Healthy Living as You Age

Alcohol Related Disorders Clinical Trial

— HLAYA  

Official title:

Preventing Harm From Alcohol Use in Older Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00379093
• Other study ID #: NIAAA-MOO-013937
• Secondary ID: NIH Grant 5 RO1
• Status: Completed
• Phase: Phase 2
• First received: September 19, 2006
• Last updated: July 10, 2009
• Start date: August 2003
• Est. completion date: July 2008

Study information

• Verified date: July 2009
• Source: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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:

1. A personalized risk report;

2. An educational booklet titled "Healthy Drinking as You Age";

3. A drinking diary;

4. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 631
• Est. completion date: July 2008
• Est. primary completion date: April 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 55 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Alcohol Drug Interactions
• Alcohol Related Disorders
• Alcohol-Related Disorders

Intervention

Behavioral:
• Brief advice
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.

Locations

Country	Name	City	State
United States	UCLA Department of Medicine, Geriatrics Research Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reducing at-risk drinking		12 month	Yes
Secondary	Reducing alcohol use		12 month	Yes
Secondary	Reducing the number of risks among those still considered at-risk drinkers.		12 month	Yes