Randomised controlled trial (RCT) of the use of an arthritis self management programme in primary care
- Conditions
- OsteoarthritisMusculoskeletal Diseases1. Coxarthrosis [arthrosis of hip]2. Gonarthrosis [arthrosis of knee]
- Registration Number
- ISRCTN79115352
- Lead Sponsor
- HS R&D Regional Programme Register - Department of Health (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 812
Current inclusion criteria as of 01/03/2013:
1. Age 45 years or above
2. Diagnosis of osteoarthritis from General Practitioner (GP) affecting 'central' joints, i.e. neck, shoulders, hips and knees but not lumbar spine alone
3. Duration of problem of at least three months and at least two visits to the GP within the past year because of related problems (eg pain, functional disability)
4. Screening question to patient to establish whether significant pain and/or functional disability associated with the condition during the past month
Previous inclusion criteria until 01/03/2013:
1. Patients aged 50 years or above, with osteoarthritis affecting the knee or hip for at least a year, will be recruited. The aim is to recruit 40 general practices which will be matched with local Arthritis Care groups, and to recruit 30 patients per practice (15 in the intervention arm and 15 controls).
Current exclusion criteria as of 01/03/2013:
1. Too immobile to be able to get to the surgery for the group.
2. Understanding of English insufficient to be able to participate in the group.
3. Referred for consideration of surgery for arthritis.
4. Patients with lumbar back pain alone (this group may form the basis of subsequent trial)
5. Patients with neurological signs e.g. related to cervical disorders
6. Known cognitive impairment or inability to complete questionnaires
Previous exclusion criteria until 01/03/2013:
1. Immobile
2. Understanding of English is insufficient to participate
3. Referred for surgery for their arthritis
4. Associated neurological signs or known cognitive impairment making patients unable to complete questionnaires.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. The majority of outcome measures will be assessed by postal questionnaires sent to participants at baseline, 4 and 12 months. These will include: <br>1.1. quality of life<br>1.2. functional disability<br>1.3. pain<br>1.4. anxiety<br>1.5. depression<br>1.6. perceived self-efficacy mechanisms<br>1.7. information required for an economic analysis. <br>2. A sample of patients in the intervention group will be invited to be interviewed in depth in their homes at three points in time in order to gain more information about participants' perceptions and attitudes towards the intervention. <br>3. SF 36 to assess Quality of Life.
- Secondary Outcome Measures
Name Time Method Current secondary outcome measures as of 01/03/2013:<br>1. Functional Disability, measured using the WOMAC osteoarthritis index <br>2. Control over symptoms measured using the Arthritis Self-Efficacy Scale (ASE) <br>3. Anxiety and Depression measured using the Hospital Anxiety & Depression Scale (HADS) <br>4. Cost-effectiveness measured using the Client Service Receipt Inventory (CSRI) <br>5. Euroqol (EQ-5D) health status classification system<br><br>Previous secondary outcome measures until 01/03/2013:<br>1. Womac osteoarthritis index <br>2. Arthritis Self-Efficacy Scale (ASE) <br>3. Hospital Anxiety & Depression Scale (HADS) <br>4. Client Service Receipt Inventory (CSRI) <br>5. Euroqol (EQ-5D) health status classification system