ISRCTN ISRCTN11478835
DOI https://doi.org/10.1186/ISRCTN11478835
Protocol serial number N0077102835; H0643
Sponsor Department of Health (UK)
Funders Southern Derbyshire Acute Hospitals NHS Trust (UK), Arthritis Research Campaign (ARC) (UK)
Submission date
12/09/2003
Registration date
12/09/2003
Last edited
22/07/2013
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 A Hammond
Scientific

Southern Derbyshire Acute Hosptials NHS Trust
Department of Rheumatology
Derbyshire Royal Infirmary
London Road
Derby
DE1 2QY
United Kingdom

Phone +44 (0)1332 347141 ext. 2418
Email alison.hammond@sdah-tr.trent.nhs.uk

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Scientific title
Study objectivesNull 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedRheumatoid, inflammatory and psoriatic arthritis
InterventionParticipants 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 typeOther
Primary outcome measure(s)

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.

Key secondary outcome measure(s)

No secondary outcome measures

Completion date30/07/2004

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexAll
Target sample size at registration150
Key inclusion criteria1. 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)
Key exclusion criteriaSevere disease/functional problems
Date of first enrolment01/07/2001
Date of final enrolment30/07/2004

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Southern Derbyshire Acute Hosptials NHS Trust
Derby
DE1 2QY
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/11/2008 Yes No