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Effects of Message Content on Intention to Quit Smoking

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ClinicalTrials.gov Identifier: NCT02138032
Recruitment Status : Terminated (Student study which ended at the end of their course.)
First Posted : May 14, 2014
Last Update Posted : December 8, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Peripheral Artery Disease Behavioral: Gains Framed Message Behavioral: Loss Framed Message

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Prevention
Official Title: Effects of Message Content on Intention to Quit Smoking in Smokers With Peripheral Artery Disease - a Randomised Controlled Trial
Study Start Date : May 2014
Primary Completion Date : August 2014
Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Gains Framed Message
gains framed visual fridge magnet and information sheet about smoking cessation (benefits of quitting smoking)
Behavioral: Gains Framed Message
Experimental: Loss Framed Message
loss framed visual fridge magnet and information sheet about smoking cessation (losses of continued smoking)
Behavioral: Loss Framed Message


Outcome Measures

Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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).

  2. 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)

  3. 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.

  4. 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.

  5. 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.

  6. 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).


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02138032


Locations
United Kingdom
Forth Valley Royal Hospital
Larbert, Falkirk, United Kingdom, FK5 4WR
Sponsors and Collaborators
University of Stirling
NHS Forth Valley
More Information

Responsible Party: Maggie Cunningham, Lecturer Health Psychology, University of Stirling
ClinicalTrials.gov Identifier: NCT02138032     History of Changes
Other Study ID Numbers: CUNN-001-RCT
First Posted: May 14, 2014    Key Record Dates
Last Update Posted: December 8, 2014
Last Verified: December 2014

Keywords provided by Maggie Cunningham, University of Stirling:
message framing
smoking cessation
peripheral artery disease

Additional relevant MeSH terms:
Peripheral Arterial Disease
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases