Trial Outcomes & Findings for Evaluation of an Internet-based Intervention for Hazardous Drinkers (NCT NCT01075685)

Results Overview

The unit of "standard drink" is a drink containing 10g of pure alcohol. Participants had to report their weekly alcohol intake in a diary, in which they could choose among 21 glasses of various capacities and containing various alcoholic drinks. Each of those glasses was then converted into standard drinks.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

1157 participants

Primary outcome timeframe

baseline and 6 weeks

Results posted on

2010-11-10

Participant Flow

Recruitment period: Oct 27 to Dec 15, 2009 Recruitment was conducted via Internet.

Participant milestones

Participant milestones
Measure	Web-based Alcohol Programme	Minimum Information
Overall Study STARTED	743	414
Overall Study Met Inclusion Criteria	734	413
Overall Study Completed Baseline Measures	225	263
Overall Study COMPLETED	151	188
Overall Study NOT COMPLETED	592	226

Reasons for withdrawal

Reasons for withdrawal
Measure	Web-based Alcohol Programme	Minimum Information
Overall Study Protocol Violation	9	1
Overall Study Withdrawal by Subject	20	5
Overall Study Lost to Follow-up	563	220

Baseline Characteristics

Evaluation of an Internet-based Intervention for Hazardous Drinkers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Web-based Alcohol Programme n=734 Participants	Minimum Information n=413 Participants	Total n=1147 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	718 Participants n=5 Participants	408 Participants n=7 Participants	1126 Participants n=5 Participants
Age, Categorical >=65 years	16 Participants n=5 Participants	5 Participants n=7 Participants	21 Participants n=5 Participants
Sex: Female, Male Female	232 Participants n=5 Participants	130 Participants n=7 Participants	362 Participants n=5 Participants
Sex: Female, Male Male	502 Participants n=5 Participants	283 Participants n=7 Participants	785 Participants n=5 Participants
AUDIT score	8.7 Units on a scale STANDARD_DEVIATION 1.9 • n=5 Participants	8.8 Units on a scale STANDARD_DEVIATION 1.8 • n=7 Participants	8.7 Units on a scale STANDARD_DEVIATION 1.8 • n=5 Participants
Weekly alcohol intake at baseline	17.5 standard drinks STANDARD_DEVIATION 13.3 • n=5 Participants	16.2 standard drinks STANDARD_DEVIATION 13.2 • n=7 Participants	16.8 standard drinks STANDARD_DEVIATION 13.3 • n=5 Participants

PRIMARY outcome

Timeframe: baseline and 6 weeks

Population: Only participants who completed the study were included in this analysis

The unit of "standard drink" is a drink containing 10g of pure alcohol. Participants had to report their weekly alcohol intake in a diary, in which they could choose among 21 glasses of various capacities and containing various alcoholic drinks. Each of those glasses was then converted into standard drinks.

Outcome measures

Outcome measures
Measure	Web-based Alcohol Programme n=151 Participants	Minimum Information n=188 Participants
Change in Weekly Alcohol Intake	-3.34 standard drinks Standard Deviation 12.19	-1.21 standard drinks Standard Deviation 10.86

SECONDARY outcome

Timeframe: baseline and 6 weeks

Population: Participants with weekly alcohol consumption baseline at 0 were excluded from this analysis

(6 weeks minus baseline)/baseline

Outcome measures

Outcome measures
Measure	Web-based Alcohol Programme n=148 Participants	Minimum Information n=176 Participants
Relative Change in Weekly Alcohol Intake	-0.51 percent of baseline consumption Standard Deviation 97.58 • Interval -100.0 to 507.14	11.22 percent of baseline consumption Standard Deviation 99.89 • Interval -100.0 to 692.0

SECONDARY outcome

Timeframe: baseline and 6 weeks

Category of change in weekly alcohol intake (WAI) is a 3-level categorical variable whose values are: * clinically significant reduction in WAI, defined as a decrease of 10% or over; * clinically significant increase in WAI, defined as an increase of 10% or over if WAI at baseline is positive, or any increase if WAI at baseline is 0); * and no clinically significant change, which includes all other cases.

Outcome measures

Outcome measures
Measure	Web-based Alcohol Programme n=151 Participants	Minimum Information n=188 Participants
Category of Change in Weekly Alcohol Intake significant reduction in weekly alcohol intake	93 participants	87 participants
Category of Change in Weekly Alcohol Intake no significant change in weekly alcohol intake	7 participants	13 participants
Category of Change in Weekly Alcohol Intake significant increase in weekly alcohol intake	42 participants	63 participants

SECONDARY outcome

Timeframe: baseline and 6 weeks

The number of excessive drinkers is the number of participants whose weekly alcohol intake exceeds guidelines, i.e. 21 or 14 standard drinks (male/female) per week

Outcome measures

Outcome measures
Measure	Web-based Alcohol Programme n=151 Participants	Minimum Information n=188 Participants
Change in the Number of Excessive Drinkers	-11 participants	-5 participants

Adverse Events

Web-based Alcohol Programme

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Minimum Information

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

Juliette Guillemont

Inpes

Phone: +331 49 33 22 55

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place