Plain English Summary
Background and study aims
Unhealthy alcohol use is a major morbidity and mortality risk factor among students. Electronic screening and brief interventions have the potential to limit drinking and its consequences by reaching large parts of the population that do not necessarily access care. Computer or internet-based interventions targeting unhealthy alcohol use have shown promising results, but efficacy is limited. Smartphones offer an opportunity for interventions with multiple contacts at the user’s convenience, which may increase interventions’ efficacy. Smartphone applications also allow delivering interventions in context outside of reach of face-to-face or computerized intervention, including in situations in which people are drinking alcohol, for example at parties. Evidence of efficacy of computer or internet-based interventions cannot be extrapolated to smartphone applications: computers and smartphones are used differently, which may change their impact. Research is only starting in this area and efficacy of smartphone applications is largely unknown.
Aim: This project proposes a mixed methods approach to develop and test the efficacy of a smartphone application aimed at decreasing unhealthy alcohol use in students.
Who can participate?
Registered students aged 18 years or older, studying at one of the participating Schools/Universities (French part of Switzerland) who screen positive for unhealthy alcohol use.
What does the study involve?
Participating in 4 assessments over a 12 months period
Participants may be given access to a smartphone app with prevention material
What are the possible benefits and risks of participating?
There may be no direct benefit to participants. Potential benefits to participants include the possibility to reduce alcohol consumption and related problems; participants also may benefit from assessments and monitoring of alcohol use. They might take advantage of study participation to think about their behavior and life values and better know themselves.
The risks of serious adverse consequences as a result of study participation are relatively low. Participants might have concerns about confidentiality of sensitive information reported during the study assessments. The sensitive nature of some of the questions (e.g., alcohol-related) may cause participants discomfort.
Where is the study run from?
Lausanne University Hospital and University of Lausanne, Switzerland
When is the study starting and how long is it expected to run for?
April 2020 to June 2022
Who is funding the study?
Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung (Swiss National Science Foundation)
Who is the main contact?
Dr Nicolas Bertholet
Nicolas.Bertholet@chuv.ch
Trial website
Contact information
Type
Scientific
Primary contact
Dr Nicolas Bertholet
ORCID ID
http://orcid.org/0000-0001-5064-6377
Contact details
Lausanne University Hospital
Addiction Medicine
Bugnon 23A
Lausanne
1011
Switzerland
+41213140327
Nicolas.Bertholet@chuv.ch
Additional identifiers
EudraCT number
Nil known
ClinicalTrials.gov number
Nil known
Protocol/serial number
Swiss National Science Fondation 176295
Study information
Scientific title
Smartphone-based secondary prevention intervention for students with unhealthy alcohol use: qualitative study and randomized controlled trial
Acronym
ESAS
Study hypothesis
Participants in the intervention group (experimental condition: secondary prevention intervention delivered via a smartphone application) will report a smaller volume of drinking (measured with the mean number of drinks per week consumed over the past 30 days) at the 6-month follow-up compared to participants in the control group (receiving electronic assessment only).
Ethics approval
Approved 25/05/2018, Commission cantonale (VD) d'éthique de la recherche sur l'être humain (CER-VD) (Ethics committee of the Canton de Vaud, Avenue de Chailly 23, 1012 Lausanne, Switzerland; +41 21 316 18 30; secretariat.cer@vd.ch), ref: 2018-00560
Study design
Interventional randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Internet
Trial type
Prevention
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Unhealthy alcohol use
Intervention
Qualitative study: a member of the target population (i.e. fulfilling the randomized trial inclusion criteria) will be recruited to download and test a prototype of the smartphone-based intervention. After providing written informed consent, participants (n=20) are taking part in two rounds of qualitative assessments (individual semi-structured interviews). The smartphone-based intervention is modified after each round. An interview grid was developed for the project. All interviews are audio-recorded and transcribed verbatim. A conventional content analysis is conducted.
Phase I, development of the smartphone application and qualitative assessment: the piloted smartphone application will be further developed, notably to send messages to participants following pre-specified scenarios based on application usage. Modifications will be done in an iterative process. Two rounds of qualitative assessments (individual semi-structured interviews and focus group) will be conducted among members of the study population. Each round will lead to modifications in the smartphone application.
Phase II, randomized controlled trial: the application’s efficacy will be tested in a two parallel-group randomized controlled trial with a 1:1 allocation ratio with follow-up assessments at 3, 6 and 12 months.
Control (assessment only)
Intervention (assessment + smartphone application).
The entire randomized trial will be conducted electronically. Randomization is embedded within study website with full concealment of allocation. Electronic assessments at follow-up (3, 6, 12 months post baseline)
Intervention: providing access to a secondary prevention intervention targeting unhealthy alcohol use, delivered via a smartphone application
Intervention type
Other
Phase
Drug names
Primary outcome measure
Mean number of drinks per week over the past 30 days (electronic self-report), measured at 6 months
Secondary outcome measures
All electronic self-report, measured at 6 months:
1. Number of heavy drinking days over the past 30 days
2. Additional outcomes will be: maximum number of drinks on any day over the past 30 days, alcohol related consequences (measured with the Short Inventory of Problems (SIP-2R), and academic performance
Overall trial start date
30/03/2017
Overall trial end date
30/06/2022
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Registered student at one of the participating Schools/Universities (French part of Switzerland)
2. Age 18 and over
3. Positive screen for unhealthy alcohol use
4. Smartphone ownership
5. Willingness to complete follow-up assessments
Participant type
Other
Age group
Adult
Gender
Both
Target number of participants
1696
Participant exclusion criteria
1. Students who participated in the development of the smartphone application
Recruitment start date
01/11/2020
Recruitment end date
30/06/2021
Locations
Countries of recruitment
Switzerland
Trial participating centre
Lausanne University Hospital and University of Lausanne
Addiction Medicine
Bugnon 23A
Lausanne
1011
Switzerland
Sponsor information
Organisation
Lausanne University Hospital
Sponsor details
Addiction Medicine
Lausanne
1011
Switzerland
+41213148400
info@chuv.ch
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung
Alternative name(s)
Swiss National Science Foundation, Fonds National Suisse de la Recherche Scientifique, Fondo Nazionale Svizzero per la Ricerca Scientifica, Fonds National Suisse, Fondo Nazionale Svizzero, Schweizerischer Nationalfonds, SNF, SNSF, FNS
Funding Body Type
private sector organisation
Funding Body Subtype
Trusts, charities, foundations (both public and private)
Location
Switzerland
Results and Publications
Publication and dissemination plan
Results will be presented at international conference and published in peer reviewed journals.
IPD sharing statement:
The current data sharing plans for this study are unknown and will be available at a later date
Intention to publish date
30/06/2022
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list
2020 protocol in https://www.ncbi.nlm.nih.gov/pubmed/32066490 (added 24/02/2020)