AzTrials
AzTrials

Alcohol Related DisordersPhase 2HLAYANCT00379093

Healthy Living as You Age

A Phase 2 study testing Brief advice in people with Alcohol Related Disorders and Alcohol Drug Interactions, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 55 years and olderHealthy volunteers can take part
What is being tested?
Brief advice
How many people
631 participants
Where
1 siteUnited States
Study dates
Aug 2003to Jul 2008
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Too ill to participate
  • Have received substance abuse services in past 3 months

Trial locations and contacts

1 site in 1 country.

United States1 site
  • UCLA Department of Medicine, Geriatrics Research Center

    Los Angeles, California, 90024

Other trials in United States

About this study

Official title: Preventing Harm From Alcohol Use in Older Adults

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.

Read the 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:

  1. At the time of the recruitment visit, all intervention group patients will receive:
  2. A personalized risk report;
  3. An educational booklet titled "Healthy Drinking as You Age";
  4. A drinking diary;
  5. Brief advice to reduce their drinking by their physicians;
  6. 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.

Being tested
Brief advice
Keywords
Alcohol, Comorbidity, Aging, Brief Advice, Randomized Trial
Medical subject headings
Alcohol-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Brief adviceBehavioural

    The intervention will have the following components:

    1. 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;
    1. 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Reducing at-risk drinking

    Measured: 12 month

Secondary outcomes (2)
  1. Reducing alcohol use

    Measured: 12 month

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

    Measured: 12 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2006 (estimated)
  2. Study startAug 2003
  3. Primary completionApr 2007
  4. Study completionJul 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
631 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00379093
Sponsor's protocol ID
NIAAA-MOO-013937
Other IDs
NIH Grant 5 RO1 AA 013937
Acronym
HLAYA
Status last verified
Jul 2009
First submitted
19 Sep 2006
Last updated
13 Jul 2009
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Brief advice in people with Alcohol Related Disorders and Alcohol Drug Interactions, run by National Institute on Alcohol Abuse and Alcoholism (NIAAA) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reducing at-risk drinking (time frame: 12 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2009.

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