Study of Mobile Phone Delivered Intervention to Reduce Alcohol Consumption (mROAD)

July 6, 2020 updated by: Elizabeth Burner, University of Southern California

Mobilizing to Reduce Overuse of Alcohol in Emergency Department Patients

In this study, the investigators will be developing and testing a mobile phone text message intervention to reduce alcohol use for people at risk of alcohol dependence. The investigators hypothesize that this intervention will be acceptable to participants, and that they will stay in the intervention until it's one week completion.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90033
        • LAC+USC Medicine Center Emergency Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • AUDIT score 15-20
  • have a mobile phone capable of receiving text messages

Exclusion Criteria:

  • age <18
  • unable to consent
  • language other than English or Spanish

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: mROAD
1 week of twice daily text messages modeled after SBIRT interventions
Behavioral: mROAD
No Intervention: Usual Care
Usual care in ED

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability of Intervention to Patient
Time Frame: 1 week
percentage of patients that do not opt out of messages prior to 1 week completion
1 week

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Completed Assessment at 1 Month
Time Frame: 1 month
Feasibility of follow up of urban low-income at risk drinkers by phone defined as number of patients can be contacted at one months to complete assessment of alcohol use
1 month
Change in Days Drinking Alcohol
Time Frame: 1 month
patients reported number of days drinking any alcohol in prior 30 days, baseline report minus 1 month follow up report
1 month
Change in Days Drinking Heavily in 30 Days
Time Frame: 1 month
patients reported number of heavy drinking days in prior 30 days (3 or more standard sized drinks per episode for women and 4 or more standard sized drinks per episode for men), baseline report minus 1 month follow up report
1 month
Change in Motivation to Change Score
Time Frame: 1 month

Participants reported desire to change via the Change Questionnaire applied to risky alcohol use.[1] The Change questionnaire has a Cronbach's alpha of 0.86 when applied to alcohol use.[2] Minimum score is 0 (low motivation to change) to maximum 120 (high motivation to change).

  1. Miller WR, Johnson WR. A natural language screening measure for motivation to change. Addictive behaviors. 2008;33(9):1177-1182.
  2. Miller WR, Johnson WR. A natural language screening measure for motivation to change. Addictive Behaviors. 2008;33(9):1177-1182.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern California

Investigators

  • Principal Investigator: Elizabeth Burner, MD MPH, University of Southern California

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

July 15, 2014

Study Completion (Actual)

July 31, 2014

Study Registration Dates

First Submitted

June 3, 2014

First Submitted That Met QC Criteria

June 5, 2014

First Posted (Estimate)

June 9, 2014

Study Record Updates

Last Update Posted (Actual)

July 16, 2020

Last Update Submitted That Met QC Criteria

July 6, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS-14-00335

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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