Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2026-02-23 @ 4:54 AM
Study NCT ID:
NCT05318651
Status:
COMPLETED
Last Update Posted:
2022-08-12
First Post:
2022-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Use Determinants of Smoking Cessation App
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016540', 'term': 'Smoking Cessation'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 255}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2022-08-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-09', 'studyFirstSubmitDate': '2022-03-09', 'studyFirstSubmitQcDate': '2022-04-01', 'lastUpdatePostDateStruct': {'date': '2022-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'First Use', 'timeFrame': 'Day 1 - First use', 'description': 'The ratio of people accessing the app after giving them access to it.'}, {'measure': 'Mobile App Sustain Use (MASU)', 'timeFrame': '90 days post firs use of the mobile apps', 'description': 'The ratio of times the application is accessed per week..'}, {'measure': 'Mobile App Intention Use (MAIU):', 'timeFrame': 'Day 15', 'description': 'Questionaire : please specify by selecting a number from 1 to 3, with 1 being "Just once", 2 being "Daily" and 3 being "Several times a day", how often you expect to use this application in the course of :\n\n1. In the next week\n2. In the next month'}, {'measure': 'Mobile App Intention Use (MAIU):', 'timeFrame': 'Day 30', 'description': 'Questionaire : please specify by selecting a number from 1 to 3, with 1 being "Just once", 2 being "Daily" and 3 being "Several times a day", how often you expect to use this application in the course of :\n\n1. In the next week\n2. In the next month'}, {'measure': 'Mobile App Intention Use (MAIU):', 'timeFrame': 'Day 60', 'description': 'Questionaire : please specify by selecting a number from 1 to 3, with 1 being "Just once", 2 being "Daily" and 3 being "Several times a day", how often you expect to use this application in the course of :\n\n1. In the next 15 days\n2. In the next month'}, {'measure': 'Mobile App Intention Use (MAIU):', 'timeFrame': 'Day 90', 'description': 'Questionaire : Please specify by selecting a number from 1 to 3, with 1 being "Just once", 2 being "Daily" and 3 being "Several times a day", how often you expect to use this application in the course of :\n\n1. In the next week\n2. In the next month'}, {'measure': 'Mobile App Satisfaction assessment (MAS):', 'timeFrame': 'Day 15', 'description': 'The Mobile App Ratting Scale (MARS) scale is a multidimensional metric that ranks and assesses the quality of mobile apps. The MARS total score can be used to evaluate and compare the quality of an application with others. The total score is calculated as the average of its five categories: user engagement, functionality, aesthetics, information and subjective quality. Each category is rated on a five-point scale ranging from inadequate-1 to excellent-5 (25).This scale has been used previously to assess the quality of smoking cessation apps in the Australian market with high inter-rater reliability (ICC =0.807)'}, {'measure': 'Mobile App Satisfaction assessment (MAS):', 'timeFrame': 'Day 30', 'description': 'The Mobile App Ratting Scale (MARS) scale is a multidimensional metric that ranks and assesses the quality of mobile apps. The MARS total score can be used to evaluate and compare the quality of an application with others. The total score is calculated as the average of its five categories: user engagement, functionality, aesthetics, information and subjective quality. Each category is rated on a five-point scale ranging from inadequate-1 to excellent-5 (25).This scale has been used previously to assess the quality of smoking cessation apps in the Australian market with high inter-rater reliability (ICC =0.807)'}, {'measure': 'Mobile App Satisfaction assessment (MAS):', 'timeFrame': 'Day 60', 'description': 'The Mobile App Ratting Scale (MARS) scale is a multidimensional metric that ranks and assesses the quality of mobile apps. The MARS total score can be used to evaluate and compare the quality of an application with others. The total score is calculated as the average of its five categories: user engagement, functionality, aesthetics, information and subjective quality. Each category is rated on a five-point scale ranging from inadequate-1 to excellent-5 (25).This scale has been used previously to assess the quality of smoking cessation apps in the Australian market with high inter-rater reliability (ICC =0.807)'}, {'measure': 'Mobile App Satisfaction assessment (MAS):', 'timeFrame': 'Day 90', 'description': 'The Mobile App Ratting Scale (MARS) scale is a multidimensional metric that ranks and assesses the quality of mobile apps. The MARS total score can be used to evaluate and compare the quality of an application with others. The total score is calculated as the average of its five categories: user engagement, functionality, aesthetics, information and subjective quality. Each category is rated on a five-point scale ranging from inadequate-1 to excellent-5.This scale has been used previously to assess the quality of smoking cessation apps in the Australian market with high inter-rater reliability (ICC =0.807).'