Testing a proactive expert system intervention to prevent and to quit at-risk alcohol use
Organizational Data
- DRKS-ID:
- DRKS00014274
- Recruitment Status:
- Recruiting complete, study complete
- Date of registration in DRKS:
- 2018-03-12
- Last update in DRKS:
- 2020-04-30
- Registration type:
- Prospective
Acronym/abbreviation of the study
URL of the study
No Entry
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.
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.
Health condition or problem studied
- Free text:
- alcohol use
- Healthy volunteers:
- No Entry
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.
Endpoints
- 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.
- 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?”
Study Design
- Purpose:
- Prevention
- Allocation:
- Randomized controlled study
- Control:
-
- Control group receives no treatment
- Phase:
- II
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- Yes
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
-
- Assessor
Recruitment
- Recruitment Status:
- Recruiting complete, study complete
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- Other Amt für Bürgerservice/ registry office Greifswald
Recruitment period and number of participants
- Planned study start date:
- 2018-04-10
- Actual study start date:
- 2018-04-10
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- 2019-07-31
- Target Sample Size:
- 1648
- Final Sample Size:
- 1646
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- 64 Years
- Additional Inclusion Criteria:
- alcohol use in the previous twelve months
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
Addresses
Primary Sponsor
- Address:
- Universitätsmedizin GreifswaldKörperschaft des öffentlichen RechtsFleischmannstr. 817475 GreifswaldGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Technische Universität Dresden, Medizinische Fakultät, Institut und Poliklinik für Arbeits- und SozialmedizinJun.-Prof. Sophie BaumannFetscherstr. 7401307 DresdenGermany
- Telephone:
- +49 351 3177-447
- Fax:
- +49 351 3177-459
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://tu-dresden.de/med/mf/ipas
Contact for Public Queries
- Address:
- TU Dresden, Medizinische Fakultät, Institut und Poliklinik für Arbeits- und SozialmedizinM.Sc. Psych. Andreas StaudtFetscherstraße 7401307 DresdenGermany
- Telephone:
- +493513177452
- Fax:
- +493513177459
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://tu-dresden.de/med/mf/ipas
Principal Investigator
- Address:
- Technische Universität Dresden, Medizinische Fakultät, Institut und Poliklinik für Arbeits- und SozialmedizinJun.-Prof. Sophie BaumannFetscherstr. 7401307 DresdenGermany
- Telephone:
- +49 351 3177-447
- Fax:
- +49 351 3177-459
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://tu-dresden.de/med/mf/ipas
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.)
- Address:
- Deutsche ForschungsgemeinschaftKennedyallee 4053175 BonnGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.dfg.de
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission an der Universitätsmedizin Greifswald, Institut für PharmakologieFelix-Hausdorff-Straße 317487 GreifswaldGermany
- Telephone:
- +49-3834-865644
- Fax:
- +49-3834-865631
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2015-10-20
- Ethics committee number:
- BB 147/15
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2015-10-28
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
- Other secondary IDs:
- BA 5858/2-1 - DFG-Förderkennzeichen
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No Entry
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study 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.
- 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.
- 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.
- 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.
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- 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.
- 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.
- 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.
- 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]
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry