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Alcohol ConsumptionPhase 2NCT02952495

Online Education to Inform the Elderly About Age-related Alcohol Risks

A Phase 2 study testing Online alcohol educational class in people with Alcohol Consumption and Drug-Food Interaction, run by Arlene Fink Associates at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This proposed Phase 2 The Small Business Innovation Research study is a randomized trial of the effectiveness of "A Toast to Health in Later Life!" a web-based patient educational program designed to prevent hazardous and harmful drinking in older adults. The project's specific objectives are to 1. Read more about this study

Who is it for?
Ages 55 years and olderHealthy volunteers can take part
Conditions the study is for
Alcohol Consumption, Drug-Food Interaction
What is being tested?
Online alcohol educational class
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteUnited States
Study dates
Sep 2013to Aug 2018
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

  • 55 years of age or older
  • have had one or more drinks containing alcohol in the past 3 months
  • have an active email account
  • have access to high-speed Internet
  • are able and willing to spend about 30 minutes on three separate occasions to complete an online alcohol use class and answer questions in English

Who cannot join

  • Non alcohol drinkers (having no drinks containing alcohol in the past 3 months)

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Arlene Fink Associates

    Pacific Palisades, California, 90272

Other trials in United States

About this study

Official title: Online Education to Inform the Elderly About Age-related Alcohol Risks: A Randomized Trial of Effectiveness and Costs

This proposed Phase 2 The Small Business Innovation Research study is a randomized trial of the effectiveness of "A Toast to Health in Later Life!" a web-based patient educational program designed to prevent hazardous and harmful drinking in older adults. The project's specific objectives are to

  1. provide reliable information on the extent to which "A Toast to Health in Later Life!" reduces alcohol-related risks and problems among older patients who drink and
  2. evaluate the extent to which these reductions are associated with increases in health-related quality of life, patient knowledge and self-efficacy and decreases in the use of health services and the costs of care.
Read the detailed description

This proposed Phase 2 The Small Business Innovation Research study is a randomized trial of the effectiveness of "A Toast to Health in Later Life!" a web-based patient educational program designed to prevent hazardous and harmful drinking in older adults. The project's specific objectives are to 1) provide reliable information on the extent to which "A Toast to Health in Later Life!" reduces alcohol-related risks and problems among older patients who drink and 2) evaluate the extent to which these reductions are associated with increases in health-related quality of life, patient knowledge and self-efficacy and decreases in the use of health services and the costs of care. The proposal is being submitted in response to the The National Institute on Alcohol Abuse and Alcoholism's interest in the "development and evaluation of educational materials designed to intervene with the elderly around specific age-related risks for alcohol problems" and to the National Institute of Health's highest priority areas in health economics research because it aims to measure the actual or potential impact of a specific intervention "on healthcare utilization and health outcomes." The study will take place with 600 patients who currently drink and receive their care at a large community-based medical center in in L.A. County that serves a stable and diverse population. Older people can experience alcohol's unfavorable health effects even at relatively low consumption levels because of age-related physiological changes and drinking's potentially adverse interactions with chronic illness, increased medication-use and diminishing functional status. About 14.5% of older adults drink in excess of the The National Institute on Alcohol Abuse and Alcoholism's recommended limits. Excessive alcohol consumption is responsible for an average of 88,000 deaths and 2.5 million years of potential life lost each year in the U.S. and cost the 50 States a median of $2.9 billion in 2006. Most of the costs are due to binge drinking. According to The Centers for Disease Control and Prevention, older adults binge-drink more frequently than their younger counterparts, and drinking too much contributes to over 54 different injuries and diseases (including car crashes and violence). Further, the chance of getting sick and dying from alcohol problems increases significantly for those who binge drink more often. When health and drinking patterns are accounted for, about half of all older drinkers may be at risk for experiencing alcohol-related harm even if they drink within recommended limits. Considering that about 10,000 people will turn 65 every day for the next decade, and that the proportion of older adults will increase to more than 20% of the U.S. population by 2030, the number of older people with alcohol-related risks will increase even if drinking prevalence remains constant. Despite this, many physicians fail to discuss drinking with older patients, partly because they do not have the time and training to do so and partly because the available education focuses on younger drinkers. To complicate matters, observational evidence suggests that in some older adults, moderate consumption may have beneficial effects on cardiovascular functioning and mortality. "A Toast to Health in Later Life!" covers the spectrum of drinking and its benefits and risks. If effective and cost-effective, the product has the potential to achieve important clinical and societal benefits.

Being tested
Online alcohol educational class
Keywords
Alcohol Consumption, Older Adults
Medical subject headings
Alcohol Drinking

What participants receive

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

  • Online alcohol educational classBehavioural

    Participants will be asked to review an online alcohol education class. This is a web-based patient educational program designed to prevent hazardous and harmful drinking in older adults. The project's specific objectives are to 1) provide reliable information on the extent to which "A Toast to Health in Later Life!" reduces alcohol-related risks and problems among older patients who drink and 2) evaluate the extent to which these reductions are associated with increases in health-related quality of life, patient knowledge and self-efficacy and decreases in the use of health services and the costs of care.

Study groups in NCT02952495
Study groupRoleWhat they receive
Online alcohol educational classExperimentalParticipants will be asked to review an online alcohol education class. This is a web-based patient educational program designed to prevent hazardous and harmful drinking in older adults.
Receives: Behavioral: Online alcohol educational class
No interventionNo interventionParticipants will NOT Participate in the online alcohol education class.

What is being measured

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

  1. Alcohol Risk Score Baseline

    Health and drinking patterns are accounted at baseline

    Measured: Alcohol Risk Score at Baseline

  2. Alcohol Risk Score 6 months

    Health and drinking patterns are accounted at 6 months

    Measured: Change from Baseline Alcohol Risk Score at 6 months

Secondary outcomes (1)
  1. Costs and cost effectiveness

    Costs of achieving changes in drinking patterns and risks

    Measured: Six months

Timeline

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

  1. First posted2 Nov 2016 (estimated)
  2. Study startSep 2013
  3. Primary completionAug 2018 (estimated)
  4. Study completionAug 2018 (estimated)

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
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02952495
Sponsor's protocol ID
2R44AA022014-02
Status last verified
Jan 2018
First submitted
27 Oct 2016
Last updated
10 Jan 2018
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Fink A, Kwan L, Osterweil D, Van Draanen J, Cooke A, Beck JC. Assessing the Usability of Web-Based Alcohol Education for Older Adults: A Feasibility Study. JMIR Res Protoc. 2016 Feb 1;5(1):e11. doi: 10.2196/resprot.4545.

    PubMed 26832213

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Online alcohol educational class in people with Alcohol Consumption and Drug-Food Interaction, run by Arlene Fink Associates 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 5 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 10 Jan 2018. 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?

Results are not available in the source record.

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?

Alcohol Risk Score Baseline (time frame: Alcohol Risk Score at Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02952495, which also lists 1 linked publication.

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 10 Jan 2018.

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