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Alcohol AbusemROADNCT02158949

Study of Mobile Phone Delivered Intervention to Reduce Alcohol Consumption

A study testing mROAD in people with Alcohol Abuse, run by University of Southern California at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Alcohol Abuse
What is being tested?
mROAD
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteUnited States
Study dates
1 May 2014to 31 Jul 2014
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • LAC+USC Medicine Center Emergency Department

    Los Angeles, California, 90033

Other trials in United States

About this study

Official title: 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.

Conditions
Alcohol Abuse
Being tested
mROAD
Keywords
alcohol, mHealth, SBIRT
Medical subject headings
Alcoholism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • mROADBehavioural

Study groups in NCT02158949
Study groupRoleWhat they receive
mROADExperimental1 week of twice daily text messages modeled after SBIRT interventions
Receives: Behavioral: mROAD
Usual CareNo interventionUsual care in ED

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Acceptability of Intervention to Patient

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

    Measured: 1 week

Secondary outcomes (4)

  1. 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

    Measured: 1 month

  2. 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

    Measured: 1 month

  3. 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

    Measured: 1 month

  4. 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).

    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.

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2014 (estimated)
  2. Study start1 May 2014
  3. Primary completion15 Jul 2014
  4. Study completion31 Jul 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02158949
Sponsor's protocol ID
HS-14-00335
Acronym
mROAD
Status last verified
Jul 2020
First submitted
3 Jun 2014
Last updated
16 Jul 2020
Data monitoring committee
No

Publications

  • 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.

    PubMed 32496203

Questions about this trial

What is this clinical trial studying?

A study testing mROAD in people with Alcohol Abuse, run by University of Southern California at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Acceptability of Intervention to Patient (time frame: 1 week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02158949, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2020.

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