Ignite Creation Date:
2025-12-24 @ 9:26 PM
Ignite Modification Date:
2026-01-05 @ 5:38 PM
Study NCT ID:
NCT02138032
Status:
TERMINATED
Last Update Posted:
2014-12-08
First Post:
2014-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Message Content on Intention to Quit Smoking
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}, {'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'whyStopped': 'Student study which ended at the end of their course.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-05', 'studyFirstSubmitDate': '2014-05-12', 'studyFirstSubmitQcDate': '2014-05-13', 'lastUpdatePostDateStruct': {'date': '2014-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-05-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intention to quit smoking', 'timeFrame': 'up to 3 weeks', '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)."}], 'secondaryOutcomes': [{'measure': 'Stage of Change - smoking cessation', 'timeFrame': 'baseline and 3 weeks', '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).'}, {'measure': 'Nicotine Dependence', 'timeFrame': 'Baseline and 3 weeks', 'description': 'Nicotine dependency will be measured using the standardised Fagerstrom Test for Nicotine Dependence (FTNP: Heatherton, Kozlowski, Frecker, \\& Fagerstrom, 1991)'}, {'measure': 'Outcome expectancy beliefs', 'timeFrame': 'Baseline and 3 weeks', '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.'}, {'measure': 'Self efficacy', 'timeFrame': 'Baseline and 3 weeks', '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.'}, {'measure': 'Risk Perception', 'timeFrame': 'baseline and 3 weeks', '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.'}, {'measure': 'Health locus of control', 'timeFrame': 'baseline and 3 weeks', 'description': 'Health locus of control will be measured using the Multidimensional Health Locus of Control Scale - Form C (MHLC; Wallston, Stein \\& Smith, 1994).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['message framing', 'smoking cessation', 'peripheral artery disease'], 'conditions': ['Peripheral Artery Disease']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Peripheral Artery Disease\n* daily smoker\n\nExclusion Criteria:\n\n* 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'}, 'identificationModule': {'nctId': 'NCT02138032', 'briefTitle': 'Effects of Message Content on Intention to Quit Smoking', 'organization': {'class': 'OTHER', 'fullName': 'University of Stirling'}, 'officialTitle': 'Effects of Message Content on Intention to Quit Smoking in Smokers With Peripheral Artery Disease - a Randomised Controlled Trial', 'orgStudyIdInfo': {'id': 'CUNN-001-RCT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Gains Framed Message', 'description': 'gains framed visual fridge magnet and information sheet about smoking cessation (benefits of quitting smoking)', 'interventionNames': ['Behavioral: Gains Framed Message']}, {'type': 'EXPERIMENTAL', 'label': 'Loss Framed Message', 'description': 'loss framed visual fridge magnet and information sheet about smoking cessation (losses of continued smoking)', 'interventionNames': ['Behavioral: Loss Framed Message']}], 'interventions': [{'name': 'Gains Framed Message', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Gains Framed Message']}, {'name': 'Loss Framed Message', 'type': 'BEHAVIORAL', 'armGroupLabels': ['Loss Framed Message']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'FK5 4WR', 'city': 'Larbert', 'state': 'Falkirk', 'country': 'United Kingdom', 'facility': 'Forth Valley Royal Hospital', 'geoPoint': {'lat': 56.02246, 'lon': -3.82872}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Stirling', 'class': 'OTHER'}, 'collaborators': [{'name': 'NHS Forth Valley', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer Health Psychology', 'investigatorFullName': 'Maggie Cunningham', 'investigatorAffiliation': 'University of Stirling'}}}}