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 |
| Secondary identifying numbers | 01GK0301 |
- 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
Scientific
Vosstrasse 2
Heidelberg
69115
Germany
| Phone | +49 6221 565213 |
|---|---|
| thomas_rosemann@med.uni-heidelberg.de |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Multi-centre |
| Study setting(s) | GP practice |
| Study type | Quality of life |
| 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 | 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 study start date | 01/06/2005 |
| Completion date | 31/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 75 GPs and 1125 patients |
| 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
69115
Germany
Sponsor information
Federal Ministry of Education and Research (Bundesministerium Für Bildung und Forschung) (BMBF) (Germany)
Government
Government
Hannoversche Strasse 28-30
Berlin
10115
Germany
| Phone | +49 1888 57 0 |
|---|---|
| bmbf@bmbf.bund.de | |
"ROR" |
https://ror.org/04pz7b180 |
Funders
Funder type
Government
Federal Ministry of Education and Research (Germany)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Federal Ministry of Education and Research, BMBF
- Location
- Germany
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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.
