NCT00107640

Brief Summary

Older adults become more sensitive to alcohol, and alcohol also interacts adversely with their common medical conditions and medications. The aim of Project SHARE (Senior Health and Alcohol Risk Education) is to see whether patient and provider education can decrease risky alcohol use and reduce health care costs in persons 60 years of age and older.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,186

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2005

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

April 6, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 7, 2005

Completed
24 days until next milestone

Study Start

First participant enrolled

May 1, 2005

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

August 14, 2012

Status Verified

September 1, 2010

Enrollment Period

3.3 years

First QC Date

April 6, 2005

Last Update Submit

August 11, 2012

Conditions

Alcohol Consumption

Keywords

At-risk drinkingAlcohol educationEffectivenessCost-effectiveness

Outcome Measures

Primary Outcomes (2)

  • At-risk drinking at 6 month followup

    At-risk drinking is alcohol use that (either alone or in conjunction with selected comorbidities, symptoms and/or medications) poses health risks. It is measured using the CARET instrument developed by Moore and colleagues.

    6 months

  • At-risk drinking at 12 month followup

    At-risk drinking is alcohol use that (either alone or in conjunction with selected comorbidities, symptoms and/or medications) poses health risks. It is measured using the CARET instrument developed by Moore and colleagues.

    12 months

Secondary Outcomes (10)

  • Health-related quality of life at 6 months

    6 months

  • Depressive symptoms

    12 months

  • Mental Composite Score at 6 months

    6 months

  • Healthcare utilization

    12 months (cumulative)

  • Outpatient service costs

    12 months (cumulative)

  • +5 more secondary outcomes

Study Arms (2)

Usual care

NO INTERVENTION

Patients not assigned to the experimental condition received usual care, which may or may not have included alcohol education.

Patient-provider education

EXPERIMENTAL

Experimental patients received an intervention consisting of the following components: written reports and educational materials, a telephone health educator intervention (at baseline, 3 and 6 months), and a brief provider intervention.

Behavioral: Patient-provider education

Interventions

Patient-provider educationBEHAVIORAL

Experimental patients received an intervention consisting of the following components: written reports and educational materials, a telephone health educator intervention (at baseline, 3 and 6 months), and a brief provider intervention.

Patient-provider education

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • and over
  • At-risk drinkers
  • Patient of participating physician

You may not qualify if:

  • Severe cognitive impairment
  • Terminally ill or deceased
  • Expected to move out of area or into nursing home within following year
  • Could not fill out written surveys in English
  • Likely dependent drinker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sansum-Santa Barbara Medical Foundation Clinics

Santa Barbara, California, 93111, United States

Location

Related Publications (2)

  • Barnes AJ, Xu H, Tseng CH, Ang A, Tallen L, Moore AA, Marshall DC, Mirkin M, Ransohoff K, Duru OK, Ettner SL. The Effect of a Patient-Provider Educational Intervention to Reduce At-Risk Drinking on Changes in Health and Health-Related Quality of Life Among Older Adults: The Project SHARE Study. J Subst Abuse Treat. 2016 Jan;60:14-20. doi: 10.1016/j.jsat.2015.06.019. Epub 2015 Jul 8.

    PMID: 26254687DERIVED

  • Ettner SL, Xu H, Duru OK, Ang A, Tseng CH, Tallen L, Barnes A, Mirkin M, Ransohoff K, Moore AA. The effect of an educational intervention on alcohol consumption, at-risk drinking, and health care utilization in older adults: the Project SHARE study. J Stud Alcohol Drugs. 2014 May;75(3):447-57. doi: 10.15288/jsad.2014.75.447.

    PMID: 24766757DERIVED

Related Links

MeSH Terms

Conditions

Alcohol Drinking

Condition Hierarchy (Ancestors)

Drinking BehaviorBehavior

Study Officials

  • Susan Ettner, PhD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 6, 2005

First Posted

April 7, 2005

Study Start

May 1, 2005

Primary Completion

September 1, 2008

Study Completion

September 1, 2009

Last Updated

August 14, 2012

Record last verified: 2010-09

Locations

US(1)