|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ISRCTN |
|
Last refreshed on:
|
13 January 2015 |
|
Main ID: |
ISRCTN21633644 |
|
Date of registration:
|
26/04/2006 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Can we prevent Crohn's disease: a National study
|
|
Scientific title:
|
Assessing and reducing risk of Crohn's disease in smokers |
|
Date of first enrolment:
|
01/01/2006 |
|
Target sample size:
|
500 |
|
Recruitment status: |
Completed |
|
URL:
|
http://isrctn.com/ISRCTN21633644 |
|
Study type:
|
Interventional |
|
Study design:
|
Parallel group randomised controlled trial (Treatment)
|
|
Phase:
|
|
|
|
Countries of recruitment
|
|
United Kingdom
| | | | | | | |
|
Contacts
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
|
|
Name:
|
Theresa M
Marteau |
|
Address:
|
Health Psychology Section
Department of Psychology (at Guy's)
5th Floor Thomas Guy House
Guy's Campus
SE1 9RT
London
United Kingdom |
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria: 1. First degree relatives of patients with Crohn's disease
2. Aged over 18 years
3. Living in the British Isles
4. Without a diagnosis of Crohn's disease or ulcerative colitis
5. Male or female
6. Smoke 5 or more cigarettes daily
7. Able to give informed consent to participate
8. Able to complete, either alone or with assistance, the study questionnaires
Exclusion criteria: Those not meeting the inclusion criteria
Age minimum:
Age maximum:
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
Crohn's disease
Digestive System
Crohn's disease
|
|
Intervention(s)
|
|
The trial objective is to describe the impact upon motivation to stop smoking of using genotype to assess risk of developing Crohn's disease. We will compare the impact of risk assessment based on family history and DNA testing versus assessment based on family history alone.
|
|
Primary Outcome(s)
|
Current primary outcome as of 28/04/2008:
Stopping smoking for 24 hours or longer in the six months following provision of risk information.
Previous primary outcome:
The proportion of participants in each group engaging in 1 or more quit-related behaviours, measured 6 months after participants are presented with their personalised risk information.
|
|
Secondary Outcome(s)
|
|
The proportion of participants in each group who make smoking quit attempts of 6 or more days duration. This will be validated using questionnaires and biochemical indices.
|
|
Source(s) of Monetary Support
|
|
Medical Research Council - Health Services and Public Health Research Board (HSPHRB; ref G0500274) (UK)
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|