Study of Mobile Phone Delivered Intervention to Reduce Alcohol Consumption (mROAD)
Primary Purpose
Alcohol Abuse
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
mROAD
Sponsored by
About this trial
This is an interventional treatment trial for Alcohol Abuse focused on measuring alcohol, mHealth, SBIRT
Eligibility Criteria
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
Sites / Locations
- LAC+USC Medicine Center Emergency Department
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
mROAD
Usual Care
Arm Description
1 week of twice daily text messages modeled after SBIRT interventions
Usual care in ED
Outcomes
Primary Outcome Measures
Acceptability of Intervention to Patient
percentage of patients that do not opt out of messages prior to 1 week completion
Secondary Outcome Measures
Number of Participants Completed Assessment at 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
Change in Days Drinking Alcohol
patients reported number of days drinking any alcohol in prior 30 days, baseline report minus 1 month follow up report
Change in Days Drinking Heavily in 30 Days
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
Change in Motivation to Change Score
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).
Miller WR, Johnson WR. A natural language screening measure for motivation to change. Addictive behaviors. 2008;33(9):1177-1182.
Miller WR, Johnson WR. A natural language screening measure for motivation to change. Addictive Behaviors. 2008;33(9):1177-1182.
Full Information
NCT ID
NCT02158949
First Posted
June 3, 2014
Last Updated
July 6, 2020
Sponsor
University of Southern California
1. Study Identification
Unique Protocol Identification Number
NCT02158949
Brief Title
Study of Mobile Phone Delivered Intervention to Reduce Alcohol Consumption
Acronym
mROAD
Official Title
Mobilizing to Reduce Overuse of Alcohol in Emergency Department Patients
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
May 1, 2014 (undefined)
Primary Completion Date
July 15, 2014 (Actual)
Study Completion Date
July 31, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Abuse
Keywords
alcohol, mHealth, SBIRT
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
mROAD
Arm Type
Experimental
Arm Description
1 week of twice daily text messages modeled after SBIRT interventions
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Usual care in ED
Intervention Type
Behavioral
Intervention Name(s)
mROAD
Primary Outcome Measure Information:
Title
Acceptability of Intervention to Patient
Description
percentage of patients that do not opt out of messages prior to 1 week completion
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Number of Participants Completed Assessment at 1 Month
Description
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
Time Frame
1 month
Title
Change in Days Drinking Alcohol
Description
patients reported number of days drinking any alcohol in prior 30 days, baseline report minus 1 month follow up report
Time Frame
1 month
Title
Change in Days Drinking Heavily in 30 Days
Description
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
Time Frame
1 month
Title
Change in Motivation to Change Score
Description
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).
Miller WR, Johnson WR. A natural language screening measure for motivation to change. Addictive behaviors. 2008;33(9):1177-1182.
Miller WR, Johnson WR. A natural language screening measure for motivation to change. Addictive Behaviors. 2008;33(9):1177-1182.
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Burner, MD MPH
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
LAC+USC Medicine Center Emergency Department
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
32496203
Citation
Burner E, Zhang M, Terp S, Ford Bench K, Lee J, Lam CN, Torres JR, Menchine M, Arora S. Feasibility and Acceptability of a Text Message-Based Intervention to Reduce Overuse of Alcohol in Emergency Department Patients: Controlled Proof-of-Concept Trial. JMIR Mhealth Uhealth. 2020 Jun 4;8(6):e17557. doi: 10.2196/17557.
Results Reference
derived
Learn more about this trial
Study of Mobile Phone Delivered Intervention to Reduce Alcohol Consumption
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