NCT02158949

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 3, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 9, 2014

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2014

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2014

Completed
6 years until next milestone

Results Posted

Study results publicly available

July 16, 2020

Completed
Last Updated

July 16, 2020

Status Verified

July 1, 2020

Enrollment Period

3 months

First QC Date

June 3, 2014

Results QC Date

March 23, 2020

Last Update Submit

July 6, 2020

Conditions

Keywords

alcoholmHealthSBIRT

Outcome Measures

Primary Outcomes (1)

  • Acceptability of Intervention to Patient

    percentage of patients that do not opt out of messages prior to 1 week completion

    1 week

Secondary Outcomes (4)

  • Number of Participants Completed Assessment at 1 Month

    1 month

  • Change in Days Drinking Alcohol

    1 month

  • Change in Days Drinking Heavily in 30 Days

    1 month

  • Change in Motivation to Change Score

    1 month

Study Arms (2)

mROAD

EXPERIMENTAL

1 week of twice daily text messages modeled after SBIRT interventions

Behavioral: mROAD

Usual Care

NO INTERVENTION

Usual care in ED

Interventions

mROADBEHAVIORAL
mROAD

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LAC+USC Medicine Center Emergency Department

Los Angeles, California, 90033, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Limitations and Caveats

This is a small pilot trial

Results Point of Contact

Title
Elizabeth Burner
Organization
University of Southern California

Study Officials

  • Elizabeth Burner, MD MPH

    University of Southern California

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Clinical Emergency Medicine

Study Record Dates

First Submitted

June 3, 2014

First Posted

June 9, 2014

Study Start

May 1, 2014

Primary Completion

July 15, 2014

Study Completion

July 31, 2014

Last Updated

July 16, 2020

Results First Posted

July 16, 2020

Record last verified: 2020-07

Locations