A Phase 2 interventional study of Brief advice in Alcohol Related Disorders and Alcohol Drug Interactions, sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA). Completed at 1 site in United States. Open to participants aged 55 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-07-13.
Sponsored by National Institute on Alcohol Abuse and Alcoholism (NIAAA) · Phase 2, Interventional, and Prevention
Older persons who drink can be vulnerable to negative consequences of drinking. This trial aims to prevent harm from alcohol use in older adults through a program of screening and brief advice followed up with several health education phone calls.
Approximately 50% of persons aged 65 years and older drink alcohol. Older persons are particularly susceptible to adverse consequences of drinking such as falls, depression, sleep disorders, stomach upset, hypertension, and alcohol/drug interactions. This is because of age-related changes in the body that affect how older persons react to alcohol and also because of the age-associated increases in illness and medication use.
In the current project we aim to see if screening and brief advice given to older risky drinkers in a physician's office followed by up to 3 health education phone calls may reduce their risks associated with alcohol use. We plan to use a newly developed and tested measure, the Comorbidity Alcohol Risk Evaluation Tool (CARET), to screen for older persons (aged 55 and older) whose use of alcohol alone or in combination with their illnesses, symptoms, and medication use may be causing them harm, or increasing their risk for harm. Persons whose responses on the CARET indicate they might be risky drinkers will be randomized to receive either a brief intervention to reduce their risks or usual care.
The intervention will have the following components:
A) At the time of the recruitment visit, all intervention group patients will receive:
B) After the recruitment visit, all intervention group patients will receive up to 3 telephone calls from a health educator. After each call, intervention group patients may choose to receive a letter updating their health risks. Also, at the conclusion of their interaction with the health educator, they may choose to have a letter summarizing the calls sent to their physician.
At the time of the recruitment visit, control group patients will receive a booklet on a variety of healthy behaviors titled "Healthy Living as You Age." Both control and intervention group patients will receive a telephone call from a research associate 3 months and 12 months after initial enrollment in the study to administer the CARET again.
We will analyze our results to look for differences between the intervention and control groups at 12 months in the a) proportions of them identified as risky drinkers by the CARET; b) the amount they drink; c) the numbers of risks identifying those persons who are still risky drinkers and d) the difference in their expectations regarding aging.
143 studies on the registry are indexed under Alcohol-Related Disorders; 22 are open to participants now.
This study's enrollment of 631 is above the median of 113 across 120 interventional studies indexed under Alcohol-Related Disorders.
Browse Alcohol-Related Disorders studies →National Institute on Alcohol Abuse and Alcoholism (NIAAA) is the lead sponsor of 98 studies on the registry; 17 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 8 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The intervention will have the following components: A) At the time of the recruitment visit, all intervention group patients will receive: * A personalized risk report; * An educational booklet titled "Healthy Drinking as You Age"; * A drinking diary; * Brief advice to reduce their drinking by their physicians; B) After the recruitment visit, all intervention group patients will receive up to 3 telephone calls from a health educator. After each call, intervention group patients may choose to receive a letter updating their health risks. Also, at the conclusion of their interaction with the health educator, they may choose to have a letter summarizing the calls sent to their physician.
Reducing at-risk drinking
Time frame: 12 month
Reducing alcohol use
Time frame: 12 month
Reducing the number of risks among those still considered at-risk drinkers.
Time frame: 12 month
This study is completed, as verified in Jul 2009. You cannot join it, but the record below documents what was studied.
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National Institute on Alcohol Abuse and Alcoholism (NIAAA)