Educational material on cardiovascular disease in rheumtoid arthritis (RA)
| ISRCTN | ISRCTN51750274 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN51750274 |
| Protocol serial number | 4566 |
| Sponsor | Dudley Group of Hospitals NHS Foundation Trust (UK) |
| Funder | Arthritis Research Campaign (ARC) (UK) |
- 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
Scientific
Rheumatology Department
Russells Hall Hospital
Pensnett Road
Dudley
DY1 2HQ
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised interventional process of care trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
Knowledge of heart disease at 6 months |
| Key secondary outcome measure(s) |
Measured at baseline, 2 months and 6 months: |
| Completion date | 01/11/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Rheumatology Department
Dudley
DY1 2HQ
United Kingdom
DY1 2HQ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
