NCT01958398

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,408

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 6, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 9, 2013

Completed
Last Updated

April 30, 2019

Status Verified

April 1, 2019

Enrollment Period

3 months

First QC Date

October 6, 2013

Last Update Submit

April 28, 2019

Conditions

Keywords

Randomized Controlled TrialAlcoholInternetMobile phoneScreeningBrief intervention

Outcome Measures

Primary Outcomes (1)

  • Change in estimated Blood Alcohol Concentration (eBAC)

    Change in Blood Alcohol Concentration estimated using Widmark's formula for Blood Alcohol Concentration estimation.

    7 weeks

Secondary Outcomes (2)

  • AUDIT-C

    7 weeks

  • Alcohol Use Disorders Identification Test (AUDIT)

    7 weeks

Study Arms (3)

Promillekoll

EXPERIMENTAL

Smartphone app monitoring alcohol use with feedback.

Behavioral: Promillekoll

PartyPlanner

EXPERIMENTAL

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.

Behavioral: PartyPlanner

Control

NO INTERVENTION

Untreated control group

Interventions

PromillekollBEHAVIORAL

Smartphone app monitoring alcohol use with feedback.

Promillekoll
PartyPlannerBEHAVIORAL

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.

PartyPlanner

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Access to a smartphone running iOS or Android OS.
  • AUDIT \>7 for men or AUDIT \>5 for women.

You may not qualify if:

  • AUDIT \<8 (men) or \<6 (women)
  • No access to a smartphone running iOS or Android OS.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska institutet, Department of Clinical Neuroscience

Stockholm, 17176, Sweden

Location

Related Publications (1)

  • 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.

Study Officials

  • Anne H Berman, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 6, 2013

First Posted

October 9, 2013

Study Start

February 1, 2013

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

April 30, 2019

Record last verified: 2019-04

Locations