Trial document

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DRKS-ID: 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

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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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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

DRKS-ID: DRKS00014274
Date of Registration in DRKS: 2018/03/12
Date of Registration in Partner Registry or other Primary Registry: [---]*
Investigator Sponsored/Initiated Trial (IST/IIT): yes
Ethics Approval/Approval of the Ethics Committee: Approved
(leading) Ethics Committee No.: BB 147/15, Ethikkommission an der Medizinischen Fakultät der Ernst-Moritz-Arndt-Universität Greifswald

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Secondary IDs

Other Secondary-ID: BA 5858/2-1 (DFG-Förderkennzeichen)

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Health Condition or Problem studied

Free text: alcohol use

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Interventions/Observational Groups

Arm 1: 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.
Arm 2: 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

Study Type: Interventional
Study Type Non-Interventional: [---]*
Allocation: Randomized controlled trial
Blinding: Blinded
Who is blinded: assessor
Control: Control group receives no treatment
Purpose: Prevention
Assignment: Parallel
Phase: II
Off-label Drug use: 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

DE: Germany

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Locations of Recruitment

other Amt für Bürgerservice/ registry office, Greifswald

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Recruitment

Planned/Actual: Actual
(Anticipated or Actual) Date of First Enrollment: 2018/04/10
Target Sample Size: 1648
Monocenter/Multicenter trial: Monocenter trial
National/International: National

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Inclusion Criteria

Gender: Both, male and female
Minimum Age: 18 Years
Maximum Age: 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

Primary Sponsor
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- Universitätsmedizin GreifswaldKörperschaft des öffentlichen Rechts
- Fleischmannstr. 8
- 17475 Greifswald
- Germany
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: [---]*
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Contact for Scientific Queries
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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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- Telephone: +49 351 3177-447
- Fax: +49 351 3177-459
- E-mail: sophie.baumann at tu-dresden.de
- URL: https://tu-dresden.de/med/mf/ipas
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Contact for Public Queries
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- TU Dresden, Medizinische Fakultät, Institut und Poliklinik für Arbeits- und Sozialmedizin
- Mr. M.Sc. Psych. Andreas Staudt
- Fetscherstraße 74
- 01307 Dresden
- Germany
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- Telephone: +493513177452
- Fax: +493513177459
- E-mail: andreas.staudt at tu-dresden.de
- URL: https://tu-dresden.de/med/mf/ipas
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Sources of Monetary or Material Support

Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
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- Deutsche Forschungsgemeinschaft
- Kennedyallee 40
- 53175 Bonn
- Germany
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- Telephone: [---]*
- Fax: [---]*
- E-mail: [---]*
- URL: http://www.dfg.de
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Status

Recruitment Status: Recruiting complete, follow-up complete
Study Closing (LPLV): 2019/07/31

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Trial Publications, Results and other Documents

Paper: Baumann S, Staudt A, Freyer-Adam J, John U. A proactive expert system intervention to prevent or quit at-risk alcohol use (PRINT): study protocol of a randomized controlled trial. BMC Public Health, 18:851, 2018.
Paper: Staudt A, Freyer-Adam J, Meyer C, John U, Baumann S. Short-term stability of different drinking patterns over the course of four weeks among adults. A latent transition analysis. Drug Alcohol Depend, 191, 181-6, 2018.
Abstract: Baumann S, Staudt A, Freyer-Adam J, John U. Überprüfung der Wirksamkeit einer proaktiven Intervention zur Prävention von gesundheitsriskantem Alkoholkonsum: Studiendesign und Teilnahme. Gesundheitswesen, 80(08/09), 778, 2018.
Abstract: Staudt A, Freyer-Adam J, John U, Baumann S. Randomized controlled trial of a proactive expert system intervention to prevent at-risk alcohol use: study protocol and reach. Eur J Publ Health, 28(S4), 421, 2018.
Abstract: Staudt A, Freyer-Adam J, Meyer C, John U, Baumann S. Wie verändern sich Trinkmuster über vier Wochen? Eine latent transition analysis. Gesundheitswesen, 80(08/09), 806, 2018.
Abstract: Staudt A, Ulbricht S, Freyer-Adam J, Meyer C, John U, Baumann S. Gesundheitsbezogene Verhaltensprofile und Wiedererreichung in einer 4-Wochen-Längsschnittstudie. Gesundheitswesen, 80(08/09), 795, 2018.
Paper: Staudt A, Freyer-Adam J, Bischof G, Meyer C, John U, Baumann S. Does prior recall of past week alcohol use affect screening result for at-risk drinking? Findings from a randomized study. PLoS ONE, 14(6): e0217595, 2019.
Paper: Staudt A, Freyer-Adam J, John U, Meyer C, Baumann S. Stability of at-risk alcohol use screening in a general population sample. Alcohol Clin Exp Res, 2020. doi: 10.1111/acer.14340 [Epub ahead of print]

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