Condition category
Musculoskeletal Diseases
Date applied
29/04/2010
Date assigned
29/04/2010
Last edited
29/07/2013
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 Holly John

ORCID ID

Contact details

Rheumatology Department
Russells Hall Hospital
Pensnett Road
Dudley
DY1 2HQ
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

4566

Study information

Scientific title

Development and evaluation of educational material to address the cardiovascular aspects of rheumatoid disease

Acronym

Study hypothesis

This study compares a cognitive behavioural educational course addressing cardiovascular risk factors in patients with rheumatoid arthrits against a standard education leaflet using knowledge of heart disease, lifestyle behaviours and clinical results as outcome measures.

Ethics approval

Dudley Local Research Ethics Committee approved on the 12th December 2006 (ref: 06/Q2702/81)

Study design

Randomised interventional process of care trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Cardiovascular; Subtopic: Cardiovascular (all Subtopics); Disease: Cardiovascular

Intervention

The intervention is an 8-week cognitive behavioural education course about cardiovascular disease in rheumatoid arthritis which is compared against a leaflet about CVD in RA. Follow up for both groups is 6 months in total.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Knowledge of heart disease at 6 months

Secondary outcome measures

Measured at baseline, 2 months and 6 months:
1. Self efficacy questionnaires for stopping smoking
2. Exercise
3. Healthy eating and achieving a normal weight
4. Smoking status
5. Diet diary
6. International Physical Activity Questionnaire
7. Weight
8. Blood pressure
9. Lipid profile
10. Disease activity score in 28 joints
11. EuroQol

Overall trial start date

04/01/2007

Overall trial end date

01/11/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Diagnosis of rheumatoid arthritis
2. Aged over 18 years, either sex
3. Any ethnicity
4. The ability to read, understand and write English

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 180

Participant exclusion criteria

1. Severe mental illness
2. Terminal physical illness

Recruitment start date

04/01/2007

Recruitment end date

01/11/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Rheumatology Department
Dudley
DY1 2HQ
United Kingdom

Sponsor information

Organisation

Dudley Group of Hospitals NHS Foundation Trust (UK)

Sponsor details

Department of Rheumatology
Dudley
DY1 2HQ
United Kingdom

Sponsor type

Government

Website

http://www.dgoh.nhs.uk/home/

Funders

Funder type

Charity

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

2013 results in http://www.ncbi.nlm.nih.gov/pubmed/22942402

Publication citations

  1. Results

    John H, Hale ED, Treharne GJ, Kitas GD, Carroll D, A randomized controlled trial of a cognitive behavioural patient education intervention vs a traditional information leaflet to address the cardiovascular aspects of rheumatoid disease., Rheumatology (Oxford), 2013, 52, 1, 81-90, doi: 10.1093/rheumatology/kes237.

Additional files

Editorial Notes