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

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
Email g.rait@pcps.ucl.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study acronymDASH
Study objectivesStudies 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) studiedOsteoarthritis
InterventionCurrent 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 typeOther
Primary outcome measure1. 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 measuresCurrent 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 date01/12/2000
Completion date31/03/2004

Eligibility

Participant type(s)Patient
Age groupSenior
SexBoth
Target number of participants812
Key inclusion criteriaCurrent 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 criteriaCurrent 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 enrolment01/12/2000
Date of final enrolment31/03/2004

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

MRC GPRF & Department of Primary Care & Population Sciences
London
NW3 2PF
United Kingdom

Sponsor information

NHS R&D Regional Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email 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
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 shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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