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Smoking CessationNCT05318651

Use Determinants of Smoking Cessation App

A study testing Kwit SAS - smoking cessation app in people with Smoking Cessation and Technology Acceptance Model, run by Paris Nanterre University at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Kwit SAS - smoking cessation app
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
255 participants
Where
1 siteFrance
Study dates
21 Mar 2022to 8 Aug 2022
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

France1 site

  • Universite Paris Nanterre, Epscp

    La Defense, Nanterre, 92001

Other trials in France

About this study

Official title: Determinants of Use of Mobile Apps for Smoking Cessation

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.

Read the detailed 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.

Being tested
Kwit SAS - smoking cessation app
Keywords
E health, smoking cessation, engagement determinants, intention to use, TAM model
Medical subject headings
Smoking Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Kwit SAS - smoking cessation appDevice

    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.

Study groups in NCT05318651
Study groupRoleWhat they receive
mobile app usersExperimentalNot described
Receives: Device: Kwit SAS - smoking cessation app

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. First Use

    The ratio of people accessing the app after giving them access to it.

    Measured: Day 1 - First use

  2. Mobile App Sustain Use (MASU)

    The ratio of times the application is accessed per week..

    Measured: 90 days post firs use of the mobile apps

  3. 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 :

    1. In the next week
    2. In the next month

    Measured: Day 15

  4. 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 :

    1. In the next week
    2. In the next month

    Measured: Day 30

  5. 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 :

    1. In the next 15 days
    2. In the next month

    Measured: Day 60

  6. 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 :

    1. In the next week
    2. In the next month

    Measured: Day 90

  7. 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)

    Measured: Day 15

  8. 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)

    Measured: Day 30

  9. 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)

    Measured: Day 60

  10. 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).

    Measured: Day 90

Secondary outcomes (10)

  1. Smoking profile (SP)

    The degree of dependence is assessed by the Fagerström Test, which is widely used.

    Measured: 1 day before the first use of the mobile app

  2. Craving intensity (CI)

    The visual analog scale or VAS was used to measure the average craving intensity .

    Measured: 1 day before before the first use of the mobile app

  3. Craving intensity (CI)

    The visual analog scale or VAS was used to measure the average craving intensity .

    Measured: Day 15

  4. Craving intensity (CI)

    The visual analog scale or VAS was used to measure the average craving intensity .

    Measured: Day 30

  5. Craving intensity (CI)

    The visual analog scale or VAS was used to measure the average craving intensity .

    Measured: Day 60

  6. Craving intensity (CI)

    The visual analog scale or VAS was used to measure the average craving intensity .

    Measured: Day 90

  7. 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)?

    Measured: Day 15

  8. 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)?

    Measured: Day 30

  9. 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)?

    Measured: Day 60

  10. 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)?

    Measured: Day 90

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2022
  2. Study start21 Mar 2022
  3. Primary completion21 Jun 2022
  4. Study completion8 Aug 2022

Resources

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
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
255 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05318651
Sponsor's protocol ID
A20273336
Status last verified
Aug 2022
First submitted
9 Mar 2022
Last updated
12 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28869775

  • 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.

    PubMed 27060875

  • 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.

    PubMed 31638271

  • 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.

    PubMed 32432186

  • 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.

    PubMed 26045249

  • 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.

    PubMed 31196062

  • 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.

    PubMed 25207512

  • 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.

    PubMed 15312915

  • 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.

    PubMed 25760773

  • 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.

    PubMed 33929336

  • 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.

    PubMed 30112741

  • Bustamante Perez LA, Romo L, Zerhouni O. Feasibility and Engagement of a Mobile App Preparation Program (Kwit) for Smoking Cessation in an Ecological Context: Quantitative Study. JMIR Mhealth Uhealth. 2024 Oct 2;12:e51025. doi: 10.2196/51025.

    PubMed 39357053

Questions about this trial

What is this clinical trial studying?

A study testing Kwit SAS - smoking cessation app in people with Smoking Cessation and Technology Acceptance Model, run by Paris Nanterre University at 1 site in France.

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 4 inclusion and 3 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: finished, as of the sponsor's last update on 12 Aug 2022. 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 France. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

First Use (time frame: Day 1 - First use). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05318651, which also lists 12 linked publications.

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 12 Aug 2022.

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