|
ISRCTN
|
ISRCTN74878628
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Randomised controlled trial of the use of an arthritis self-management programme in primary care
|
|
Scientific title
|
|
|
Acronym
|
DASH
|
|
Serial number at source
|
G9900306
|
|
Study hypothesis
|
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
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Arthritis
|
|
Participants - inclusion criteria
|
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
|
|
Participants - exclusion criteria
|
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
|
|
Anticipated start date
|
01/06/2000
|
|
Anticipated end date
|
30/06/2004
|
|
Status of trial
|
Completed |
|
Patient information material
|
|
|
Target number of participants
|
1000
|
|
Interventions
|
Participants who satisfy the inclusion criteria and consent to the trial will be randomised to one of two groups.
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.
|
|
Primary outcome measure(s)
|
Quality of Life measured by SF 36
|
|
Secondary outcome measure(s)
|
1. Functional Disability, measured using the WOMAC
2. Control over symptoms measured using the Arthritis Self-Efficacy Scale
3. Anxiety and Depression measured using the HADS and Cost-effectiveness measured using the CSRI
|
|
Sources of funding
|
Medical Research Council (MRC) (UK)
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Dr
Marta
Buszewicz
|
|
Address
|
Department of Primary Care and Population Sciences
Archway Resource Centre
2nd Floor Holborn Union Building
Highgate Hill
|
|
City/town
|
London
|
|
Zip/Postcode
|
N19 3UA
|
|
Country
|
United Kingdom
|
|
Email
|
|
|
Sponsor
|
Medical Research Council (MRC) (UK)
|
|
Address
|
20 Park Crescent
|
|
City/town
|
London
|
|
Zip/Postcode
|
W1B 1AL
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)20 7636 5422
|
|
Fax
|
+44 (0)20 7436 6179
|
|
Email
|
clinical.trial@headoffice.mrc.ac.uk
|
|
Sponsor website:
|
http://www.mrc.ac.uk
|
|
Date applied
|
23/10/2000
|
|
Last edited
|
03/08/2009
|
|
Date ISRCTN assigned
|
23/10/2000
|
