Online Education to Inform the Elderly About Age-related Alcohol Risks
Primary Purpose
Alcohol Consumption, Drug-Food Interaction
Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Online alcohol educational class
Sponsored by

About this trial
This is an interventional prevention trial for Alcohol Consumption focused on measuring Alcohol Consumption, Older Adults
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Non alcohol drinkers (having no drinks containing alcohol in the past 3 months)
Sites / Locations
- Arlene Fink Associates
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Online alcohol educational class
No intervention
Arm Description
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.
Participants will NOT Participate in the online alcohol education class.
Outcomes
Primary Outcome Measures
Alcohol Risk Score Baseline
Health and drinking patterns are accounted at baseline
Alcohol Risk Score 6 months
Health and drinking patterns are accounted at 6 months
Secondary Outcome Measures
Costs and cost effectiveness
Costs of achieving changes in drinking patterns and risks
Full Information
NCT ID
NCT02952495
First Posted
October 27, 2016
Last Updated
January 8, 2018
Sponsor
Arlene Fink Associates
Collaborators
University of Southern California
1. Study Identification
Unique Protocol Identification Number
NCT02952495
Brief Title
Online Education to Inform the Elderly About Age-related Alcohol Risks
Official Title
Online Education to Inform the Elderly About Age-related Alcohol Risks: A Randomized Trial of Effectiveness and Costs
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
September 2013 (undefined)
Primary Completion Date
August 2018 (Anticipated)
Study Completion Date
August 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Arlene Fink Associates
Collaborators
University of Southern California
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Consumption, Drug-Food Interaction
Keywords
Alcohol Consumption, Older Adults
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Online alcohol educational class
Arm Type
Experimental
Arm Description
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.
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
Participants will NOT Participate in the online alcohol education class.
Intervention Type
Behavioral
Intervention Name(s)
Online alcohol educational class
Intervention Description
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.
Primary Outcome Measure Information:
Title
Alcohol Risk Score Baseline
Description
Health and drinking patterns are accounted at baseline
Time Frame
Alcohol Risk Score at Baseline
Title
Alcohol Risk Score 6 months
Description
Health and drinking patterns are accounted at 6 months
Time Frame
Change from Baseline Alcohol Risk Score at 6 months
Secondary Outcome Measure Information:
Title
Costs and cost effectiveness
Description
Costs of achieving changes in drinking patterns and risks
Time Frame
Six months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Non alcohol drinkers (having no drinks containing alcohol in the past 3 months)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arlene Fink
Organizational Affiliation
Arlene Fink Associates
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arlene Fink Associates
City
Pacific Palisades
State/Province
California
ZIP/Postal Code
90272
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
26832213
Citation
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.
Results Reference
result
Links:
URL
http://www.researchprotocols.org/2016/1/e11/
Description
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.
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Online Education to Inform the Elderly About Age-related Alcohol Risks
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