Condition category
Musculoskeletal Diseases
Date applied
18/05/2005
Date assigned
24/05/2005
Last edited
07/01/2008
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Thomas Rosemann

ORCID ID

Contact details

Vosstrasse 2
Heidelberg
69115
Germany
+49 6221 565213
thomas_rosemann@med.uni-heidelberg.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

01GK0301

Study information

Scientific title

Acronym

PraxArth

Study hypothesis

A targeted medical education for GPs on arthritis has no effect on the quality of life of patients with degenerative joint diseases and their health care utilization.
Monitoring GPs’ prescriptions and advices for lifestyle changes by monthly telephone calls of practice assistants is not superior.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Multi-centre

Trial setting

GP practices

Trial type

Quality of life

Patient information sheet

Condition

Osteoarthritis

Intervention

1. Directed training of GPs and a monthly telephone follow up by practice nurses
2. Directed training of GPs only
3. Control: no intervention

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Quality of life assessed by the AIMS2-SF questionnaire, an internationally validated instrument for the assessment of quality of life among arthritis patients

Secondary outcome measures

Secondary outcomes include:
1. Health care utilization (referrals to orthopedists, imaging, inpatient care, physiotherapy)
2. Medication (evidence based use of NSAR, application of World Health Organisation [WHO]-recommendations)
3. Physical activity
4. Patient satisfaction (modified EUROPEP-questionnaire)
5. Potential confounders are being controlled (concurrent depression may influence the potential motivational change for more physical activity: PHQ-9)

Overall trial start date

01/06/2005

Overall trial end date

31/12/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adult patients, diagnosed with gonarthritis or coxarthritis according to the American College of Rheumatology (ACR) Citeria (identified by International Statistical Classification of Diseases and Related Health Problems - tenth revision [ICD-10] code in patient's file: M 16.0-16.9, M 17.0-17.5). Participating practices keep an alphabetic record of their patients. Patients from this list are contacted in consecutive order of appearance in the practice and informed about the option to participate in the study.
2. Written informed consent of the patient.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

75 GPs and 1125 patients

Participant exclusion criteria

1. Insufficient German language skills
2. Patients who contacted the practice for emergencies only or as a substitute practice

Recruitment start date

01/06/2005

Recruitment end date

31/12/2005

Locations

Countries of recruitment

Germany

Trial participating centre

Vosstrasse 2
Heidelberg
69115
Germany

Sponsor information

Organisation

Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung) (BMBF) (Germany)

Sponsor details

Hannoversche Strasse 28-30
Berlin
10115
Germany
+49 1888 57 0
bmbf@bmbf.bund.de

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

Federal Ministry of Education and Research (Germany)

Alternative name(s)

Federal Ministry of Education and Research, BMBF

Funding Body Type

government organisation

Funding Body Subtype

federal

Location

Germany

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16029495

Publication citations

  1. Rosemann T, Körner T, Wensing M, Gensichen J, Muth C, Joos S, Szecsenyi J, Rationale, design and conduct of a comprehensive evaluation of a primary care based intervention to improve the quality of life of osteoarthritis patients. The PraxArt-project: a cluster randomized controlled trial [ISRCTN87252339]., BMC Public Health, 2005, 5, 77, doi: 10.1186/1471-2458-5-77.

Additional files

Editorial Notes