- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00379093
Healthy Living as You Age (HLAYA)
Preventing Harm From Alcohol Use in Older Adults
Study Overview
Status
Intervention / Treatment
Detailed Description
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:
- 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.
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
California
-
Los Angeles, California, United States, 90024
- UCLA Department of Medicine, Geriatrics Research Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- At least 55 years of age
- Seeing a participating physician (internists or family physicians employed at any of the participating sites)
- Have had at least one alcoholic drink in the last week
Exclusion Criteria:
- Too ill to participate
- Have received substance abuse services in past 3 months
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Reducing at-risk drinking
Time Frame: 12 month
|
12 month
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Reducing alcohol use
Time Frame: 12 month
|
12 month
|
Reducing the number of risks among those still considered at-risk drinkers.
Time Frame: 12 month
|
12 month
|
Collaborators and Investigators
Investigators
- Principal Investigator: Alison A. Moore, MD, MPH, UCLA DOM-Geriatrics
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIAAA-MOO-013937
- NIH Grant 5 RO1 AA 013937
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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