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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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
- 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
- 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.
- Conditions
- Alcohol Consumption, Drug-Food Interaction
- 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 group | Role | What they receive |
|---|---|---|
| Online alcohol educational class | Experimental | 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. Receives: Behavioral: Online alcohol educational class |
| No intervention | No intervention | Participants 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.
Alcohol Risk Score Baseline
Health and drinking patterns are accounted at baseline
Measured: Alcohol Risk Score at Baseline
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)
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.
- First posted2 Nov 2016 (estimated)
- Study startSep 2013
- Primary completionAug 2018 (estimated)
- Study completionAug 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol ConsumptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Arlene Fink Associates
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Southern California
- Responsible party
- Principal investigator, Arlene Fink, Arlene Fink Associates
- Investigators
- Arlene Fink, Principal investigator, Arlene Fink Associates
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
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Education to Inform the Elderly About Age-related Alcohol Risks: A Randomized Trial of Effectiveness and Costs
- ClinicalTrials.gov ID
- NCT02952495
- Acronym / sponsor ID
- 2R44AA022014-02
- Conditions
- Alcohol Consumption, Drug-Food Interaction
- Keywords
- Alcohol Consumption, Older Adults
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Arlene Fink AssociatesIndustry (pharma, biotech, devices)
- Collaborators
- University of Southern California
- Study start
- Sep 2013
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 2 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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
- 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Online alcohol educational class | Experimental | Behavioral: Online alcohol educational classParticipants 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. |
| No intervention | No intervention | –Participants will NOT Participate in the online alcohol education class. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Non alcohol drinkers (having no drinks containing alcohol in the past 3 months)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online alcohol educational classParticipants 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. | Behavioural | Online alcohol educational class |
Primary outcome
Alcohol Risk Score Baseline
Time frame: Alcohol Risk Score at Baseline
Health and drinking patterns are accounted at baseline
Alcohol Risk Score 6 months
Time frame: Change from Baseline Alcohol Risk Score at 6 months
Health and drinking patterns are accounted at 6 months
1 secondary outcome
Costs and cost effectiveness
Time frame: Six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2018.
- Results publication: PubMed 26832213Fink 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.
- 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.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arlene Fink principal investigator
Arlene Fink Associates
1 site in 1 country: see every site and its status.
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.