- ICH GCP
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- Klinische proef NCT01958398
Brief Alcohol Interventions With Mobile Phone Applications for University Students: A Randomized Controlled Trial
Objectives: This study evaluates the efficacy of two mobile phone applications, Promillekoll and PartyPlanner among university government members at two universities in Stockholm, Sweden. The design is a three-armed randomized controlled design, and outcomes are measured in terms of changes in problematic alcohol use at follow up 7 weeks after study initiation and baseline data gathering. Both the Promillekoll and PartyPlanner apps feature real time registration of alcohol consumption and giving feedback of estimated blood alcohol concentration levels. Both apps inform and warn the user when the estimated alcohol level is above 0.6%, a level set that is below risky consumption levels. PartyPlanner additionally provides the possibility of simulating and planning an alcohol consumption event in advance and later on comparing it with the real time registration at the event.
Method: Participants with problematic alcohol use (AUDIT >7 for men and >5 for women) are randomized into one of three groups: 1. Access to Promillekoll, 2. Access to PartyPlanner and 3. Control group. Outcomes on alcohol use as well as information on the users' satisfaction with the app assigned to them gathered after 7 weeks.
The hypotheses are: 1. The groups receiving the Promillekoll and PartyPlanner interventions will reduce their alcohol use to a larger extent than the control group at follow-up compared to the baseline level. 2. The addition of the possibility to plan events beforehand (PartyPlanner) will lead to an increased decrease in alcohol consumption to only real-time use (Promillekoll).
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Background Brief interventions via the internet have been shown to reduce university students' alcohol intake. This study tested two smartphone applications (apps) targeting drinking choices on party occasions, with the goal of reducing problematic alcohol intake among Swedish university students.
Methods Students were recruited via e-mails sent to student union members at two universities. Those who gave informed consent, had a smartphone, and showed risky alcohol consumption according to the Alcohol Use Disorders Identification Test (AUDIT) were randomized into three groups. Group 1 had access to the Swedish government alcohol monopoly's app, Promillekoll, offering real-time estimated blood alcohol concentration (eBAC) calculation; Group 2 had access to a web-based app, PartyPlanner, developed by the research group, offering real-time eBAC calculation with planning and follow-up functions; and Group 3 participants were controls. Follow-up was conducted at 7 weeks.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Stockholm, Zweden, 17176
- Karolinska Institutet, department of clinical neuroscience
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Access to a smartphone running iOS or Android OS.
- AUDIT >7 for men or AUDIT >5 for women.
Exclusion Criteria:
- AUDIT <8 (men) or <6 (women)
- No access to a smartphone running iOS or Android OS.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Geen tussenkomst: Controle
Onbehandelde controlegroep
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Experimenteel: Promillekoll
Smartphone app monitoring alcohol use with feedback.
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Smartphone app monitoring alcohol use with feedback.
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Experimenteel: PartyPlanner
Smartphone-adapted web based app for simulating an event with alcohol consumption in advance, real time monitoring alcohol use with feedback during the event and the possibility to compare these two.
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Smartphone-adapted web based app for simulating an event with alcohol consumption in advance, real time monitoring alcohol use with feedback during the event and the possibility to compare these two.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Change in estimated Blood Alcohol Concentration (eBAC)
Tijdsspanne: 7 weeks
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Change in Blood Alcohol Concentration estimated using Widmark's formula for Blood Alcohol Concentration estimation.
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7 weeks
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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AUDIT-C
Tijdsspanne: 7 weeks
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The change in score for the first three AUDIT questions, as a measure of alcohol consumption only, referred to as the AUDIT-C.
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7 weeks
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Alcohol Use Disorders Identification Test (AUDIT)
Tijdsspanne: 7 weeks
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Change in total AUDIT score, as a summarized measure of alcohol use (including alcohol consumption and alcohol-related problems).
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7 weeks
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Anne H Berman, PhD, Karolinska Institutet
Publicaties en nuttige links
Nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2012/1126-31/1
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