Randomised controlled trial (RCT) of the use of an arthritis self management programme in primary care
| ISRCTN | ISRCTN79115352 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN79115352 |
| Secondary identifying numbers | RDC01907 |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 01/03/2013
- 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 Greta Rait
Scientific
Scientific
MRC GPRF & Department of Primary Care & Population Sciences
Royal Free and University College Medical School
Hampstead Campus
Rowland Hill Street
London
NW3 2PF
United Kingdom
| Phone | +44 (0)20 7472 6878 |
|---|---|
| g.rait@pcps.ucl.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | DASH |
| Study objectives | Studies have shown that arthritis self-management programmes (ASMPs) can have a beneficial effect on a variety of outcomes, including pain, depression, and participants' self-perception about their capacity to manage their own condition. There are no controlled trials of such an intervention in primary care. This is the first trial in the General Practice Research Framework (GPRF) run in collaboration with the voluntary sector. Added 01/03/2013: The trial aims to find out: 1. Whether participation in an arthritis self-management programme plus provision of a specially designed education booklet improves the quality of life and other psycho-social outcomes of general practice patients with osteo-arthritis of the knees and/or hips when compared with provision of an education booklet alone. 2. In addition, whether the arthritis self-management programme is a cost-effective intervention for the target population. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Osteoarthritis |
| Intervention | Current interventions as of 01/03/2013: 1. Group A will receive a leaflet especially designed for the study incorporating information about arthritis and its management. 2. Group B will receive the same leaflet, but also be invited to participate in the intervention involving the Arthritis Self-Management Plan. This group intervention consists of six weekly sessions of 2.5 h each in groups of 12-15 members. The intervention is delivered by a lay member of Arthritis Care, who themselves will have arthritis, at a 'neutral' venue close to the surgery premises. Areas covered within the six sessions include: basic information about arthritis and its treatment, principles of pain management, the benefits of exercise, principles and practice of problem solving and goal setting, strategies for dealing with depression and anger and communication skills to be used with family and health professionals. Previous interventions until 01/03/2013: 1. Education in arthritis self-management 2. Standard care |
| Intervention type | Other |
| Primary outcome measure | 1. The majority of outcome measures will be assessed by postal questionnaires sent to participants at baseline, 4 and 12 months. These will include: 1.1. quality of life 1.2. functional disability 1.3. pain 1.4. anxiety 1.5. depression 1.6. perceived self-efficacy mechanisms 1.7. information required for an economic analysis. 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. 3. SF 36 to assess Quality of Life. |
| Secondary outcome measures | Current secondary outcome measures as of 01/03/2013: 1. Functional Disability, measured using the WOMAC osteoarthritis index 2. Control over symptoms measured using the Arthritis Self-Efficacy Scale (ASE) 3. Anxiety and Depression measured using the Hospital Anxiety & Depression Scale (HADS) 4. Cost-effectiveness measured using the Client Service Receipt Inventory (CSRI) 5. Euroqol (EQ-5D) health status classification system Previous secondary outcome measures until 01/03/2013: 1. Womac osteoarthritis index 2. Arthritis Self-Efficacy Scale (ASE) 3. Hospital Anxiety & Depression Scale (HADS) 4. Client Service Receipt Inventory (CSRI) 5. Euroqol (EQ-5D) health status classification system |
| Overall study start date | 01/12/2000 |
| Completion date | 31/03/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 812 |
| Key inclusion criteria | 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). |
| Key exclusion criteria | 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. |
| Date of first enrolment | 01/12/2000 |
| Date of final enrolment | 31/03/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
MRC GPRF & Department of Primary Care & Population Sciences
London
NW3 2PF
United Kingdom
NW3 2PF
United Kingdom
Sponsor information
NHS R&D Regional Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.doh.gov.uk |
Funders
Funder type
Research council
Medical Research Council (MRC) (UK)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
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? |
|---|---|---|---|---|---|
| Results article | results | 28/10/2006 | Yes | No | |
| Results article | results | 22/09/2009 | Yes | No |
