Trial document




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  DRKS00014274

Trial Description

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Title

Testing a proactive expert system intervention to prevent and to quit at-risk alcohol use

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Trial Acronym

PRINT

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The aim of the PRINT study is to test the efficacy of a brief alcohol intervention using a general population sample (registry office clients). Adults between 18 and 64 years with past year alcohol use are randomly allocated to an intervention group receiving computer-generated individualized feedback letters or an “assessment only” control group. Participants complete four assessments: the baseline assessment, two aftercare assessments at months 3 and 6, and one follow-up assessment at month 12.

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Brief Summary in Scientific Language

The PRINT study is a two-arm randomized controlled trial to test the efficacy of a brief alcohol intervention using an adult general population sample. During opening hours, all 18- to 64-year-old registry office clients appearing in the waiting area are approached by study assistants and asked to respond to questions about health risk behaviors. Persons who report alcohol use in the previous twelve months are eligible and asked to participate in the trial. Participants are assigned by tablet PC using a random generator to either the intervention group or the control group (allocation ratio 1:1). Participants in the intervention group receive computer-generated individualized feedback letters and self-help manuals at baseline, month 3, and month 6. Participants in the control group receive minimal assessment only. Twelve-month follow-up assessments are conducted via computer-assisted telephone interviews.

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Organizational Data

  •   DRKS00014274
  •   2018/03/12
  •   [---]*
  •   yes
  •   Approved
  •   BB 147/15, Ethikkommission an der Medizinischen Fakultät der Ernst-Moritz-Arndt-Universität Greifswald
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Secondary IDs

  •   BA 5858/2-1  (DFG-Förderkennzeichen)
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Health Condition or Problem studied

  •   alcohol use
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Interventions/Observational Groups

  •   Intervention group: Participants in the intervention group receive individualized feedback letters and self-help manuals (if appropriate) at baseline, month 3, and month 6. An expert system software (i) analyzes data on alcohol use and motivational constructs in comparison to general population data, (ii) selects supportive text modules and graphics, and (iii) automatically generates feedback letters. The feedback is matched to the motivational stage of change and alcohol use problem severity.
  •   Control group (assessment only): Participants in the control group receive minimal assessment at baseline, month 3, and month 6, including alcohol use, motivation to change, socio-demographics, and health-related variables.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   assessor
  •   Control group receives no treatment
  •   Prevention
  •   Parallel
  •   II
  •   N/A
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Primary Outcome

Number of drinks containing alcohol per day (change from baseline to month 12): Quantity-frequency product determined by two questions concerning alcohol use in the month prior to assessment: (1) “In the past 30 days, how often did you have an alcoholic drink?” (never/ once/ 2-4 times/ 2-3 times per week/ 4 or more times per week) and (2) “In the past 30 days, how many drinks did you typically have on a drinking day?”. A drink is defined as 0.25-0.3 l beer, 0.1-0.15 l wine/ sparkling wine, or 4 cl spirits.

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Secondary Outcome

a) at-risk alcohol use (change from baseline to month 12): Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) score of 4/ 5 or more for women/ men,
b) number of heavy drinking days in the past week (change from baseline to month 12) determined by asking “How many drinks did you have on each single day during the past seven days, starting with yesterday?” and summing the days with 4/ 5 or more drinks for women/ men,
c) alcohol use problem severity (change from baseline to month 12): AUDIT score,
d) motivation to change (change from baseline to month 12): 4-item staging algorithm,
e) tobacco use (change from baseline to month 12): quantity-frequency index based on two questions: (1) "On how many days per month did you smoke cigarettes/ cigarillos/ cigars/ pipes?" and (2) "How many cigarettes/ cigarillos/ cigars/ pipes did you typically smoke on a smoking day?".
f) mental health (change from baseline to month 12): 5-item mental health inventory (MHI-5),
g) self-reported health (change from baseline to month 12): “Would you say your health in general is: excellent/ very good/ good/ fair/ poor?”

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2018/04/10
  •   1648
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   64   Years
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Additional Inclusion Criteria

alcohol use in the previous twelve months

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Exclusion Criteria

a) cognitively or physically incapable, b) insufficient language or reading skills, c) already approached during an earlier visit, d) escorting person, e) employed at the conducting research Institute, f) no telephone, g) no address

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Addresses

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    • Universitätsmedizin GreifswaldKörperschaft des öffentlichen Rechts
    • Fleischmannstr. 8
    • 17475  Greifswald
    • Germany
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    •   [---]*
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    • Technische Universität Dresden, Medizinische Fakultät, Institut und Poliklinik für Arbeits- und Sozialmedizin
    • Ms.  Jun.-Prof.  Sophie  Baumann 
    • Fetscherstr. 74
    • 01307  Dresden
    • Germany
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    • Universitätsmedizin Greifswald, Institut für Sozialmedizin und Prävention
    • Mr.  M.Sc. Psych.  Andreas  Staudt 
    • Walther-Rathenau-Str. 48
    • 17475  Greifswald
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2019/07/31
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Trial Publications, Results and other Documents

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