N/A
N=146
Telephone Disease Management At-Risk Drinking (TDM II)
Alcohol Abuse
Bottom Line
View on ClinicalTrials.gov: NCT00123409 ↗Enrolled (actual)
146
Serious AEs
0.0%
Results posted
Nov 2014
Primary outcome: Primary: Reduced Alcohol Use — 14.96; 15.52 Days drinking
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Telephone disease management (Behavioral); Usual Care (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- US Department of Veterans Affairs
- Primary completion
- Aug 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Reduced Alcohol Use |
14.96; 15.52 | — |
| SECONDARY Reduced Problems Related to Alcohol |
2.37; 2.77 | — |
Summary
The aim of this study is to test for improvements in treatment outcomes for primary care patients with at-risk drinking when cared for using telephone disease management (TDM) compared to those treated with usual care. Based on our pilot data, TDM for at-risk drinking may be a viable method for reducing alcohol consumption in this population.
Hypotheses: The hypotheses for this research plan are: 1. A significantly greater proportion of patients assigned to TDM will obtain improvement in drinking outcomes compared to usual care. 2. TDM will lead to greater access to behavioral health care and higher intensity of treatment relative to usual care. This effect will be moderated by logistics such as transportation problems, physical functioning, and employment status. 3. More patients assigned to TDM will receive guideline adherent care.
Eligibility Criteria
Inclusion Criteria
- be 18 years of age and over, male or female.
- meet criteria for at-risk drinking as defined by drinking more than 21 standard drinks per week (14 for women or those over age 65).
Exclusion Criteria
- show an absence of any of the following:
- active suicidal ideation,
- regular current use of illicit substances other than alcohol
- diagnosis of current alcohol dependence
- current hallucinations and delusions
- current symptoms of PTSD
- a history of mania or hypomania.
- have adequate hearing to participate in telephone assessments and access to a telephone. Subjects will also show an absence of other barriers to verbal communication (e.g., aphasia) and will be cognitively intact (Brief Orientation Memory and Concentration task greater than 15 for those over age 54).
- not actively participating in specialized addiction treatment within the prior 3-months.
- not currently enrolled in another clinical trial
- not expected to move from the VISN 4 area within 12 months
Data sourced from ClinicalTrials.gov (NCT00123409). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.