}], 'secondaryOutcomes': [{'measure': 'Smoking profile (SP)', 'timeFrame': '1 day before the first use of the mobile app', 'description': 'The degree of dependence is assessed by the Fagerström Test, which is widely used.'}, {'measure': 'Craving intensity (CI)', 'timeFrame': '1 day before before the first use of the mobile app', 'description': 'The visual analog scale or VAS was used to measure the average craving intensity .'}, {'measure': 'Craving intensity (CI)', 'timeFrame': 'Day 15', 'description': 'The visual analog scale or VAS was used to measure the average craving intensity .'}, {'measure': 'Craving intensity (CI)', 'timeFrame': 'Day 30', 'description': 'The visual analog scale or VAS was used to measure the average craving intensity .'}, {'measure': 'Craving intensity (CI)', 'timeFrame': 'Day 60', 'description': 'The visual analog scale or VAS was used to measure the average craving intensity .'}, {'measure': 'Craving intensity (CI)', 'timeFrame': 'Day 90', 'description': 'The visual analog scale or VAS was used to measure the average craving intensity .'}, {'measure': 'Behavior change : Smoking cessation', 'timeFrame': 'Day 15', 'description': 'Self-reported 15-day point prevalence smoking status. Since your first use of the app have you smoked a cigarette (even a puff)?'}, {'measure': 'Behavior change : Smoking cessation', 'timeFrame': 'Day 30', 'description': 'Self-reported 30-day point prevalence smoking status. Since your first use of the app have you smoked a cigarette (even a puff)?'}, {'measure': 'Behavior change : Smoking cessation', 'timeFrame': 'Day 60', 'description': 'Self-reported 60-day point prevalence smoking status. Since your first use of the app have you smoked a cigarette (even a puff)?'}, {'measure': 'Behavior change : Smoking cessation', 'timeFrame': 'Day 90', 'description': 'Self-reported 90-day point prevalence smoking status. Since your first use of the app have you smoked a cigarette (even a puff)?'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['E health', 'smoking cessation', 'engagement determinants', 'intention to use', 'TAM model'], 'conditions': ['Smoking Cessation', 'Technology Acceptance Model', 'CBT', 'Engagement']}, 'referencesModule': {'references': [{'pmid': '28869775', 'type': 'BACKGROUND', 'citation': 'Taylor GMJ, Dalili MN, Semwal M, Civljak M, Sheikh A, Car J. Internet-based interventions for smoking cessation. Cochrane Database Syst Rev. 2017 Sep 4;9(9):CD007078. doi: 10.1002/14651858.CD007078.pub5.'}, {'pmid': '27060875', 'type': 'BACKGROUND', 'citation': 'Whittaker R, McRobbie H, Bullen C, Rodgers A, Gu Y. Mobile phone-based interventions for smoking cessation. Cochrane Database Syst Rev. 2016 Apr 10;4(4):CD006611. doi: 10.1002/14651858.CD006611.pub4.'}, {'pmid': '31638271', 'type': 'BACKGROUND', 'citation': 'Whittaker R, McRobbie H, Bullen C, Rodgers A, Gu Y, Dobson R. Mobile phone text messaging and app-based interventions for smoking cessation. Cochrane Database Syst Rev. 2019 Oct 22;10(10):CD006611. doi: 10.1002/14651858.CD006611.pub5.'}, {'pmid': '32432186', 'type': 'BACKGROUND', 'citation': 'Regmi K, Kassim N, Ahmad N, Tuah NA. Effectiveness of Mobile Apps for Smoking Cessation: A Review. Tob Prev Cessat. 2017 Apr 12;3:12. doi: 10.18332/tpc/70088. eCollection 2017.'}, {'pmid': '26045249', 'type': 'BACKGROUND', 'citation': 'Hoeppner BB, Hoeppner SS, Seaboyer L, Schick MR, Wu GW, Bergman BG, Kelly JF. How Smart are Smartphone Apps for Smoking Cessation? A Content Analysis. Nicotine Tob Res. 2016 May;18(5):1025-31. doi: 10.1093/ntr/ntv117. Epub 2015 Jun 4.'}, {'pmid': '31196062', 'type': 'BACKGROUND', 'citation': 'Rajani NB, Weth D, Mastellos N, Filippidis FT. Adherence of popular smoking cessation mobile applications to evidence-based guidelines. BMC Public Health. 2019 Jun 13;19(1):743. doi: 10.1186/s12889-019-7084-7.'}, {'pmid': '25207512', 'type': 'BACKGROUND', 'citation': 'Cho J, Quinlan MM, Park D, Noh GY. Determinants of adoption of smartphone health apps among college students. Am J Health Behav. 2014 Nov;38(6):860-70. doi: 10.5993/AJHB.38.6.8.'}, {'pmid': '15312915', 'type': 'BACKGROUND', 'citation': 'Cotten SR, Gupta SS. Characteristics of online and offline health information seekers and factors that discriminate between them. Soc Sci Med. 2004 Nov;59(9):1795-806. doi: 10.1016/j.socscimed.2004.02.020.'}, {'pmid': '25760773', 'type': 'BACKGROUND', 'citation': 'Stoyanov SR, Hides L, Kavanagh DJ, Zelenko O, Tjondronegoro D, Mani M. Mobile app rating scale: a new tool for assessing the quality of health mobile apps. JMIR Mhealth Uhealth. 2015 Mar 11;3(1):e27. doi: 10.2196/mhealth.3422.'}, {'pmid': '33929336', 'type': 'BACKGROUND', 'citation': 'Rajani NB, Mastellos N, Filippidis FT. Self-Efficacy and Motivation to Quit of Smokers Seeking to Quit: Quantitative Assessment of Smoking Cessation Mobile Apps. JMIR Mhealth Uhealth. 