Testing Delivery Channels of Brief Motivational Alcohol Intervention (PECO)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
German Cancer Aid
Information provided by (Responsible Party):
Dr. Jennis Freyer-Adam, University Medicine Greifswald
ClinicalTrials.gov Identifier:
NCT01291693
First received: February 4, 2011
Last updated: June 6, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Hazardous Drinking
Behavioral: Personal Counseling
Behavioral: Computer-generated feedback letters
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Testing Delivery Channels of Brief Motivational Alcohol Intervention Among General Hospital Inpatients With Risky Drinking: Personal Counseling Versus Computer-generated Feedback Letters

Further study details as provided by University Medicine Greifswald:

Primary Outcome Measures:
  • Risky drinking [ Time Frame: 6, 12, 18, 24 months ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Motivation to reduce drinking [ Time Frame: 6, 12, 18, 24 months ] [ Designated as safety issue: No ]
    Assessed by a stages of change-algorithm

  • Attempts to reduce drinking [ Time Frame: 6, 12, 18, 24 months ] [ Designated as safety issue: No ]
  • Knowledge about drinking limits [ Time Frame: 6, 12, 18, 24 months ] [ Designated as safety issue: No ]
  • Self-efficacy scores [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.

  • Decisional balance scores [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Assessed by a short form of the Alcohol Decisional Balance Scale (ADBS)

  • Self-rated health [ Time Frame: 6, 12, 18, 24 months ] [ Designated as safety issue: No ]
  • Health care utilization [ Time Frame: 6, 12, 18, 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 920
Study Start Date: February 2011
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Personal counseling Behavioral: Personal Counseling
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.
Experimental: Computer generated feedback letters Behavioral: Computer-generated feedback letters
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.
No Intervention: Control group
Treatment as usual

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • General hospital inpatients with risky drinking (AUDIT-C >= 4/5 (women/men) and AUDIT < 20)

Exclusion Criteria:

  • Patients already recruited during an earlier hospital stay
  • Patients physically and mentally not capable of participating in the study
  • Patients with a hospital stay of less than 24 hours
  • Patients with insufficient language/ reading skills
  • Patients employed at one of the departments participating in the study or conducting the study
  • Patients with more severe alcohol problems (AUDIT >= 20)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01291693

Locations
Germany
Institute of Epidemiology and Social Medicine, University Medicine Greifswald
Greifswald, Mecklenburg-Western Pomerania, Germany, 17475
Sponsors and Collaborators
University Medicine Greifswald
German Cancer Aid
Investigators
Principal Investigator: Jennis Freyer-Adam, PhD Institute of Epidemiology and Social Medicine, University Medicine Greifswald
Principal Investigator: Beate Gaertner, PhD Institute of Biometry and Clinical Epidemiology, Charité University Medicine Berlin
Principal Investigator: Ulrich John, Prof PhD Institute of Epidemiology and Social Medicine, University Medicine Greifswald
  More Information

Additional Information:
No publications provided

Responsible Party: Dr. Jennis Freyer-Adam, Principle investigator, University Medicine Greifswald
ClinicalTrials.gov Identifier: NCT01291693     History of Changes
Other Study ID Numbers: 108376, DM8-IESO03, 108376, DM8-IESO04, 109737, 110676, 110543
Study First Received: February 4, 2011
Last Updated: June 6, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by University Medicine Greifswald:
Hazardous drinking
general hospital
brief intervention
Motivational Interviewing
computer-generated feedback
stage-tailored
delivery channel

ClinicalTrials.gov processed this record on July 20, 2014