Multidisciplinary versus traditional outpatient management of osteoarthritis: a randomised, controlled trial in Norway
| ISRCTN | ISRCTN25778426 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN25778426 |
| Secondary identifying numbers | N/A |
- Submission date
- 04/10/2006
- Registration date
- 15/11/2006
- Last edited
- 28/08/2012
- 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 Margreth Grotle
Scientific
Scientific
National Resource Center for Rehabilitation in Rheumatology
Diakonhjemmet Hospital
P.O.Box 23
Vinderen
Oslo
0319
Norway
| Phone | +47 22 45 48 47 |
|---|---|
| margreth.grotle@medisin.uio.no |
Study information
| Study design | Randomised single-blind controlled study with four arms and one year of follow-up |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | OsteoArthritis (OA) is a term used to describe both the degenerative disease of synovial joints with its accompanying radiographic signs, and the clinical syndrome of pain, stiffness and restricted movement of the joints. OA is the commonest cause of chronic pain in older people, and the most frequent reason for activity limitations in this age-group. OA of the knee and hip have the greatest impact on individuals, but OA in hand is also commonly affected. With an increasing proportion of older people in the population, OA assumes a growing public health problem. The aims of this trial are: 1. Patients with OsteoArthritis (OA) in hip, knee, hand and/or generalised OA who enter a multidisciplinary outpatient clinic, providing a brief group education intervention and individual consultations according to their needs, will be more satisfied with the health service and their health status than patients who receive individual consultation(s) in a traditional individual outpatient clinic. 2. We expect no clinically significant difference in pain and disability between patients who enter a multidisciplinary outpatient clinic and patients who enter a traditional individual outpatient clinic. 3. Patients with OA in hip, knee, hand and/or generalised OA who receive a telephone follow-up interview will be more satisfied with the health service and their health status than patients who receive follow-up 'as usual' (patients contact the clinic when necessary). 4. Patients with OA in hip, knee, hand and/or generalised OA who receive both the multidisciplinary outpatient clinic intervention and a telephone follow-up interview will have a significant effect on patient satisfaction, pain and disability when compared to patients who enter a traditional individual outpatient clinic with follow-up 'as usual'. 5. On the longer term, a multidisciplinary outpatient clinic, providing a brief group education intervention and individual consultations according to the patients' individual needs will be more cost-efficient than a traditional individual outpatient clinic for patients with OA in hip, knee, hand and/or generalised OA. 6. On the longer term, a multidisciplinary outpatient clinic and a telephone follow-up interview will be more cost-efficient than a traditional individual outpatient clinic with follow-up 'as usual' for patients with OA in hip, knee, hand and/or generalised OA. |
| Ethics approval(s) | The Ethics Committee for Medical Research, Oslo, Norway, approved on the 7th of March 2006 (ref. no: 156-06073 1.2006.598). |
| Health condition(s) or problem(s) studied | OsteoArthritis (OA) |
| Intervention | Both interventions are carried out in an outpatient clinic for rheumatology diseases: The first intervention is a traditional individual outpatient clinic, in which the patients are referred to a rheumatologist. If they need further investigation, the patients may be referred to other specialists such as physiotherapist, occupational therapist, etc..., The second intervention is a new multidisciplinary intervention, in which the referred patients first receive a four hour group education on OA ("OA school") and then receive individual consultations according to their needs: that is six specialist groups are available for consultation after the education part: rheumatologist, orthopedian specialist, physiotherapist, occupational therapist, pharmacist, and dietician. In the second part of the trial, after first follow-up, one group of patients receive a brief telephone follow-up interview of approximately ten minutes. The other group of patients is followed as usual, that is the patients may contact the clinic if they need. |
| Intervention type | Other |
| Primary outcome measure | 1. Patient satisfaction with the health service and their health status 2. Cost-efficiency |
| Secondary outcome measures | The secondary outcome(s) are pain and disability assessed by standardised disease-specific and generic outcome measures. |
| Overall study start date | 01/08/2006 |
| Completion date | 01/08/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 400 |
| Key inclusion criteria | 1. Men and women between 40 and 80 years old 2. OA in hip, knee, hand and/or generalised OA 3. Referred to a specialist clinic at a hospital in Norway |
| Key exclusion criteria | 1. Cognitive impairments 2. Recent trauma in the extremities 3. Recent surgery, other specified diseases such as rheumatoid arthritis, cancer etc.., 4. Difficulties understanding Norwegian (both verbal and written language) |
| Date of first enrolment | 01/08/2006 |
| Date of final enrolment | 01/08/2009 |
Locations
Countries of recruitment
- Norway
Study participating centre
National Resource Center for Rehabilitation in Rheumatology
Oslo
0319
Norway
0319
Norway
Sponsor information
National Resource Center for Rehabilitation in Rheumatology (Norway)
Hospital/treatment centre
Hospital/treatment centre
Diakonhjemmet Hospital
P.O.Box 23
Vinderen
Oslo
N-0319
Norway
"ROR" |
https://ror.org/02jvh3a15 |
|---|
Funders
Funder type
Hospital/treatment centre
National Resource Center for Rehabilitation in Rheumatology, Diakonhjemmet Hospital (Norway)
No information available
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? |
|---|---|---|---|---|---|
| Protocol article | protocol | 01/11/2010 | Yes | No | |
| Results article | results | 01/01/2013 | Yes | No |
