Contact information
Type
Scientific
Primary contact
Dr A Hammond
ORCID ID
Contact details
Southern Derbyshire Acute Hosptials NHS Trust
Department of Rheumatology
Derbyshire Royal Infirmary
London Road
Derby
DE1 2QY
United Kingdom
+44 (0)1332 347141 ext. 2418
alison.hammond@sdah-tr.trent.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0077102835; H0643
Study information
Scientific title
Acronym
Study hypothesis
Null hypothesis: there is no significant difference in adherence with health behaviours or health status between people with arthritis attending a standard arthritis education programme and an education programme incorporating psycho-educational approaches.
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
Other
Trial type
Quality of life
Patient information sheet
Condition
Rheumatoid, inflammatory and psoriatic arthritis
Intervention
Participants randomly allocated to:
1. Standard Arthritis Education Programme (AEP): 5 x 2 hour weekly programme of education and practical advice delivered by the rheumatology team. Education based on standard practice, e.g., information about rheumatoid arthritis, drugs, exercise, joint protection, relaxation, pain management, benefits, diet.
2. Educational-behavioural programme: two modules of 4 x 2 hour weekly meetings plus a booster meeting:
Module 1: Joint Protection and Fatigue Management Specific training on joint protection (approx. 5 hour practical)
Module 2: Exercise, Pain and Stress Management
Booster meeting (includes drug therapy and test information)
Supported by information pack and patient workbook, goal setting, home programme.
Joint Sponsor Details:
Arthritis Research Campaign (ARC) (UK)
Copeman House
St Mary's Court
St Mary's Gate
Chesterfield, Derbyshire
S41 7TD
United Kingdom
Email: info@arc.org.uk
Website: http://www.arc.org.uk
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
1. Measures of adherence with self-management strategies
2. Functional, psychological and health status
3. Demographic and health care utilisation information
Outcomes will be evaluated using a self-report questionnaire mailed out before and at 6 and 12 months after education.
Secondary outcome measures
No secondary outcome measures
Overall trial start date
01/07/2001
Overall trial end date
30/07/2004
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. People with inflammatory arthritis attending the rheumatology department at DRI (i.e., rheumatoid arthritis, inflammatory arthropathy, psoriatic arthritis, seropositive or seronegative arthritis), diagnosed by a Consultant Rheumatologist
2. Aged over 18 years
3. Able to read English
4. Willing and able to attend an Arthritis Education Programme (AEP)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
150
Participant exclusion criteria
Severe disease/functional problems
Recruitment start date
01/07/2001
Recruitment end date
30/07/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Southern Derbyshire Acute Hosptials NHS Trust
Derby
DE1 2QY
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Southern Derbyshire Acute Hospitals NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Arthritis Research Campaign (ARC) (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
Basic results (scientific)
Publication list
2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18815153
Publication citations
-
Results
Hammond A, Bryan J, Hardy A, Effects of a modular behavioural arthritis education programme: a pragmatic parallel-group randomized controlled trial., Rheumatology (Oxford), 2008, 47, 11, 1712-1718, doi: 10.1093/rheumatology/ken380.