Trial document




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  DRKS00009000

Trial Description

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Title

The osteoporotic fracture prevention programme in rural areas

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Trial Acronym

OFRA (The Osteoporotic Fracture prevention programme in Rural Areas)

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URL of the Trial

http://www.trittsicher.org

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Brief Summary in Lay Language

The study wants to evaluate a health care fund driven programme, which encourages insured persons to adhere to national guidelines regarding bone health and physical activity/ falls prevention. The health care fund (Sozialversicherung für Landwirtschaft, Forsten und Gartenbau - SVLFG) cooperates with a volunteer organisation of women (LandFrauenverband - dlv) and the German Gymnastics Association (Deutsche Turnerbund - DTB) in order to reduce the burden of osteoporotic fractures.

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Brief Summary in Scientific Language

I. Background and objectives of the study.
Osteoporosis and osteoporotic fractures are one of the leading causes for the loss of autonomy and disability and remain a major health prob-lem in Germany.

The study wants to evaluate a health care fund driven programme to reduce osteoporotic fractures in old people living in rural areas (‘compa-rative effectiveness research’).

The programme “Trittsicher durchs Leben” (OFRA) is in charge of a health care fund (Sozialversicherung für Landwirtschaft, Forsten und Gartenbau - SVLFG). Cooperation partners are a volunteer organisation of women (LandFrauenverband - dlv) and the German Gymnastics Association (Deutsche Turnerbund - DTB). Scientists from the Robert-Bosch-Hospital Stuttgart (Priv. Doz. Dr. Kilian Rapp) and the universities of Ulm (Prof. Dr. D. Rothenbacher) and Hamburg (Prof. Dr. H-H. König) advise the health care fund and perform the evaluation of the programme.

II. Programme Contents.
The programme has 3 components:
1. „Trittsicher“-mobility and fall prevention courses.
2. Examination of bone health.
3. Safety in the living Environment.

III. Implementation of the programme
Logistic.
The implementation of the programme is in charge of the SVLFG. Three telecentres were built up in towns of three different federal states (Stuttgart, Landshut, Kassel). In addition, the SVLFG employs ‚prevention officers‘ who visit the farms regularly. They perform in part the intervention within the programme.

Ad 1.: „Trittsicher“-mobility and fall prevention courses:
Furthermore, the LandFrauenverband and the Deutsche Turnerbund are responsible for the installation of „Trittsicher“-mobility and fall prevention courses in rural areas. The LandFrauen organise the courses, the trainers are physiotherapists or exercise instructors from the DTB. The physiotherapists and exercise instructors get an one-day introduction in the „Trittsicher“-mobility and fall prevention programme.

Ad 2.: Examination of bone health:
The SVLFG and the Association of Statutory Health Insurance Physicians of the participating federal states have closed a contract regulating the reimbursement of the GPs and of the bone density measurement.

IV. Procedures.
A) Identification of insured persons with an increased risk for falls and fractures:
The health insurance fund approaches the following insured persons within the intervention districts:
• community-living women and men aged 70 - <85 years with a fragility fracture in the last 5 years
• community-living women aged 75 - <80 years

B) Recommendation and Action.
The insured persons will be informed about the new programme by a letter. One to four weeks after the letter the insured persons will be approached either by a ‘prevention manager’ at home or by telephone by a member of one of the telecentres.
The insured persons will be motivated to attend a „Trittsicher“-mobility and fall prevention course. The course is free of charge.
Furthermore, a bone density measurement will be recommended. The recommendation is based on the German osteoporosis guidelines of the Dachverband Osteologie (dvo). The bone density measurement (DXA) and an additional fee for the GP will be reimbursed by the programme.
If appropriate the ‘prevention manager’ will give advice about a safe living environment.

The recruitment period lasts over 2 years. It is a cluster-randomised trial (large simple trial), the cluster units are administrative districts. The intervention takes place in 47 intervention districts in 5 federal states (Baden-Württemberg, Bayern, Hessen, Niedersachsen, Rheinland-Pfalz). It is a complete sampling of all at the health care fund insured persons of the above mentioned groups within the intervention districts.

V. Scientific objectives.
The programme wants to reduce osteoporotic fractures by supporting the implementation of recommendations given by guidelines.

