Randomised controlled trial: impact of a patient information leaflet on satisfaction with care, knowledge and QOL in irritable bowel disease
| ISRCTN | ISRCTN55878813 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN55878813 |
| Secondary identifying numbers | N0025172370 |
- Submission date
- 29/09/2006
- Registration date
- 29/09/2006
- Last edited
- 06/11/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr CKW Luces
Scientific
Scientific
AintreeTrust
University Hospital Aintree
Lower Lane
Liverpool
L9 7AL
United Kingdom
| Phone | +44 |
|---|
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Quality of life |
| Scientific title | |
| Study objectives | This study is designed to determine whether there is a benefit in terms of satisfaction with care, disease-specific knowledge and QOL for inflammatory bowel disease patients who receive education about their illness by means of an information leaflet compared to those who do not. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Digestive System: Irritable Bowel Disease (IBD) |
| Intervention | The first phase of project is distribution of leaflets to 20 volunteer patients and nursing staff and doctors. Comments will be invited on the sheets and returned to investigators. Eligible patients will be identified from out-patients and invited to participate, and if they fill out a questionnaire will be later interviewed. Within 2 weeks of baseline assessment patients will be randomised into two groups with Crohn's Disease and Ulcerative Colitis. A further questionnaire will be sent via post at 3 and 12 months after recruitment followed by a further interview at 6-12 months at clinic appointment. |
| Intervention type | Other |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/12/2005 |
| Completion date | 01/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target number of participants | 300 IBD patients |
| Key inclusion criteria | 300 IBD patients |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/12/2005 |
| Date of final enrolment | 01/12/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
AintreeTrust
Liverpool
L9 7AL
United Kingdom
L9 7AL
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government
Government
The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Aintree Hospitals NHS Trust (UK)
No information available
NHS R&D Support Funding (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 |
