Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000016831
Ethics application status
Approved
Date submitted
21/12/2011
Date registered
4/01/2012
Date last updated
4/01/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A secondary prevention patient centred model for smoking cessation.
Scientific title
A pilot study of a nurse-led evidence based smoking cessation program in smokers with cardiovascular disease to develop a secondary prevention model of care for smoking cessation
Secondary ID [1] 279636 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Smoking cessation in cardiovascular patients. 285436 0
Secondary prevention. 285438 0
Condition category
Condition code
Cardiovascular 285617 285617 0 0
Coronary heart disease
Cardiovascular 285618 285618 0 0
Other cardiovascular diseases
Public Health 285621 285621 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Motivational interviewing:

Patients will be offered 6 face-to-face visits to a Registered Nurse, trained in smoking cessation techniques. The initial visit will be at least 90 minutes for assessment and counselling. Thereafter visits will be between 15 to 30 minutes for further counselling using evidence-based guidelines and carbon monoxide analysis to indicate abstinence. It is anticipated that most patients will remain engaged with the smoking cessation program for 3 months; however this could be extended to 6 months for those that need further support.
Intervention code [1] 283917 0
Behaviour
Intervention code [2] 283918 0
Prevention
Intervention code [3] 283919 0
Lifestyle
Comparator / control treatment
Before - after study design
Control group
Uncontrolled

Outcomes
Primary outcome [1] 286179 0
(O) The most favourable outcome after access to the evidence based smoking cessation program is smoking abstinence. Objective measures will be taken during the clinical visits using the Smokelyser in order to validate abstinence. Carbon monoxide level CO levels below 10ppm (parts per million) are considered reliable indicator of non-smoking. Questions during the contacts with the clinical nurses will provide additional subjective data on the quit-rate.
Timepoint [1] 286179 0
Visits are scheduled 2 weekly and run for 12 weeks with optional extension to 24 weeks (same schedule) if indicated.
Secondary outcome [1] 295318 0
(O) Participants are aware of national secondary prevention guidelines.
As part of the motivational interview technique, evidenced-based guidelines will be set in context with personalised risk factors of participants to motivate change and discuss knowledge of risk factors. Objective data like body weight, Body Mass Index and blood cholesterol levels will indicate uptake of secondary prevention guidelines.
Timepoint [1] 295318 0
0 month, 3 months, 6 months
Secondary outcome [2] 295319 0
(O) Early identification of risk factors.
Identification of vascular risk factors comprises the assessment of social life circumstances and general health. Risks screening also includes assessment and monitoring of depression / anxiety because of the association of coronary heart diseases, mental health issues and nicotine dependence. The following tools and measurements will quantify these risks

* Perceived social support; Instrument ESSI
* Perceived general health status; Instrument SF-12
* Depression and anxiety risk; Instrument HADS
* Height/weight/waist circumference measurements
Timepoint [2] 295319 0
1 month, 3 month, 6 month
Secondary outcome [3] 295320 0
(O) Patient satisfaction measures.
The overall patient satisfaction with our service will be measures with the Michigan Academic Consortium Patient Satisfaction Questionnaire.
Timepoint [3] 295320 0
After 3 months for participants who quit smoking after the 12 weeks schedule.

After 6 months for patients who did not quit smoking after 3 months and did the 3 months cycle again.

Eligibility
Key inclusion criteria
1. Primary diagnosis of one or more of the following: stable angina, atherosclerotic related events such as acute coronary syndrome, coronary artery bypass grafts, stroke, transient ischemic attack, or peripheral vascular disease.
2. Aged 18 and above
3. Telephone access
4. Current smoker
5. Fluent in English
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Diagnosed with a terminal illness
2. Cognitive impairment that may impact upon ability to participate in the trial
3. Participant is housebound
4. Participation in other research trial that may interfere with the trial
5. Inability to give informed consent
6. Any other factor impacting upon ability to give informed consent or participate in the study

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
20/12/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284417 0
Hospital
Name [1] 284417 0
St Vincent's Hospital Melbourne
Country [1] 284417 0
Australia
Primary sponsor type
Hospital
Name
St Vincent’s Hospital Melbourne
Address
41 Victoria Parade
Fitzroy VIC 3065
Country
Australia
Secondary sponsor category [1] 283345 0
University
Name [1] 283345 0
Australian Catholic University
Address [1] 283345 0
115 Victoria Parade
Fitzroy Victoria 3065
Country [1] 283345 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286393 0
HREC STV Melbourne
Ethics committee address [1] 286393 0
Ethics committee country [1] 286393 0
Australia
Date submitted for ethics approval [1] 286393 0
Approval date [1] 286393 0
11/05/2011
Ethics approval number [1] 286393 0
04711

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33558 0
Address 33558 0
Country 33558 0
Phone 33558 0
Fax 33558 0
Email 33558 0
Contact person for public queries
Name 16805 0
Karen Daws
Address 16805 0
St Vincent's / ACU Centre for Nursing Research
VECCI Building
Locked Bag 4115
Fitzroy MDS 3065
Victoria
Country 16805 0
Australia
Phone 16805 0
+61 3 9953 3701
Fax 16805 0
+61 3 9662 1857
Email 16805 0
[email protected]
Contact person for scientific queries
Name 7733 0
Karen Daws
Address 7733 0
St Vincent's / ACU Centre for Nursing Research
VECCI Building
Locked Bag 4115
Fitzroy MDS 3065
Victoria
Country 7733 0
Australia
Phone 7733 0
+61 3 9953 3701
Fax 7733 0
+61 3 9662 1857
Email 7733 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



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.