Effects of Message Content on Intention to Quit Smoking

Peripheral Artery Disease Clinical Trial

Official title:

Effects of Message Content on Intention to Quit Smoking in Smokers With Peripheral Artery Disease - a Randomised Controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02138032
• Other study ID #: CUNN-001-RCT
• Status: Terminated
• Phase: N/A
• First received: May 12, 2014
• Last updated: December 5, 2014
• Start date: May 2014
• Est. completion date: August 2014

Study information

• Verified date: December 2014
• Source: University of Stirling
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 17
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

Behavioral:
• Gains Framed Message

• Loss Framed Message

Locations

Country	Name	City	State
United Kingdom	Forth Valley Royal Hospital	Larbert	Falkirk

Sponsors (2)

Lead Sponsor	Collaborator
University of Stirling	NHS Forth Valley

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intention to quit smoking	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	No
Secondary	Stage of Change - smoking cessation	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	No
Secondary	Nicotine Dependence	Nicotine dependency will be measured using the standardised Fagerstrom Test for Nicotine Dependence (FTNP: Heatherton, Kozlowski, Frecker, & Fagerstrom, 1991)	Baseline and 3 weeks	No
Secondary	Outcome expectancy beliefs	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	No
Secondary	Self efficacy	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	No
Secondary	Risk Perception	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	No
Secondary	Health locus of control	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	No