NCT02138032

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

May 12, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 14, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

December 8, 2014

Status Verified

December 1, 2014

Enrollment Period

3 months

First QC Date

May 12, 2014

Last Update Submit

December 5, 2014

Conditions

Keywords

message framingsmoking cessationperipheral artery disease

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (6)

  • Stage of Change - smoking cessation

    baseline and 3 weeks

  • Nicotine Dependence

    Baseline and 3 weeks

  • Outcome expectancy beliefs

    Baseline and 3 weeks

  • Self efficacy

    Baseline and 3 weeks

  • Risk Perception

    baseline and 3 weeks

  • +1 more secondary outcomes

Study Arms (2)

Gains Framed Message

EXPERIMENTAL

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

Behavioral: Gains Framed Message

Loss Framed Message

EXPERIMENTAL

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

Behavioral: Loss Framed Message

Interventions

Gains Framed Message
Loss Framed Message

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Peripheral Artery Disease
  • daily smoker

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Forth Valley Royal Hospital

Larbert, Falkirk, FK5 4WR, United Kingdom

Location

MeSH Terms

Conditions

Peripheral Arterial DiseaseSmoking Cessation

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular DiseasesHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer Health Psychology

Study Record Dates

First Submitted

May 12, 2014

First Posted

May 14, 2014

Study Start

May 1, 2014

Primary Completion

August 1, 2014

Study Completion

August 1, 2014

Last Updated

December 8, 2014

Record last verified: 2014-12

Locations