Condition category
Musculoskeletal Diseases
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
22/07/2013
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 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 measures

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

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

http://www.doh.gov.uk

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

Results - basic reporting

Publication summary

2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18815153

Publication citations

  1. 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.

Additional files

Editorial Notes