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Randomised controlled trial (RCT) of the use of an arthritis self management programme in primary care
ISRCTN ISRCTN79115352
DOI 10.1186/ISRCTN79115352
ClinicalTrials.gov identifier
EudraCT number
Public title Randomised controlled trial (RCT) of the use of an arthritis self management programme in primary care
Scientific title
Acronym DASH
Serial number at source RDC01907
Study hypothesis 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.
Lay summary Not provided at time of registration
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Osteoarthritis
Participants - 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).
Participants - 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.
Anticipated start date 01/12/2000
Anticipated end date 31/03/2004
Status of trial Completed
Patient information material
Target number of participants 812
Interventions 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
Primary outcome measure(s) 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 measure(s) 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
Sources of funding Medical Research Council (MRC) (UK)
Trial website
Publications 1. 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/17040926
2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19773329
Contact name Dr  Greta  Rait
  Address MRC GPRF & Department of Primary Care & Population Sciences
Royal Free and University College Medical School
Hampstead Campus
Rowland Hill Street
  City/town London
  Zip/Postcode NW3 2PF
  Country United Kingdom
  Tel +44 (0)20 7472 6878
  Email g.rait@pcps.ucl.ac.uk
Sponsor NHS R&D Regional Programme Register - Department of Health (UK)
  Address The Department of Health
Richmond House
79 Whitehall
  City/town London
  Zip/Postcode SW1A 2NL
  Country United Kingdom
  Tel +44 (0)20 7307 2622
  Fax +44 (0)20 7307 2623
  Email dhmail@doh.gsi.org.uk
  Sponsor website: http://www.doh.gov.uk
Date applied 23/01/2004
Last edited 01/03/2013
Date ISRCTN assigned 23/01/2004
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