Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-28 @ 1:04 AM
Study NCT ID:
NCT01291693
Status:
COMPLETED
Last Update Posted:
2015-12-03
First Post:
2011-02-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Testing Delivery Channels of Brief Motivational Alcohol Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 975}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-01', 'studyFirstSubmitDate': '2011-02-04', 'studyFirstSubmitQcDate': '2011-02-07', 'lastUpdatePostDateStruct': {'date': '2015-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-02-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Risky drinking', 'timeFrame': '6, 12, 18, 24 months', 'description': 'Determined by using average alcohol consumption per day, heavy occasional drinking, highest blood alcohol concentration, the Alcohol Use Disorder Identification Test-Consumption (AUDIT-C) score'}], 'secondaryOutcomes': [{'measure': 'Motivation to reduce drinking', 'timeFrame': '6, 12, 18, 24 months', 'description': 'Assessed by a stages of change-algorithm'}, {'measure': 'Attempts to reduce drinking', 'timeFrame': '6, 12, 18, 24 months'}, {'measure': 'Knowledge about drinking limits', 'timeFrame': '6, 12, 18, 24 months'}, {'measure': 'Self-efficacy scores', 'timeFrame': '6 months', 'description': 'Assessed by a modified short-form of the Alcohol-Abstinence-Self-Efficacy-Scale (AASE). The modified form assesses self-efficacy regarding compliance with drinking limits.'}, {'measure': 'Decisional balance scores', 'timeFrame': '6 months', 'description': 'Assessed by a short form of the Alcohol Decisional Balance Scale (ADBS)'}, {'measure': 'Self-rated health', 'timeFrame': '6, 12, 18, 24 months'}, {'measure': 'Health care utilization', 'timeFrame': '6, 12, 18, 24 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hazardous drinking', 'general hospital', 'brief intervention', 'Motivational Interviewing', 'computer-generated feedback', 'stage-tailored', 'delivery channel'], 'conditions': ['Hazardous Drinking']}, 'referencesModule': {'references': [{'pmid': '37957757', 'type': 'DERIVED', 'citation': 'Krolo-Wicovsky F, Baumann S, Tiede A, Bischof G, John U, Gaertner B, Freyer-Adam J. Do in-person and computer-based brief alcohol interventions reduce tobacco smoking among general hospital patients? Secondary outcomes from a randomized controlled trial. Addict Sci Clin Pract. 2023 Nov 13;18(1):68. doi: 10.1186/s13722-023-00425-7.'}, {'pmid': '35089156', 'type': 'DERIVED', 'citation': 'Freyer-Adam J, Baumann S, Bischof G, Staudt A, Goeze C, Gaertner B, John U. Social Equity in the Efficacy of Computer-Based and In-Person Brief Alcohol Interventions Among General Hospital Patients With At-Risk Alcohol Use: A Randomized Controlled Trial. JMIR Ment Health. 2022 Jan 28;9(1):e31712. doi: 10.2196/31712.'}, {'pmid': '31783832', 'type': 'DERIVED', 'citation': 'Freyer-Adam J, Noetzel F, Baumann S, Aghdassi AA, Siewert-Markus U, Gaertner B, John U. Behavioral health risk factor profiles in general hospital patients: identifying the need for screening and brief intervention. BMC Public Health. 2019 Nov 29;19(1):1594. doi: 10.1186/s12889-019-7931-6.'}, {'pmid': '28967769', 'type': 'DERIVED', 'citation': 'Freyer-Adam J, Baumann S, Haberecht K, Tobschall S, Bischof G, John U, Gaertner B. In-person alcohol counseling versus computer-generated feedback: Results from a randomized controlled trial. Health Psychol. 2018 Jan;37(1):70-80. doi: 10.1037/hea0000556. Epub 2017 Oct 2.'}, {'pmid': '28333511', 'type': 'DERIVED', 'citation': 'Baumann S, Gaertner B, Haberecht K, Meyer C, Rumpf HJ, John U, Freyer-Adam J. Does impaired mental health interfere with the outcome of brief alcohol intervention at general hospitals? J Consult Clin Psychol. 2017 Jun;85(6):562-573. doi: 10.1037/ccp0000201. Epub 2017 Mar 23.'}], 'seeAlsoLinks': [{'url': 'http://www2.medizin.uni-greifswald.de/prevention/1/', 'label': 'Homepage Institute of Social Medicine and Prevention, University Medicine Greifswald'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate whether motivation-tailored alcohol interventions are more effective when delivered by person or by computer-generated feedback letters. A sample of 920 general hospital inpatients with risky drinking will be recruited through a computerized screening procedure. Patients with more severe alcohol problems will be excluded from the study. Participants will be allocated by time frame randomization to one of three study arms: (1) personal counseling based on Motivational Interviewing, (2) computer-expert system intervention that generates individualized feedback-letters, and (3) control group (treatment-as-usual). The interventions differ in their channel of delivery, but not regarding their content. Both intervention groups receive interventions at three time points: directly after the baseline-assessment at the general hospital, and 1 and 3 months later by mail and phone, respectively. Outcome will be assessed six, 12, 18 and 24 months after baseline.