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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05318651
Other study ID # A20273336
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 21, 2022
Est. completion date August 8, 2022

Study information

Verified date August 2022
Source Paris Nanterre University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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. Although 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.


Recruitment information / eligibility

Status Completed
Enrollment 255
Est. completion date August 8, 2022
Est. primary completion date June 21, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Participants must meet four inclusion criteria for the study: Inclusion criteria - Age: Be 18 years of age or older, - Smoking Status: consider themselves an active smoker - Motivation to quit: be willing to quit smoking, in the short and medium term. - 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. Exclusion criteria: - Participants must have a smartphone with an iOS or Android operating system - Access to the internet to complete the questionnaires - Download the application and receive the updates it offers.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Kwit SAS - smoking cessation app
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.

Locations

Country Name City State
France Universite Paris Nanterre, Epscp Paris La Defense Nanterre

Sponsors (1)

Lead Sponsor Collaborator
Paris Nanterre University

Country where clinical trial is conducted

France, 

References & Publications (11)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. Review. — View 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. — View 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:CD007078. doi: 10.1002/14651858.CD007078.pub5. Review. — View 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:CD006611. doi: 10.1002/14651858.CD006611.pub5. [Epub ahead of print] Review. — View 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:CD006611. doi: 10.1002/14651858.CD006611.pub4. Review. — View Citation

* Note: There are 11 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary First Use The ratio of people accessing the app after giving them access to it. Day 1 - First use
Primary Mobile App Sustain Use (MASU) The ratio of times the application is accessed per week.. 90 days post firs use of the mobile apps
Primary Mobile App Intention Use (MAIU): 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 :
In the next week
In the next month
Day 15
Primary Mobile App Intention Use (MAIU): 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 :
In the next week
In the next month
Day 30
Primary Mobile App Intention Use (MAIU): 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 :
In the next 15 days
In the next month
Day 60
Primary Mobile App Intention Use (MAIU): 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 :
In the next week
In the next month
Day 90
Primary Mobile App Satisfaction assessment (MAS): 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) Day 15
Primary Mobile App Satisfaction assessment (MAS): 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) Day 30
Primary Mobile App Satisfaction assessment (MAS): 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) Day 60
Primary Mobile App Satisfaction assessment (MAS): 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). Day 90
Secondary Smoking profile (SP) The degree of dependence is assessed by the Fagerström Test, which is widely used. 1 day before the first use of the mobile app
Secondary Craving intensity (CI) The visual analog scale or VAS was used to measure the average craving intensity . 1 day before before the first use of the mobile app
Secondary Craving intensity (CI) The visual analog scale or VAS was used to measure the average craving intensity . Day 15
Secondary Craving intensity (CI) The visual analog scale or VAS was used to measure the average craving intensity . Day 30
Secondary Craving intensity (CI) The visual analog scale or VAS was used to measure the average craving intensity . Day 60
Secondary Craving intensity (CI) The visual analog scale or VAS was used to measure the average craving intensity . Day 90
Secondary Behavior change : Smoking cessation Self-reported 15-day point prevalence smoking status. Since your first use of the app have you smoked a cigarette (even a puff)? Day 15
Secondary Behavior change : Smoking cessation Self-reported 30-day point prevalence smoking status. Since your first use of the app have you smoked a cigarette (even a puff)? Day 30
Secondary Behavior change : Smoking cessation Self-reported 60-day point prevalence smoking status. Since your first use of the app have you smoked a cigarette (even a puff)? Day 60
Secondary Behavior change : Smoking cessation Self-reported 90-day point prevalence smoking status. Since your first use of the app have you smoked a cigarette (even a puff)? Day 90
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