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Healthy Living as You Age (HLAYA)

Primary Purpose

Alcohol Related Disorders, Alcohol Drug Interactions

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Brief advice
Sponsored by
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Alcohol Related Disorders focused on measuring Alcohol, Comorbidity, Aging, Brief Advice, Randomized Trial

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • UCLA Department of Medicine, Geriatrics Research Center

Outcomes

Primary Outcome Measures

Reducing at-risk drinking

Secondary Outcome Measures

Reducing alcohol use
Reducing the number of risks among those still considered at-risk drinkers.

Full Information

First Posted
September 19, 2006
Last Updated
July 10, 2009
Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT00379093
Brief Title
Healthy Living as You Age
Acronym
HLAYA
Official Title
Preventing Harm From Alcohol Use in Older Adults
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
August 2003 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Related Disorders, Alcohol Drug Interactions
Keywords
Alcohol, Comorbidity, Aging, Brief Advice, Randomized Trial

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
631 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Brief advice
Intervention Description
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.
Primary Outcome Measure Information:
Title
Reducing at-risk drinking
Time Frame
12 month
Secondary Outcome Measure Information:
Title
Reducing alcohol use
Time Frame
12 month
Title
Reducing the number of risks among those still considered at-risk drinkers.
Time Frame
12 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alison A. Moore, MD, MPH
Organizational Affiliation
UCLA DOM-Geriatrics
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA Department of Medicine, Geriatrics Research Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Healthy Living as You Age

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