Condition category
Musculoskeletal Diseases
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
01/03/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Greta Rait

ORCID ID

Contact details

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
+44 (0)20 7472 6878
g.rait@pcps.ucl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RDC01907

Study information

Scientific title

Acronym

DASH

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.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/12/2000

Overall trial end date

31/03/2004

Reason abandoned

Eligibility

Participant 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).

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

812

Participant 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.

Recruitment start date

01/12/2000

Recruitment end date

31/03/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Sponsor information

Organisation

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

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2006 results in http://www.ncbi.nlm.nih.gov/pubmed/17040926
2. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19773329

Publication citations

  1. Results

    Buszewicz M, Rait G, Griffin M, Nazareth I, Patel A, Atkinson A, Barlow J, Haines A, Self management of arthritis in primary care: randomised controlled trial., BMJ, 2006, 333, 7574, 879, doi: 10.1136/bmj.38965.375718.80.

  2. Results

    Patel A, Buszewicz M, Beecham J, Griffin M, Rait G, Nazareth I, Atkinson A, Barlow J, Haines A, Economic evaluation of arthritis self management in primary care., BMJ, 2009, 339, b3532.

Additional files

Editorial Notes