Trial document

drksid header

DRKS-ID: DRKS00006188

Trial Description

start of 1:1-Block title

Title

Development, implementation, and Evaluation of a rehabilitation-linked, standardized continuing education concept in general practioner quality circles.

end of 1:1-Block title

start of 1:1-Block acronym

Trial Acronym

[---]*

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 background of the study is, that the general practitioner is the first contact for patients with chronical diseases. Their task is it, to evaluate the possible need for rehabilitation to identify, to advise patients about this and to introduce first steps. That is often a big problem in general practice. The target of the study is the
elaboration of a specific education program for general practioners for possibilities in rehabilitation for patients in general practice.
This education program sensibilize general practitioners for rehabilitation. The primary goal of the study is the comparison of the rate of successful requests of rehabilitation over 6 months before and 6 months after the medical education (intervention).

end of 1:1-Block public summary

start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Elaboration of a specific education program for possibilities in rehabilitation for patients in primary care.

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

DRKS-ID: DRKS00006188
Date of Registration in DRKS: 2014/10/02
Date of Registration in Partner Registry or other Primary Registry: [---]*
Investigator Sponsored/Initiated Trial (IST/IIT): yes
Ethics Approval/Approval of the Ethics Committee: Approved
(leading) Ethics Committee No.: 2014-13, Ethikkommission der Medizinischen Fakultät der Martin-Luther-Universität Halle Wittenberg

end of 1:1-Block organizational data

start of 1:n-Block secondary IDs

Secondary IDs

Universal Trial Number (UTN): U1111-1158-8334

end of 1:n-Block secondary IDs

start of 1:N-Block indications

Health Condition or Problem studied

Free text: orthopedic diseases, cardiovasculare diseases, mental diseases, psychosomatic diseases, cancer

end of 1:N-Block indications

start of 1:N-Block interventions

Interventions/Observational Groups

Arm 1: Before intervention: Family doctors in Saxony-Anhalt before participation in the specific medical education program of this trial (control)
Arm 2: After intervention: Family doctors in Saxony-Anhalt after participation in the specific medical education program of this Trial (intervention). This is a pre-post design.

end of 1:N-Block interventions

start of 1:1-Block design

Characteristics

Study Type: Interventional
Study Type Non-Interventional: [---]*
Allocation: Other
Blinding: Open (masking not used)
Who is blinded: [---]*
Control: Other
Purpose: Health care system
Assignment: Other
Phase: N/A
Off-label Drug use: N/A

end of 1:1-Block design

start of 1:1-Block primary endpoint

Primary Outcome

Number of accepted applications of rehabilitation in Deutsche Rentenversicherung Mitteldeutschland for each general practitioner for the interval over 6 months before and 6 months after the medical education (intervention). The data is provided in strictly pseudonymous form by the Rentenversicherung Mitteldeutschland.

end of 1:1-Block primary endpoint

start of 1:1-Block secondary endpoint

Secondary Outcome

Change in the specific knowledge about Rehabilitation. This data will be obtained by questionnaires (modified BEvacomp + HILFE-II) immediately and 6 month after the medical education.

end of 1:1-Block secondary endpoint

start of 1:n-Block recruitment countries

Countries of Recruitment

DE: Germany

end of 1:n-Block recruitment countries

start of 1:n-Block recruitment locations

Locations of Recruitment

University Medical Center Sektion Allgemeinmedizin und Institut für Rehabilitation, Halle Saale

end of 1:n-Block recruitment locations

start of 1:1-Block recruitment

Recruitment

Planned/Actual: Actual
(Anticipated or Actual) Date of First Enrollment: 2015/07/31
Target Sample Size: 1262
Monocenter/Multicenter trial: Multicenter trial
National/International: National

end of 1:1-Block recruitment

start of 1:1-Block inclusion criteria

Inclusion Criteria

Gender: Both, male and female
Minimum Age: 29 Years
Maximum Age: 88 Years

end of 1:1-Block inclusion criteria

start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Family doctors in Saxony-Anhalt

