care system
  •   Parallel
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Primary outcome is the proportion of applied and utilised medical rehabilitation services after one year. These data will be extracted from the individual German Pension Insurance (GPI) accounts.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Secondary outcomes are days with sick leave benefits and days of regular employment during the one-year follow-up. These data will be also extracted from the individual GPI accounts. Further secondary outcomes will be assessed by questionnaire after one year. These outcomes include cognitions on rehabilitation and the application (positive and negative outcome expectancies, self-efficacy; own development, see DRKS00004824), indicators of health-related quality of life (subscales of the 36-item Short-Form Health Survey: physical functioning, mental health, general health perception), individual work ability and disability days.

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • other 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2014/09/22
  •   16000
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   40   Years
  •   59   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Persons aged 40 to 59 years with prior sick leave benefits and regular employment of at least six months in the year before the beginning of the study will be included. Samples will be drawn from the registers of three pension insurance agencies (Federal German Pension Insurance, German Pension Insurance Westfalen and German Pension Insurance Rheinland-Pfalz). Sampling will be stratified for pension insurance agency, sex and duration of sick leave benefits.

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

receipt of pension benefits;
receipt of rehabilitation services during the last four years

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Deutsche Rentenversicherung Bund
    • Mr.  Marco  Streibelt 
    • Hohenzollerndamm 46/47
    • 10713  Berlin
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Institut für Sozialmedizin und Epidemiologie
    • Mr.  Prof. Dr.  Matthias  Bethge 
    • Ratzeburger Allee 160
    • 23562  Lübeck
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Deutsche Rentenversicherung Bund
    • Mr.  Dr.  Marco  Streibelt 
    • Hohenzollerndamm 46/47
    • 10713  Berlin
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Deutsche Rentenversicherung Bund
    • Ruhrstraße 2
    • 10704  Berlin
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  •   Spanier K, Streibelt M, Unalan F et al. A web-based intervention to promote applications for rehabilitation: a study protocol for a randomized controlled trial. Trials 2015;16:436; 10.1186/s13063-015-0968-7
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.