Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000679987
Ethics application status
Approved
Date submitted
5/05/2020
Date registered
15/06/2020
Date last updated
17/09/2021
Date data sharing statement initially provided
15/06/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Nurse-led stop smoking service versus standard doctor counselling for Inflammatory Bowel Disease (IBD) patients.
Scientific title
Nurse-led smoking cessation service utilising motivational interviewing and nicotine replacement therapy (NRT) versus standard of care counselling in IBD patients: A pilot study
Secondary ID [1] 301149 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease 317266 0
Smoking 317534 0
Condition category
Condition code
Oral and Gastrointestinal 315396 315396 0 0
Inflammatory bowel disease
Mental Health 315624 315624 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 317452 0
Lifestyle
Intervention code [2] 317453 0
Treatment: Other
Comparator / control treatment
Standard physician counselling - Standard Physician Counselling involves a discussion with the patient on impacts of smoking in inflammatory bowel disease. This traditionally is conducted over 5 to 10 minutes and is imbedded within patient consultation.
No NRT as currently, this is not standard practice amongst Gastroenterolgists working within IBD clinics.
Control group
Active

Outcomes
Primary outcome [1] 323641 0
Proportion of participants with confirmed cessation of smoking at week 12 as measured on the Readiness to Quit Ladder. Cessation of smoking will be defined as 'no cigarettes within the previous 7 days
Timepoint [1] 323641 0
Week 12
Secondary outcome [1] 382463 0
Change in smoking at week 12 as reported by patient confirmed on the Readiness to Quit Ladder, using the last 7 days as the measure.
Timepoint [1] 382463 0
Week 12
Secondary outcome [2] 382464 0
Change in C-Reactive Protein assessed by serum analysis.
Timepoint [2] 382464 0
Week 12
Secondary outcome [3] 382465 0
Change in Faecal Calprotectin assessed by stool sample.
Timepoint [3] 382465 0
Week 12
Secondary outcome [4] 382466 0
Change in CDAI score
Timepoint [4] 382466 0
Week 12
Secondary outcome [5] 382467 0
Change in patient quality of life as measured on the SIBDQ
Timepoint [5] 382467 0
Week 12
Secondary outcome [6] 383803 0
Change in patient quality of life as measured on the SF-36
Timepoint [6] 383803 0
Week 12
Secondary outcome [7] 383804 0
Rate of Adverse Events meausered by consultation with IBD nurse and if required, physical assessment by Gastroenterologist
Timepoint [7] 383804 0
Week 12

Eligibility
Key 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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be completed with an automated random allocation generation system. This allocation will occur after a participant has signed the informed consent form and has qualified for the study. The investigators conducting the randomisation will be have the allocation concealed until the patient is randomised.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
This is a pilot study and as such is not powered to show statistical significance. If a positive signal is received then this study will be the catalyst for a larger randomised control trial which will be powered to show statistical significance.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/08/2021
Actual
Date of last participant enrolment
Anticipated
31/08/2021
Actual
Date of last data collection
Anticipated
1/10/2021
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 16588 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 30177 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 305593 0
Commercial sector/Industry
Name [1] 305593 0
Janssen-Cilag PTY LTD
Country [1] 305593 0
Australia
Primary sponsor type
Hospital
Name
Fiona Stanley Hospital
Address
11 Robin Warren Dr
MURDOCH WA 6150
Country
Australia
Secondary sponsor category [1] 306006 0
None
Name [1] 306006 0
Address [1] 306006 0
Country [1] 306006 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305891 0
South Metropolitan Health Service Human Research Ethics Committee
Ethics committee address [1] 305891 0
Fiona Stanley Hospital
Education Building
Barry Marshall Parade
MURDOCH WA 6150
Ethics committee country [1] 305891 0
Australia
Date submitted for ethics approval [1] 305891 0
30/04/2020
Approval date [1] 305891 0
02/06/2020
Ethics approval number [1] 305891 0
RGS0000004051

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 101958 0
Mr Daniel Lightowler
Address 101958 0
Harry Perkins Institute of Medical Research
Fiona Stanley Hospital
11 Robin Warren Dr
MURDOCH WA 6150
Country 101958 0
Australia
Phone 101958 0
+61 8 61511154
Fax 101958 0
Email 101958 0
Daniel.Lightowler@uwa.edu.au
Contact person for public queries
Name 101959 0
Daniel Lightowler
Address 101959 0
Harry Perkins Institute of Medical Research
Fiona Stanley Hospital
11 Robin Warren Dr
MURDOCH WA 6150
Country 101959 0
Australia
Phone 101959 0
+61 8 61511154
Fax 101959 0
Email 101959 0
Daniel.Lightowler@uwa.edu.au
Contact person for scientific queries
Name 101960 0
Daniel Lightowler
Address 101960 0
Harry Perkins Institute of Medical Research
Fiona Stanley Hospital
11 Robin Warren Dr
MURDOCH WA 6150
Country 101960 0
Australia
Phone 101960 0
+61 8 61511154
Fax 101960 0
Email 101960 0
Daniel.Lightowler@uwa.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
IDP will remain confidential for this study


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
7857Study protocol    379725-(Uploaded-05-05-2020-00-28-41)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.