Trial Outcomes & Findings for Telephone Disease Management At-Risk Drinking (TDM II) (NCT NCT00123409)
NCT ID: NCT00123409
Last Updated: 2015-04-24
Results Overview
Alcohol use as measured by the number of drinking days. Lower is better. There are no upper limits. The lower limit is 0.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
146 participants
Primary outcome timeframe
12 months
Results posted on
2015-04-24
Participant Flow
Participant milestones
| Measure |
Arm 1
Telephone Based care management for reducing alcohol use
Telephone disease management: Telephone based care management
|
Arm 2
Usual Care
Usual Care: Usual care
|
|---|---|---|
|
Overall Study
STARTED
|
72
|
74
|
|
Overall Study
COMPLETED
|
68
|
71
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Telephone Disease Management At-Risk Drinking (TDM II)
Baseline characteristics by cohort
| Measure |
Telephone Disease Management
n=68 Participants
Telephone Based care management for reducing alcohol use
Telephone disease management: Telephone based care management
|
Usual Care
n=71 Participants
Usual Care
Usual Care: Usual care
|
Total
n=139 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.3 years
STANDARD_DEVIATION 15.1 • n=99 Participants
|
57 years
STANDARD_DEVIATION 13.9 • n=107 Participants
|
57.1 years
STANDARD_DEVIATION 14 • n=206 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
67 Participants
n=99 Participants
|
69 Participants
n=107 Participants
|
136 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
30 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
63 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
38 Participants
n=99 Participants
|
38 Participants
n=107 Participants
|
76 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
68 participants
n=99 Participants
|
71 participants
n=107 Participants
|
139 participants
n=206 Participants
|
|
# of Days Drinking in last 28 days
|
19.53 # of days drinking
STANDARD_DEVIATION 9.44 • n=99 Participants
|
20.2 # of days drinking
STANDARD_DEVIATION 8.12 • n=107 Participants
|
19.9 # of days drinking
STANDARD_DEVIATION 8.8 • n=206 Participants
|
|
Problems related to alcohol
|
4.31 # problems
STANDARD_DEVIATION 5.52 • n=99 Participants
|
4.7 # problems
STANDARD_DEVIATION 5.52 • n=107 Participants
|
4.5 # problems
STANDARD_DEVIATION 5.52 • n=206 Participants
|
PRIMARY outcome
Timeframe: 12 monthsAlcohol use as measured by the number of drinking days. Lower is better. There are no upper limits. The lower limit is 0.
Outcome measures
| Measure |
Telephone Based Management
n=68 Participants
Telephone Based Management used to reduce alcohol misuse
Telephone disease management: Telephone based care management
|
Usual Care
n=71 Participants
Usual Care
Usual Care: Usual care
|
|---|---|---|
|
Reduced Alcohol Use
|
14.96 Days drinking
Standard Deviation 12.55
|
15.52 Days drinking
Standard Deviation 10.12
|
SECONDARY outcome
Timeframe: 12 monthsThe Short Inventory of Problmes was used to measure the number of alcohol related problems encountered in the prior 3 months. The scale has a minimum of 0 with lower as better. The max score is 15 with each problem rated as present or absent.
Outcome measures
| Measure |
Telephone Based Management
n=68 Participants
Telephone Based Management used to reduce alcohol misuse
Telephone disease management: Telephone based care management
|
Usual Care
n=71 Participants
Usual Care
Usual Care: Usual care
|
|---|---|---|
|
Reduced Problems Related to Alcohol
|
2.37 # of alcohol problems
Standard Deviation 5.11
|
2.77 # of alcohol problems
Standard Deviation 6.24
|
Adverse Events
Arm 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 2
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place