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Sponsor study identifier
interventional
4,408
1 country
1
Study Start
February 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2013
Actual (reported)Study Completion
May 2013
Actual (reported)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).
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2013
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2013
Date type not reportedThis date has not been verified as actual or estimated.
May 2013
Actual (reported)May 2013
Actual (reported)October 6, 2013
Actual (reported)October 9, 2013
Actual (reported)Change in estimated Blood Alcohol Concentration (eBAC)
Change in Blood Alcohol Concentration estimated using Widmark's formula for Blood Alcohol Concentration estimation.
7 weeks
AUDIT-C
7 weeks
Alcohol Use Disorders Identification Test (AUDIT)
7 weeks
Smartphone app monitoring alcohol use with feedback.
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.
Untreated control group
Smartphone app monitoring alcohol use with feedback.
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.
Karolinska institutet, Department of Clinical Neuroscience
Stockholm, 17176, Sweden
Gajecki M, Berman AH, Sinadinovic K, Rosendahl I, Andersson C. Mobile phone brief intervention applications for risky alcohol use among university students: a randomized controlled study. Addict Sci Clin Pract. 2014 Jul 2;9(1):11. doi: 10.1186/1940-0640-9-11.
Anne H Berman, PhD
Karolinska Institutet
4,408 participants (actual enrollment reported by the registry).
First Submitted
October 6, 2013
First Posted
October 9, 2013
Study Start
February 2013
Date type not reportedThis date has not been verified as actual or estimated.
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Primary Completion
May 2013
Actual (reported)Study Completion
May 2013
Actual (reported)Last Updated
April 30, 2019
Record last verified: 2019-04
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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