Trial Outcomes & Findings for Study of Mobile Phone Delivered Intervention to Reduce Alcohol Consumption (NCT NCT02158949)

NCT ID: NCT02158949

Last Updated: 2020-07-16

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

48 participants

Primary outcome timeframe

1 week

Results posted on

2020-07-16

Participant Flow

Participant milestones

Participant milestones
Measure	mROAD 1 week of twice daily text messages modeled after SBIRT interventions mROAD	Usual Care Usual care in ED
Overall Study STARTED	24	24
Overall Study COMPLETED	18	13
Overall Study NOT COMPLETED	6	11

Reasons for withdrawal

Reasons for withdrawal
Measure	mROAD 1 week of twice daily text messages modeled after SBIRT interventions mROAD	Usual Care Usual care in ED
Overall Study Withdrawal by Subject	1	0
Overall Study Lost to Follow-up	5	11

Baseline Characteristics

Study of Mobile Phone Delivered Intervention to Reduce Alcohol Consumption

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	mROAD n=24 Participants 1 week of twice daily text messages modeled after SBIRT interventions mROAD	Usual Care n=24 Participants Usual care in ED	Total n=48 Participants Total of all reporting groups
Age, Continuous	38.9 years STANDARD_DEVIATION 13.5 • n=5 Participants	35.4 years STANDARD_DEVIATION 10.6 • n=7 Participants	37.1 years STANDARD_DEVIATION 12.1 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	21 Participants n=7 Participants	40 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	17 Participants n=5 Participants	21 Participants n=7 Participants	38 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants	3 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	6 Participants n=5 Participants	2 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) White	17 Participants n=5 Participants	22 Participants n=7 Participants	39 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	24 participants n=5 Participants	24 participants n=7 Participants	48 participants n=5 Participants
Self report of mental illness	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Days drank alcohol in last month	7.6 days STANDARD_DEVIATION 8.6 • n=5 Participants	11.5 days STANDARD_DEVIATION 8.4 • n=7 Participants	9.6 days STANDARD_DEVIATION 8.6 • n=5 Participants
Days drank heavily in last month	4.9 days STANDARD_DEVIATION 7.2 • n=5 Participants	5.5 days STANDARD_DEVIATION 7.1 • n=7 Participants	5.2 days STANDARD_DEVIATION 7.1 • n=5 Participants
Motivation to change score	88.8 units on a scale STANDARD_DEVIATION 6.7 • n=5 Participants	89.3 units on a scale STANDARD_DEVIATION 33.8 • n=7 Participants	89.1 units on a scale STANDARD_DEVIATION 32.9 • n=5 Participants

PRIMARY outcome

Timeframe: 1 week

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

Outcome measures

Outcome measures
Measure	mROAD n=24 Participants 1 week of twice daily text messages modeled after SBIRT interventions mROAD	Usual Care n=24 Participants Usual care in ED
Acceptability of Intervention to Patient	23 Participants	24 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	mROAD n=24 Participants 1 week of twice daily text messages modeled after SBIRT interventions mROAD	Usual Care n=24 Participants Usual care in ED
Number of Participants Completed Assessment at 1 Month	18 Participants	13 Participants

SECONDARY outcome

Timeframe: 1 month

patients reported number of days drinking any alcohol in prior 30 days, baseline report minus 1 month follow up report

Outcome measures

Outcome measures
Measure	mROAD n=18 Participants 1 week of twice daily text messages modeled after SBIRT interventions mROAD	Usual Care n=13 Participants Usual care in ED
Change in Days Drinking Alcohol	2.5 days Interval -1.7 to 6.7	8.5 days Interval 3.0 to 13.9

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	mROAD n=18 Participants 1 week of twice daily text messages modeled after SBIRT interventions mROAD	Usual Care n=13 Participants Usual care in ED
Change in Days Drinking Heavily in 30 Days	3 days Interval -0.7 to 6.7	5.6 days Interval -0.1 to 11.4

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	mROAD n=18 Participants 1 week of twice daily text messages modeled after SBIRT interventions mROAD	Usual Care n=13 Participants Usual care in ED
Change in Motivation to Change Score	7.6 score on a scale Interval -1.7 to 17.0	16.6 score on a scale Interval -1.6 to 34.0

Adverse Events

mROAD

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Elizabeth Burner

University of Southern California

Phone: 3234096667

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place