2021 Apr 30;9(4):e25030. doi: 10.2196/25030.'}, {'pmid': '30112741', 'type': 'BACKGROUND', 'citation': 'Rahimi B, Nadri H, Lotfnezhad Afshar H, Timpka T. A Systematic Review of the Technology Acceptance Model in Health Informatics. Appl Clin Inform. 2018 Jul;9(3):604-634. doi: 10.1055/s-0038-1668091. Epub 2018 Aug 15.'}]}, 'descriptionModule': {'briefSummary': 'The development of mobile applications ("mobile apps") is steadily increasing and appears to be a promising treatment method to help people change unwanted behaviors or maintain a regular relationship with the medical system. Mobile apps aimed at smoking cessation have been shown to be effective. However, if a treatment is not used regularly, it will not have the desired effect. The main objective of this study is to identify what makes a person decide to use a smoking cessation app and to do so regularly. The second objective is to determine what is necessary to achieve long-term change with a mobile app.', 'detailedDescription': 'Despite the significant decrease in tobacco consumption in France (30% in 2000 vs. 25.4% in 2018), the prevalence of smokers aged 18 to 75 years is still a public issue. Among the new solutions proposed, mobile applications ("mobile apps") seem to be a promising treatment modality. Several advantages to their use are recognized for patients, health professionals and the health system itself. Mobile applications allow accessibility to care and information, the possibility of transposing several proven effective therapeutic principles, the possibility of integrating certain forms of information transmission such as messaging, behavioural feedback and audiovisual media.\n\nAlthough mobile app development is a growing market, knowledge about the determinants of intention to use this type of technology is very limited, especially for smoking cessation apps. The investigators propose a theoretical model to examine what determines the regular use of mobile apps for smoking cessation among those who want to quit. The investigators use the TAMII model and the operational variables used in a more general study on e-health applications. A chronological organisation based on a three-part behavioural model (antecedent, target behaviour and outcome) is added to the TAMII model. The main objective is to identify the factors of Mobila App Sustain Use (MASU). All definitions of TAM-II will be used : perceived usefulness (PU), perceived ease of use (PEOU) and social norm (SN), as well as the definitions proposed by Choi et al (2014) on the predictors of PU, PEOU and SN.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Participants must meet four inclusion criteria for the study:\n\nInclusion criteria\n\n* Age: Be 18 years of age or older,\n* Smoking Status: consider themselves an active smoker\n* Motivation to quit: be willing to quit smoking, in the short and medium term.\n* Agreement to participate: They must also agree to participate in the study. They will have read the information note where the procedure is described; the researchers presented and their rights to withdraw from the study are recalled.\n\nExclusion criteria:\n\n* Participants must have a smartphone with an iOS or Android operating system\n* Access to the internet to complete the questionnaires\n* Download the application and receive the updates it offers.'}, 'identificationModule': {'nctId': 'NCT05318651', 'briefTitle': 'Use Determinants of Smoking Cessation App', 'organization': {'class': 'OTHER', 'fullName': 'Paris Nanterre University'}, 'officialTitle': 'Determinants of Use of Mobile Apps for Smoking Cessation', 'orgStudyIdInfo': {'id': 'A20273336'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'mobile app users', 'interventionNames': ['Device: Kwit SAS - smoking cessation app']}], 'interventions': [{'name': 'Kwit SAS - smoking cessation app', 'type': 'DEVICE', 'description': 'Kwit is a mobile app for smoking cessation. Different CBT techniques are used by the app already been proved as effective : Case analysis craving tool, Achievements badges,Diary, Goal (outcome) setting, A 9-steps preparation program, psychological education, Emotional monitoring, Access to groups on social networks, different strategies ( NRT/water/meditation), Motivational cards.', 'armGroupLabels': ['mobile app users']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92001', 'city': 'La Defense', 'state': 'Nanterre', 'country': 'France', 'facility': 'Universite Paris Nanterre, Epscp', 'geoPoint': {'lat': 48.89198, 'lon': 2.23881}}], 'overallOfficials': [{'name': 'Lucia ROMO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pr. de psychologie clinique UNIVERSITE PARIS NANTERRE'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Paris Nanterre University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Luz BUSTAMANTE', 'investigatorAffiliation': 'Paris Nanterre University'}}}}