Trial document



drksid header

  DRKS00011554

Trial Description

start of 1:1-Block title

Title

Rehabilitation access and effectiveness cohort study for persons with back pain

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

Trial Acronym

REHAB-BP

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

URL of the Trial

http://www.rehab-bp.de/de/

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

Brief Summary in Lay Language

The German Pension Insurance provides medical rehabilitation services with the aim of improving or restoring work ability. Musculoskeletal disorders, especially back pain, are the main reasons for medical rehabilitation. Evidence on access barriers to rehabilitation and the effectiveness of medical rehabilitation in patients with back pain is unclear. Therefore the aim of the study is two-fold: first to analyse access barriers to medical rehabilitation services, and second, to examine the effectiveness of medical rehabilitation services in Germany. To answer these questions, persons, who are registered in the German Pension Insurance, will be surveyed in 2017 and 2019. Survey data will be linked to administrative data on utilised rehabilitation services. The sample includes employed persons aged 45 to 59 years.

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

Brief Summary in Scientific Language

In cases of limited work ability or when work ability is at risk, people can apply for medical rehabilitation services. The German Pension Insurance provides these services with the aim of improving or restoring the work ability. Musculoskeletal diseases, especially back pain, are the main reasons for medical rehabilitation. The appropriate access to rehabilitation according to the actual needs of patients is currently an issue that is critically discussed. Frequently, the need for rehabilitation does not lead to a rehabilitation request. Despite the maxim “rehabilitation before pension”, every second person who receives a disability pension did not participate in rehabilitation services before the pension was granted. However, there are no up-to-date studies that have examined rehabilitation barriers. Moreover, randomised controlled trials that compared persons with and without rehabilitation participation have generated contradictory findings regarding the effects of medical rehabilitation. However, the setting of these studies was restricted to single centres or particular regions. There is currently no evidence on the effectiveness of rehabilitation services under routine conditions.
Therefore the study analyses firstly the access barriers to medical rehabilitation services. Secondly, the study examines the effectiveness of German medical rehabilitation services.
The cohort study will identify persons with back pain and then compare back pain patients who completed a medical rehabilitation with back pain patients without utilising a medical rehabilitation program. The primary outcome is pain disability in important life domains (work, daily living and leisure time). To analyse the effectiveness of medical rehabilitation services, participants and non-participants will be matched by the probability of treatment, i.e. to participate in a medical rehabilitation program (propensity score matching). The samples will be drawn from the registers of two pension insurance agencies (German Pension Insurance North: n = 22,500; German Pension Insurance Central Germany: n = 22,500). We will include employed people aged 45 to 59 years. Persons who requested or utilised medical rehabilitation services during the past four years and persons with requested or approved disability pensions will be excluded. Data are assessed by written surveys in 2017 and 2019. Additionally, administrative date will be extracted.

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

Do you plan to share individual participant data with other researchers?

[---]*

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

[---]*

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00011554
  •   2017/01/26
  •   [---]*
  •   yes
  •   Approved
  •   15-144, Ethik-Kommission Universität zu Lübeck Medizinische Fakultät des Universitätsklinikums Schleswig-Holstein
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   U1111-1162-7501 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   M40-M54 -  Dorsopathies
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Medical rehabilitation services (utilisation as derived from the German Pension Insurance accounts)
  •   No medical rehabilitation
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Control group receives no treatment
  •   Treatment
  •   Parallel
  •   IV
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Pain disability: 3 items assess the impairments in everyday life, leisure time and at work with values ranging from 0 to 100. Higher values indicate higher impairments. The primary outcome will be assessed by questionnaire at baseline (2017) and follow-up (2019).

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

Secondary Outcome

The following secondary outcomes will be assessed by questionnaire at baseline and follow-up:
- pain intensity (0 to 100 points) and disability days: German version of the Chronic Pain Grade (Klasen et al. 2004)
- pain self-efficacy (10 to 60 points): German adaption of the Pain Self-efficacy Questionnaire (FESS) (Mangels et al. 2009)
- fear avoidance beliefs: adapted version of two subscales (physical activity, 0 to 18 points; work as cause of pain, 0 to 18 points) of the German version of the Fear Avoidance Belief Questionnaire (FABQ) (Pfingsten et al. 1997)
- self-rated health (0 to 10 points): adapted version of the single index value for health status of the EQ-5D (Rabin and de Charro 2001)
- depressive symptoms (0 to 24 points): 8-item depression module of the Patient Health Questionnaire (PHQ-8) (Gräfe et al. 2004)
- self-rated work ability (0 to 10 points): Work Ability Score (WAS) (Ilmarinen 2007)
- self-rated prognosis of employability (0 to 3 points): 3 item scale (Mittag and Raspe 2003)
- healthcare utilisation: use of pharmaceuticals, visits to physicians, outpatient therapy (e.g. physiotherapy), days of hospitalisation, and days of sick leave

