The PraxArth-Study: Improving quality of life of osteoarthritis patients by directed training of general practictioners (GPs) and a telephone follow up through practice nurses

ISRCTN	ISRCTN87252339
DOI	https://doi.org/10.1186/ISRCTN87252339
Protocol serial number	01GK0301
Sponsor	Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung) (BMBF) (Germany)
Funder	Federal Ministry of Education and Research (Germany)

Submission date: 18/05/2005
Registration date: 24/05/2005
Last edited: 06/11/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Thomas Rosemann
Scientific

Vosstrasse 2
Heidelberg
69115
Germany

Phone	+49 6221 565213
Email	thomas_rosemann@med.uni-heidelberg.de

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Multi-centre
Scientific title	The PraxArth-Study: Improving quality of life of osteoarthritis patients by directed training of general practictioners (GPs) and a telephone follow up through practice nurses
Study acronym	PraxArth
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Quality of life assessed by the AIMS2-SF questionnaire, an internationally validated instrument for the assessment of quality of life among arthritis patients
Key secondary outcome measure(s)	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)
Completion date	31/12/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	1125
Key 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.
Key exclusion criteria	1. Insufficient German language skills 2. Patients who contacted the practice for emergencies only or as a substitute practice
Date of first enrolment	01/06/2005
Date of final enrolment	31/12/2005

Locations

Countries of recruitment

Germany

Study participating centre

Vosstrasse 2

Heidelberg
69115
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Abstract results		19/07/2005		No	No

Editorial Notes

06/11/2019: Internal review.