None listed
Conditions
Brief summary
This study is designed to address the issue of smoking in Crohn's Disease patients. It has been well established that smoking has an negative impact on patients with IBD, particularly Crohn’s disease (CD). Smoking increases the risk of disease flares, Crohn's disease reoccurrence after surgery and most recently, has been demonstrated as a risk factor for Loss of response to IBD medications. Considering this, it is essential to ensure IBD patients quit smoking to improve their disease outcomes, improve their quality of life and ensure optimal use of medication. As most major IBD centres have access to IBD nursing services, whose role is largely to support patient education and managing helplines to prevent adverse outcomes. The IBD nurse has the most contact with IBD patients thus, the IBD nurse is well placed to assist smoking cessation interventions. The hypothesis of this study is that a nurse-led service that utilises motivational interviewing and nicotine replacement therapy will assist patients suffering with Crohn's disease to stop smoking.
Interventions
Participants randomised to the intervention arm of this pilot study will undergo a motivational interview at baseline, week 6 and at study completion (week 12). Motivational interviewing techniques employed will be based on the Royal Australian College of General Practitioners guidelines. The motivational interview will take approximatley 45 minutes to 1 hour and will be administered by an IBD Nurse. Participants will have follow up phone calls on a fortnightly basis until study completion. Thes
Participants randomised to the intervention arm of this pilot study will undergo a motivational interview at baseline, week 6 and at study completion (week 12). Motivational interviewing techniques employed will be based on the Royal Australian College of General Practitioners guidelines. The motivational interview will take approximatley 45 minutes to 1 hour and will be administered by an IBD Nurse. Participants will have follow up phone calls on a fortnightly basis until study completion. These follow-up phone calls will be utilised to monitor participant progress and adherence to the intervention. These participants will be prescribed nicotine replacement therapy by their treating Gastroenterologist based upon their results from the Fagerstrom assessment at the commencement of the study. Nicotine replacement therapy will include Nicotine 21mg/24hour patch, Nicotine 14mg/24hour patch and Nicotine 7mg/24hour patch. These patches will be administered topically and will be changed every 24hours. Participants will be provided with the correct patch strength based on the results of the Fagerstrom test.
Sponsors
Fiona Stanley Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 18 years of age or older 2. Diagnosis of Crohn’s Disease 3. Current smokers who are wanting to quit (a readiness to quit ladder rating of 6 or higher)
Exclusion criteria
1. Under 18 years of age. 2. No formal Crohn’s Disease diagnosis 3. Unwilling to quit (as measured on the readiness to quit ladder of 5 or less).
Outcome results
None listed