Contact information
Type
Scientific
Contact name
Dr Margreth Grotle
ORCID ID
Contact details
National Resource Center for Rehabilitation in Rheumatology
Diakonhjemmet Hospital
P.O.Box 23
Vinderen
Oslo
0319
Norway
+47 22 45 48 47
margreth.grotle@medisin.uio.no
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
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).
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
Patient information sheet
Condition
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
Overall study end date
01/08/2009
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type(s)
Patient
Age group
Adult
Sex
Both
Target number of participants
400
Participant 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)
Recruitment start date
01/08/2006
Recruitment end date
01/08/2009
Locations
Countries of recruitment
Norway
Study participating centre
National Resource Center for Rehabilitation in Rheumatology
Oslo
0319
Norway
Sponsor information
Organisation
National Resource Center for Rehabilitation in Rheumatology (Norway)
Sponsor details
Diakonhjemmet Hospital
P.O.Box 23
Vinderen
Oslo
N-0319
Norway
Sponsor type
Hospital/treatment centre
Website
ROR
Funders
Funder type
Hospital/treatment centre
Funder name
National Resource Center for Rehabilitation in Rheumatology, Diakonhjemmet Hospital (Norway)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
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 |