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=5 Participants	57 years STANDARD_DEVIATION 13.9 • n=7 Participants	57.1 years STANDARD_DEVIATION 14 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	67 Participants n=5 Participants	69 Participants n=7 Participants	136 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	30 Participants n=5 Participants	33 Participants n=7 Participants	63 Participants n=5 Participants
Race (NIH/OMB) White	38 Participants n=5 Participants	38 Participants n=7 Participants	76 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	68 participants n=5 Participants	71 participants n=7 Participants	139 participants n=5 Participants
# of Days Drinking in last 28 days	19.53 # of days drinking STANDARD_DEVIATION 9.44 • n=5 Participants	20.2 # of days drinking STANDARD_DEVIATION 8.12 • n=7 Participants	19.9 # of days drinking STANDARD_DEVIATION 8.8 • n=5 Participants
Problems related to alcohol	4.31 # problems STANDARD_DEVIATION 5.52 • n=5 Participants	4.7 # problems STANDARD_DEVIATION 5.52 • n=7 Participants	4.5 # problems STANDARD_DEVIATION 5.52 • n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Alcohol 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 months

The 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

David Oslin

Philadelphia VAMC

Phone: 2158235894

Email: dave.oslin@upenn.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place