Effects of Message Content on Intention to Quit Smoking

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2014 by University of Stirling
Sponsor:
Collaborator:
NHS Forth Valley
Information provided by (Responsible Party):
Maggie Cunningham, University of Stirling
ClinicalTrials.gov Identifier:
NCT02138032
First received: May 12, 2014
Last updated: May 13, 2014
Last verified: May 2014
  Purpose

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 Intervention
Peripheral Artery Disease
Behavioral: Gains Framed Message
Behavioral: Loss Framed Message

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Caregiver)
Primary Purpose: Prevention
Official Title: Effects of Message Content on Intention to Quit Smoking in Smokers With Peripheral Artery Disease - a Randomised Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of Stirling:

Primary Outcome Measures:
  • Intention to quit smoking [ Time Frame: up to 3 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline and 3 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 3 weeks ] [ Designated as safety issue: No ]
    Nicotine dependency will be measured using the standardised Fagerstrom Test for Nicotine Dependence (FTNP: Heatherton, Kozlowski, Frecker, & Fagerstrom, 1991)

  • Outcome expectancy beliefs [ Time Frame: Baseline and 3 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and 3 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline and 3 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline and 3 weeks ] [ Designated as safety issue: No ]
    Health locus of control will be measured using the Multidimensional Health Locus of Control Scale - Form C (MHLC; Wallston, Stein & Smith, 1994).


Estimated Enrollment: 140
Study Start Date: May 2014
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02138032

Locations
United Kingdom
Forth Valley Royal Hospital Not yet recruiting
Larbert, Falkirk, United Kingdom, FK5 4WR
Contact: Richard Holdsworth, MD    +44 1324 566000      
Sponsors and Collaborators
University of Stirling
NHS Forth Valley
  More Information

No publications provided

Responsible Party: Maggie Cunningham, Lecturer Health Psychology, University of Stirling
ClinicalTrials.gov Identifier: NCT02138032     History of Changes
Other Study ID Numbers: CUNN-001-RCT
Study First Received: May 12, 2014
Last Updated: May 13, 2014
Health Authority: United Kingdom: National Health Service

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

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

ClinicalTrials.gov processed this record on July 24, 2014