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* General hospital inpatients with risky drinking (AUDIT-C \\>= 4/5 (women/men) and AUDIT \\< 20)\n\nExclusion Criteria:\n\n* Patients already recruited during an earlier hospital stay\n* Patients physically and mentally not capable of participating in the study\n* Patients with a hospital stay of less than 24 hours\n* Patients with insufficient language/ reading skills\n* Patients employed at one of the departments participating in the study or conducting the study\n* Patients with more severe alcohol problems (AUDIT \\>= 20)'}, 'identificationModule': {'nctId': 'NCT01291693', 'acronym': 'PECO', 'briefTitle': 'Testing Delivery Channels of Brief Motivational Alcohol Intervention', 'organization': {'class': 'OTHER', 'fullName': 'University Medicine Greifswald'}, 'officialTitle': 'Testing Delivery Channels of Brief Motivational Alcohol Intervention Among General Hospital Inpatients With Risky Drinking: Personal Counseling Versus Computer-generated Feedback Letters', 'orgStudyIdInfo': {'id': '108376'}, 'secondaryIdInfos': [{'id': 'DM8-IESO03', 'type': 'REGISTRY', 'domain': 'University Medicine Greifswald'}, {'id': '108376', 'type': 'OTHER_GRANT', 'domain': 'German Cancer Aid'}, {'id': 'DM8-IESO04', 'type': 'REGISTRY', 'domain': 'University Medicine Greifswald'}, {'id': '109737', 'type': 'OTHER_GRANT', 'domain': 'German Cancer Aid'}, {'id': '110676', 'type': 'OTHER_GRANT', 'domain': 'German Cancer Aid'}, {'id': '110543', 'type': 'OTHER_GRANT', 'domain': 'German Cancer Aid'}, {'id': '111346', 'type': 'OTHER_GRANT', 'domain': 'German Cancer Aid'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Personal counseling', 'interventionNames': ['Behavioral: Personal Counseling']}, {'type': 'EXPERIMENTAL', 'label': 'Computer generated feedback letters', 'interventionNames': ['Behavioral: Computer-generated feedback letters']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Treatment as usual'}], 'interventions': [{'name': 'Personal Counseling', 'type': 'BEHAVIORAL', 'description': 'At three time-points, participants receive counseling by health professionals trained in Motivational Interviewing based counseling. To assure that both interventions do not differ in their content, individual manuals generated by a software program are used. Counseling will be face-to-face during the hospital stay, and by phone one and three months later.', 'armGroupLabels': ['Personal counseling']}, {'name': 'Computer-generated feedback letters', 'type': 'BEHAVIORAL', 'description': 'At three time points, participants receive feedback letters, tailored to the stages of change according to the TTM, and generated by a computer software program. The first letter is handed out during their hospital stay and includes normative feedback. One and three months later, participants receive ipsative feedback letters by mail.', 'armGroupLabels': ['Computer generated feedback letters']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17475', 'city': 'Greifswald', 'state': 'Mecklenburg-Vorpommern', 'country': 'Germany', 'facility': 'Institute of Social Medicine and Prevention, University Medicine Greifswald', 'geoPoint': {'lat': 54.08905, 'lon': 13.40244}}], 'overallOfficials': [{'name': 'Jennis Freyer-Adam, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute of Social Medicine and Prevention, University Medicine Greifswald'}, {'name': 'Beate Gaertner, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Epidemiology and Health Monitoring, Robert Koch-Institute Berlin'}, {'name': 'Ulrich John, Prof PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute of Social Medicine and Prevention, University Medicine Greifswald'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Medicine Greifswald', 'class': 'OTHER'}, 'collaborators': [{'name': 'German Cancer Aid', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle investigator', 'investigatorFullName': 'Dr. Jennis Freyer-Adam', 'investigatorAffiliation': 'University Medicine Greifswald'}}}}