Furthermore, the cost effectiveness of the programme will be analysed.

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Organizational Data

  •   DRKS00009000
  •   2015/08/06
  •   [---]*
  •   no
  •   Approved
  •   Antrag-Nr. 120/15, Ethik-Kommission der Universität Ulm
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Secondary IDs

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

  •   S12 -  Fracture of neck
  •   S22 -  Fracture of rib(s), sternum and thoracic spine
  •   S32 -  Fracture of lumbar spine and pelvis
  •   S42 -  Fracture of shoulder and upper arm
  •   S52 -  Fracture of forearm
  •   S72 -  Fracture of femur
  •   S82 -  Fracture of lower leg, including ankle
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Interventions/Observational Groups

  •   Intervention Group:
    Direct approach of selected insured persons who will be 1. motivated to participate in a „Trittsicher“-mobility and fall prevention course. 2. motivated to perform a bone density measurement (DXA). 3. advised about possibilities to improve safety in the living envi-ronment.
    This will be done by a letter to the insured Person; by a first personal contact either by a ‘prevention manager’ at home or by telephone by the staff of one of the telecentres; by one or more additional contacts by telephone by the staff of one of the telecentres; by sending of a final protocol for the insured person including in-formation sheets for the GP and the specialist (with a DXA scanner).
  •   Control Group: no specific therapy
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Control group receives no treatment
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Osteoporotic fractures (ICD-10 S12, S22, S32, S42, S52, S72, S82, kombiniert), which require a hospitalisation (main admission or discharge diagnosis) - as recorded in the routine health claims database of the insurance after recruitment and an additional year of follow-up (30.09.2018).

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Secondary Outcome

1. Attendance of a physical exercise Group, 2. Referral to a bone mass density measurement (DXA), 3. Specific anti-resorptive drug therapy (e.g. bisphosphonates); point 1 to 3 six months after the first contact.
Data collection partly by routine data (DXA; drugs) and partly by as-sessment by the telecentres (attendance of a physical exercise group).
4. Cost-effectiveness of the Programme.
A cost-effectiveness analysis of the programme will be performed one year after the end of recruitment . Based on routine data of the health care fund fracture-related costs of acute care, rehabilitation and care-giving expenses are calculated in the intervention and control group.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2015/10/01
  •   40000
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   70   Years
  •   84   Years
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Additional Inclusion Criteria

All …
• community-living women and men aged 70- <85 years with a fragility fracture in the last 5 years;
• community-living women aged 75- <80 years
… who are insured at the Landwirtschaftliche Krankenversicherung (LKK) within the Sozialversicherung für Landwirtschaft, Forsten und Gartenbau (SVLFG) and live in one of the intervention districts (complete sampling).

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Exclusion Criteria

1. Insured persons not living at home (residents of nursing homes). 2. Insured persons with being categorized in a level of care 2 or 3 (Pflegestufe 2 oder 3) according to the German long term care insurance.

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Addresses

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    • Robert Bosch Gesellschaft für medizinische Forschung mbH (RBMF)
    • Auerbachstraße 112
    • 70376  Stuttgart
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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    • Institut für Epidemiologie und Medizinische Biometrie
    • Mr.  Prof. Dr.  Dietrich  Rothenbacher 
    • Helmholtzstr. 22
    • 89081  Ulm
    • Germany
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    • Universitätsklinikum Hamburg-EppendorfInstitut für Gesundheitsökonomie und Versorgungsforschung
    • Mr.  Prof. Dr.  Hans-Helmut  König 
    • Martinistr. 52
    • 20246  Hamburg
    • Germany
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    • Klinik für Geriatrische Rehabilitation am Robert-Bosch-Krankenhaus
    • Mr.  Priv. Doz. Dr.  Kilian  Rapp 
    • Auerbachstraße 110
    • 70376  Stuttgart
    • Germany
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    • Sozialversicherung für Landwirtschaft, Forsten und Gartenbau (SVLFG)
    • Ms.  Andrea  Papadopoulos 
    • Dr.-Georg-Heim-Allee 1
    • 84036  Landshut
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung (BMBF)
    • Kapelle-Ufer 1
    • 10117  Berlin
    • Germany
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Status

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

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* This entry means the parameter is not applicable or has not been set.