Educational material on cardiovascular disease in rheumtoid arthritis (RA)

ISRCTN	ISRCTN51750274
DOI	https://doi.org/10.1186/ISRCTN51750274
Secondary identifying numbers	4566

Submission date: 29/04/2010
Registration date: 29/04/2010
Last edited: 29/07/2013

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 Holly John
Scientific

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

Study information

Study design	Randomised interventional process of care trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Diagnostic
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Development and evaluation of educational material to address the cardiovascular aspects of rheumatoid disease
Study objectives	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(s)	Dudley Local Research Ethics Committee approved on the 12th December 2006 (ref: 06/Q2702/81)
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	04/01/2007
Completion date	01/11/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Planned Sample Size: 180
Key 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
Key exclusion criteria	1. Severe mental illness 2. Terminal physical illness
Date of first enrolment	04/01/2007
Date of final enrolment	01/11/2009

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Rheumatology Department

Dudley
DY1 2HQ
United Kingdom

Sponsor information

Dudley Group of Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre

Department of Rheumatology
Dudley
DY1 2HQ
England
United Kingdom

Website	http://www.dgoh.nhs.uk/home/
"ROR"	https://ror.org/014hmqv77

Funders

Funder type

Charity

Arthritis Research Campaign (ARC) (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2013		Yes	No