Peripheral Artery DiseaseNCT02138032
Effects of Message Content on Intention to Quit Smoking
A study testing Gains Framed Message and Loss Framed Message in people with Peripheral Artery Disease, run by University of Stirling at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Peripheral Artery Disease
- What is being tested?
- Gains Framed Message and Loss Framed Message
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2014to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Peripheral Artery Disease
- daily smoker
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Forth Valley Royal Hospital
Larbert, Falkirk, FK5 4WR
About this study
Official title: 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.
- Conditions
- Peripheral Artery Disease
- Being tested
- Gains Framed Message, Loss Framed Message
- Keywords
- message framing, smoking cessation, peripheral artery disease
- Medical subject headings
- Peripheral Arterial Disease, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gains Framed MessageBehavioural
Loss Framed MessageBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Gains Framed Message | Experimental | gains framed visual fridge magnet and information sheet about smoking cessation (benefits of quitting smoking) Receives: Behavioral: Gains Framed Message |
| Loss Framed Message | Experimental | loss framed visual fridge magnet and information sheet about smoking cessation (losses of continued smoking) Receives: Behavioral: Loss Framed Message |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: up to 3 weeks
Secondary outcomes (6)
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).
Measured: baseline and 3 weeks
Nicotine Dependence
Nicotine dependency will be measured using the standardised Fagerstrom Test for Nicotine Dependence (FTNP: Heatherton, Kozlowski, Frecker, \& Fagerstrom, 1991)
Measured: Baseline and 3 weeks
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.
Measured: Baseline and 3 weeks
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.
Measured: Baseline and 3 weeks
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.
Measured: baseline and 3 weeks
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).
Measured: baseline and 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2014 (estimated)
- Study startMay 2014
- Primary completionAug 2014
- Study completionAug 2014
Why it stopped: Student study which ended at the end of their course.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Stirling
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Forth Valley
- Responsible party
- Principal investigator, Maggie Cunningham, University of Stirling
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02138032
- Sponsor's protocol ID
- CUNN-001-RCT
- Status last verified
- Dec 2014
- First submitted
- 12 May 2014
- Last updated
- 8 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Message Content on Intention to Quit Smoking in Smokers With Peripheral Artery Disease - a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02138032
- Acronym / sponsor ID
- CUNN-001-RCT
- Conditions
- Peripheral Artery Disease
- Keywords
- message framing, smoking cessation, peripheral artery disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Student study which ended at the end of their course.
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of StirlingUniversity, hospital or other
- Collaborators
- NHS Forth Valley
- Study start
- May 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 14 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gains Framed Message | Experimental | Behavioral: Gains Framed Messagegains framed visual fridge magnet and information sheet about smoking cessation (benefits of quitting smoking) |
| Loss Framed Message | Experimental | Behavioral: Loss Framed Messageloss framed visual fridge magnet and information sheet about smoking cessation (losses of continued smoking) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Peripheral Artery Disease
- daily smoker
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gains Framed Message | Behavioural | Gains Framed Message |
| Loss Framed Message | Behavioural | Loss Framed Message |
Primary outcome
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).
6 secondary outcomes
Stage of Change - smoking cessation
Time frame: baseline and 3 weeks
Nicotine Dependence
Time frame: Baseline and 3 weeks
Outcome expectancy beliefs
Time frame: Baseline and 3 weeks
Self efficacy
Time frame: Baseline and 3 weeks
Risk Perception
Time frame: baseline and 3 weeks
Health locus of control
Time frame: baseline and 3 weeks
Results and safety
The study was stopped early (reason given: Student study which ended at the end of their course.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gains Framed Message and Loss Framed Message in people with Peripheral Artery Disease, run by University of Stirling at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Student study which ended at the end of their course.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intention to quit smoking (time frame: up to 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2014.