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Effects of Message Content on Intention to Quit Smoking

Primary Purpose

Peripheral Artery Disease

Status
Terminated
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Gains Framed Message
Loss Framed Message
Sponsored by
University of Stirling
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Peripheral Artery Disease focused on measuring message framing, smoking cessation, peripheral artery disease

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Forth Valley Royal Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Gains Framed Message

Loss Framed Message

Arm Description

gains framed visual fridge magnet and information sheet about smoking cessation (benefits of quitting smoking)

loss framed visual fridge magnet and information sheet about smoking cessation (losses of continued smoking)

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
Nicotine Dependence
Nicotine dependency will be measured using the standardised Fagerstrom Test for Nicotine Dependence (FTNP: Heatherton, Kozlowski, Frecker, & Fagerstrom, 1991)
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.
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.
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.
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).

Full Information

First Posted
May 12, 2014
Last Updated
December 5, 2014
Sponsor
University of Stirling
Collaborators
NHS Forth Valley
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1. Study Identification

Unique Protocol Identification Number
NCT02138032
Brief Title
Effects of Message Content on Intention to Quit Smoking
Official Title
Effects of Message Content on Intention to Quit Smoking in Smokers With Peripheral Artery Disease - a Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Terminated
Why Stopped
Student study which ended at the end of their course.
Study Start Date
May 2014 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Stirling
Collaborators
NHS Forth Valley

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Artery Disease
Keywords
message framing, smoking cessation, peripheral artery disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gains Framed Message
Arm Type
Experimental
Arm Description
gains framed visual fridge magnet and information sheet about smoking cessation (benefits of quitting smoking)
Arm Title
Loss Framed Message
Arm Type
Experimental
Arm Description
loss framed visual fridge magnet and information sheet about smoking cessation (losses of continued smoking)
Intervention Type
Behavioral
Intervention Name(s)
Gains Framed Message
Intervention Type
Behavioral
Intervention Name(s)
Loss Framed Message
Primary Outcome Measure Information:
Title
Intention to quit smoking
Description
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).
Time Frame
up to 3 weeks
Secondary Outcome Measure Information:
Title
Stage of Change - smoking cessation
Description
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).
Time Frame
baseline and 3 weeks
Title
Nicotine Dependence
Description
Nicotine dependency will be measured using the standardised Fagerstrom Test for Nicotine Dependence (FTNP: Heatherton, Kozlowski, Frecker, & Fagerstrom, 1991)
Time Frame
Baseline and 3 weeks
Title
Outcome expectancy beliefs
Description
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.
Time Frame
Baseline and 3 weeks
Title
Self efficacy
Description
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.
Time Frame
Baseline and 3 weeks
Title
Risk Perception
Description
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.
Time Frame
baseline and 3 weeks
Title
Health locus of control
Description
Health locus of control will be measured using the Multidimensional Health Locus of Control Scale - Form C (MHLC; Wallston, Stein & Smith, 1994).
Time Frame
baseline and 3 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Forth Valley Royal Hospital
City
Larbert
State/Province
Falkirk
ZIP/Postal Code
FK5 4WR
Country
United Kingdom

12. IPD Sharing Statement

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Effects of Message Content on Intention to Quit Smoking

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