end of 1:1-Block inclusion criteria add

start of 1:1-Block exclusion criteria

Exclusion Criteria

Refusion of participation in the trial and pure private doctors

end of 1:1-Block exclusion criteria

start of 1:n-Block addresses

Addresses

Primary Sponsor
start of 1:1-Block address primary-sponsor
- Medizinische Fakultät der Universität Halle
- Mr. Prof. Dr. Michael Gekle
- Magdeburger Str. 8
- 06112 Halle
- Germany
end of 1:1-Block address primary-sponsor

start of 1:1-Block address contact primary-sponsor
- Telephone: 0345 5571893
- Fax: 0345 5571493
- E-mail: dekan at medizin.uni-halle.de
- URL: http://www.medfak.uni-halle.de/
end of 1:1-Block address contact primary-sponsor
Collaborator, Other Address
start of 1:1-Block address other
- Deutsche Rentenversicherung Mitteldeutschland
- Mr. Dr. Wolfgang Kohl
- Georg-Schumann-Straße 146
- 04159 Leipzig
- Germany
end of 1:1-Block address other

start of 1:1-Block address contact other
- Telephone: 0341 550-55
- Fax: 0341 550-5900
- E-mail: service at drv-md.de
- URL: http://www.deutsche-rentenversicherung.de/Mitteldeutschland/de/Navigation/0_Home/home_node.html
end of 1:1-Block address contact other
Collaborator, Other Address
start of 1:1-Block address other
- Kassenärztliche Vereinigung Sachsen-Anhalt
- Mr. Dr. Burkhard John
- Doctor-Eisenbart-Ring 2
- 39120 Magdeburg
- Germany
end of 1:1-Block address other

start of 1:1-Block address contact other
- Telephone: 0391 6 27 60 00
- Fax: 0391 627 89 99
- E-mail: Burkhard.John at kvsa.de
- URL: http://www.kvsa.de/
end of 1:1-Block address contact other
Collaborator, Other Address
start of 1:1-Block address other
- Hausärzteverband Sachsen-Anhalt e.V.
- Mr. Diplommediziner Stefan Andrusch
- Margaretenstr. 2
- 39218 Schönebeck
- Germany
end of 1:1-Block address other

start of 1:1-Block address contact other
- Telephone: 03928 69170
- Fax: 03928 900555
- E-mail: info at hausaerzteverband-sachsen-anhalt.de
- URL: http://www.hausaerzteverband-sachsen-anhalt.de
end of 1:1-Block address contact other
Contact for Scientific Queries
start of 1:1-Block address scientific-contact
- Institut für RehabilitationMedizinische Fakultät der Universität Halle
- Mr. Prof. Dr. Wilfried Mau
- Magdeburger Str. 8
- 06112 Halle
- Germany
end of 1:1-Block address scientific-contact

start of 1:1-Block address contact scientific-contact
- Telephone: 0345 5574204
- Fax: 0345 5574206
- E-mail: wilfried.mau at medizin.uni-halle.de
- URL: http://www.medizin.uni-halle.de/index.php?id=647
end of 1:1-Block address contact scientific-contact
Contact for Public Queries
start of 1:1-Block address public-contact
- Sektion AllgemeinmedizinMedizinische Fakultät der Universität Halle
- Mr. Prof. Dr. Andreas Klement
- Magdeburger Str. 8
- 06112 Halle
- Germany
end of 1:1-Block address public-contact

start of 1:1-Block address contact public-contact
- Telephone: 0345 5575339
- Fax: 0345 5575340
- E-mail: andreas.klement at medizin.uni-halle.de
- URL: http://www.medizin.uni-halle.de/index.php?id=2130
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

Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
start of 1:1-Block address materialSupport
- Deutsche Rentenversicherung Mitteldeutschland
- Mr. Dr. Wolfgang Kohl
- Georg-Schumann-Straße 146
- 04159 Leipzig
- Germany
end of 1:1-Block address materialSupport

start of 1:1-Block address contact materialSupport
- Telephone: 0341 550-55
- Fax: 0341 550-5900
- E-mail: service at drv-md.de
- URL: http://www.deutsche-rentenversicherung.de/Mitteldeutschland/de/Navigation/0_Home/home_node.html
end of 1:1-Block address contact materialSupport

end of 1:n-Block material support

start of 1:1-Block state

Status

Recruitment Status: Recruiting complete, follow-up continuing
Study Closing (LPLV): [---]*

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.