Clinical trial NCT05318651: Use Determinants of Smoking Cessation App
Official title: Determinants of Use of Mobile Apps for Smoking Cessation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Technology Acceptance Model
CBT
Engagement
Keywords: E health
smoking cessation
engagement determinants
intention to use
TAM model
Lead sponsor: Paris Nanterre University
Sponsor class: OTHER
First posted: 2022-04-08
Enrollment: 255
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: First Use
timeFrame: Day 1 - First use
measure: Mobile App Sustain Use (MASU)
timeFrame: 90 days post firs use of the mobile apps
measure: Mobile App Intention Use (MAIU):
timeFrame: Day 15
measure: Mobile App Intention Use (MAIU):
timeFrame: Day 30
measure: Mobile App Intention Use (MAIU):
timeFrame: Day 60
measure: Mobile App Intention Use (MAIU):
timeFrame: Day 90
measure: Mobile App Satisfaction assessment (MAS):
timeFrame: Day 15
measure: Mobile App Satisfaction assessment (MAS):
timeFrame: Day 30
measure: Mobile App Satisfaction assessment (MAS):
timeFrame: Day 60
measure: Mobile App Satisfaction assessment (MAS):
timeFrame: Day 90
Secondary outcomes:
measure: Smoking profile (SP)
timeFrame: 1 day before the first use of the mobile app
measure: Craving intensity (CI)
timeFrame: 1 day before before the first use of the mobile app
measure: Craving intensity (CI)
timeFrame: Day 15
measure: Craving intensity (CI)
timeFrame: Day 30
measure: Craving intensity (CI)
timeFrame: Day 60
measure: Craving intensity (CI)
timeFrame: Day 90
measure: Behavior change : Smoking cessation
timeFrame: Day 15
measure: Behavior change : Smoking cessation
timeFrame: Day 30
measure: Behavior change : Smoking cessation
timeFrame: Day 60
measure: Behavior change : Smoking cessation
timeFrame: Day 90
Other outcomes:
Locations:
city: Paris La Defense
country: France
facility: Universite Paris Nanterre, Epscp
state: Nanterre
Study officials:
affiliation: Pr. de psychologie clinique UNIVERSITE PARIS NANTERRE
name: Lucia ROMO
role: PRINCIPAL_INVESTIGATOR
References:
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.
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