NCT02952495

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

  1. 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2013

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

October 27, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 2, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

January 10, 2018

Status Verified

January 1, 2018

Enrollment Period

4.9 years

First QC Date

October 27, 2016

Last Update Submit

January 8, 2018

Conditions

Alcohol ConsumptionDrug-Food Interaction

Keywords

Alcohol ConsumptionOlder Adults

Outcome Measures

Primary Outcomes (2)

  • Alcohol Risk Score Baseline

    Health and drinking patterns are accounted at baseline

    Alcohol Risk Score at Baseline

  • Alcohol Risk Score 6 months

    Health and drinking patterns are accounted at 6 months

    Change from Baseline Alcohol Risk Score at 6 months

Secondary Outcomes (1)

  • Costs and cost effectiveness

    Six months

Study Arms (2)

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.

Behavioral: Online alcohol educational class

No intervention

NO INTERVENTION

Participants will NOT Participate in the online alcohol education class.

Interventions

Online alcohol educational classBEHAVIORAL

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.

Online alcohol educational class

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arlene Fink Associates

Pacific Palisades, California, 90272, United States

Location

Related Publications (1)

  • 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.

    PMID: 26832213RESULT

Related Links

MeSH Terms

Conditions

Alcohol Drinking

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Drinking BehaviorBehavior

Intervention Hierarchy (Ancestors)

AlcoholsOrganic Chemicals

Study Officials

  • Arlene Fink

    Arlene Fink Associates

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 27, 2016

First Posted

November 2, 2016

Study Start

September 1, 2013

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

January 10, 2018

Record last verified: 2018-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)