The following secondary outcomes will be extracted from the pension insurance accounts for 2016 and 2018:
- days in receipt of sickness absence benefits
- days in regular employment
- disability pensions

For estimating the propensity scores, additional measures will be assessed only at baseline:
- comorbidity (0 to 15 points): adapted version of the German version of the Self-Administered Comorbidity Questionnaire (SCQ-D) (Streibelt et al. 2012)
- health behaviour: physical exercise, smoking, and body mass index
- socio-demographic data: migration, educational level, job position, net income, partnership, number of household members, number of children (<14 years), family members with a special need of care, strain due to home and family work (2 items with values ranging from 0 to 10) (Worringen and Benecke 2001)
- work environment: occupation, profession, fixed-term job contracts, shift work, size of enterprise,
- physical job demands (0 to 15 points) (Slesina 1987)
- measures of the Copenhagen Psychosocial Questionnaire (COPSOQ) (0 to 100 points): psychological job demands, support by supervisor and colleagues, atmosphere at work, job insecurity, overall job satisfaction (Nuebling and Hasselhorn 2010)
- mobbing (Institut für Arbeitsmarkt- und Berufsforschung 1999)

To assess cognitions about and experiences with rehabilitation services, additional variables will be assessed at baseline and follow-up (Spanier et al. 2016):
- former medical rehabilitation services
- subjective need for rehabilitation
- intention to apply for medical rehabilitation
- knowledge on rehabilitation application procedures
- outcome expectations
- social support by family/friends and physicians/therapists

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

  • [---]*
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2017/03/23
  •   45000
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

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

Additional Inclusion Criteria

Persons will be included if they are employed.

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

Exclusion Criteria

Persons who requested or utilised medical rehabilitation services during the past four years and persons with requested or approved disability pensions will be excluded.

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • Universität zu Lübeck, Institut für Sozialmedizin und Epidemiologie, Sektion Rehabilitation und Arbeit
    • Mr.  Prof. Dr.  Matthias  Bethge 
    • Ratzeburger Allee 160
    • 23562  Lübeck
    • 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 primary-sponsor
    • Martin-Luther-Universität Halle-Wittenberg, Medizinische Fakultät, Institut für Rehabilitationsmedizin
    • Mr.  Prof. Dr.  Wilfried  Mau 
    • Magdeburger Straße 8
    • 06112  Halle
    • 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 other
    • Martin-Luther-Universität Halle-Wittenberg, Medizinische Fakultät, Institut für Rehabilitationsmedizin
    • Magdeburger Straße 8
    • 06112  Halle
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact other
  • start of 1:1-Block address other
    • Deutsche Rentenversicherung Nord
    • Ziegelstraße 150
    • 23556  Lübeck
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact other
  • start of 1:1-Block address other
    • Deutsche Rentenversicherung Mitteldeutschland
    • Paracelsusstraße 21
    • 06114  Halle
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact other
  • start of 1:1-Block address scientific-contact
    • Universität zu Lübeck, Institut für Sozialmedizin und Epidemiologie, Sektion Rehabilitation und Arbeit
    • 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 scientific-contact
    • Martin-Luther-Universität Halle-Wittenberg, Medizinische Fakultät, Institut für Rehabilitationsmedizin
    • Mr.  Prof. Dr.  Wilfried  Mau 
    • Magdeburger Straße 8
    • 06112  Halle
    • 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
    • Universität zu Lübeck, Institut für Sozialmedizin und Epidemiologie, Sektion Rehabilitation und Arbeit
    • Mr.  David  Fauser 
    • Ratzeburger Allee 160
    • 23562  Lübeck
    • 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
  • start of 1:1-Block address public-contact
    • Martin-Luther-Universität Halle-Wittenberg, Medizinische Fakultät, Institut für Rehabilitationsmedizin
    • Ms.  Dr.  Kerstin  Mattukat 
    • Magdeburger Straße 8
    • 06112  Halle
    • 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 Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • 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 complete, follow-up continuing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.