- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02138032
Effects of Message Content on Intention to Quit Smoking
December 5, 2014 updated by: Maggie Cunningham, University of Stirling
Effects of Message Content on Intention to Quit Smoking in Smokers With Peripheral Artery Disease - a Randomised Controlled Trial
Message framing involves "the presentation of choice alternatives, either in a positive or negative manner" (Huber, Neale, & Northcraft, 1987; p.137).
Positively framed health messages contain potential gains of participating/refraining in specific health behaviour.
Alternatively, negatively framed health messages contain potential losses of participating/refraining in specific health behaviour (Verlhiac, Chappe, & Meyer, 2011).
The primary aim and rationale of this study will be to investigate which type of framing has the greatest effect on intentions to quit smoking in patients with vascular arterial disease.
The secondary aim is to investigate what other factors may have an effect on intention to quit and also what factors play a part in a patient's intention to quit smoking.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
17
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Falkirk
-
Larbert, Falkirk, United Kingdom, FK5 4WR
- Forth Valley Royal Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Peripheral Artery Disease
- daily smoker
Exclusion Criteria:
- psychiatric illness or those who are not literate in English will be excluded from the study as informed consent cannot be obtained. Also, patients who are already participating in any other research involving smoking cessation will be excluded
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Gains Framed Message
gains framed visual fridge magnet and information sheet about smoking cessation (benefits of quitting smoking)
|
|
|
Experimental: Loss Framed Message
loss framed visual fridge magnet and information sheet about smoking cessation (losses of continued smoking)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intention to quit smoking
Time Frame: up to 3 weeks
|
Intention to quit smoking will be assessed by measuring the strength of the individual's intention with a mean score being calculated from the 3 questions asked.
This will generate a score between 1 and 7 with a higher score indicating a higher intention to quit smoking.
This measure has been used and reviewed in previous research (Francis et al, 2004).
|
up to 3 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Stage of Change - smoking cessation
Time Frame: baseline and 3 weeks
|
Secondly, the Stage of Change (SOC) of intention will be measured, with higher scores indicating a greater intention to quit smoking.
The corresponding scores will identify the SOC (1 =pre-contemplation, 2 = contemplation, 3 = preparation, 4 = action).
This measure has been adapted from a previous study which investigated stages of change in relation to smoking cessation (Fathelrahman et al. 2009).
|
baseline and 3 weeks
|
|
Nicotine Dependence
Time Frame: Baseline and 3 weeks
|
Nicotine dependency will be measured using the standardised Fagerstrom Test for Nicotine Dependence (FTNP: Heatherton, Kozlowski, Frecker, & Fagerstrom, 1991)
|
Baseline and 3 weeks
|
|
Outcome expectancy beliefs
Time Frame: Baseline and 3 weeks
|
Expectancy beliefs will be measured using a 10-item questionnaire which has been adapted from the Health Action Process Approach (HAPA) assessment tools (Schwarzer, 2007) by making the questions relevant to the specific patient group.
The questionnaire is comprised of two sub-scales: positive outcome expectancies (items 1, 3, 4, 6, 9) and negative outcome expectancies (items 2, 5, 7, 8, 10).
Each subscale sum scores will range from 5-20.
|
Baseline and 3 weeks
|
|
Self efficacy
Time Frame: Baseline and 3 weeks
|
Self-efficacy to quit smoking will be measured using a 10-item scale which has been previously used in a study investigating self-efficacy influences on the effects of framing in smoking cessation (Riet, Ruiter, Werrij, & de Vries, 2008).
Sum scores will range from 10 to 70 with higher scores indicating greater self-efficacy to quit smoking.
|
Baseline and 3 weeks
|
|
Risk Perception
Time Frame: baseline and 3 weeks
|
Risk perception of smoking will be measured using a 5-item questionnaire.
The items are similar to that used in a previous study (Clarke and Aish, 2002), however the questions have been adapted to increase the relevance for vascular arterial patients.
Sum scores will range from 5-35 with higher scores indicating a greater risk perception in regards to smoking.
|
baseline and 3 weeks
|
|
Health locus of control
Time Frame: baseline and 3 weeks
|
Health locus of control will be measured using the Multidimensional Health Locus of Control Scale - Form C (MHLC; Wallston, Stein & Smith, 1994).
|
baseline and 3 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2014
Primary Completion (Actual)
August 1, 2014
Study Completion (Actual)
August 1, 2014
Study Registration Dates
First Submitted
May 12, 2014
First Submitted That Met QC Criteria
May 13, 2014
First Posted (Estimate)
May 14, 2014
Study Record Updates
Last Update Posted (Estimate)
December 8, 2014
Last Update Submitted That Met QC Criteria
December 5, 2014
Last Verified
December 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CUNN-001-RCT
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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