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Alcohol ConsumptionPhase 2NCT00107640

Project SHARE (Senior Health and Alcohol Risk Education)

A Phase 2 study testing Patient-provider education in people with Alcohol Consumption, run by University of California, Los Angeles at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Alcohol Consumption
What is being tested?
Patient-provider education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,186 participants
Where
1 siteUnited States
Study dates
May 2005to Sep 2009
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 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Sansum-Santa Barbara Medical Foundation Clinics

    Santa Barbara, California, 93111

Other trials in United States

About this study

Official title: Costs of Preventing Alcohol Problems in Older Adults

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.

Read the detailed description

Alcohol use in the elderly is an increasingly important public health problem. Alcohol-related risks and problems in older persons may come from the interaction between alcohol and diminished health or medication use. The proposed study is a randomized trial of the effectiveness and cost-effectiveness of an integrated patient-provider intervention to prevent risky alcohol use among older adults. The intervention will include a tested screening and education system that was developed especially for older adults and their providers, supplemented by a well-established intervention for physicians. The proposed research design involves randomization of 31 primary care physicians in seven clinics and their eligible patients aged 60+ to the intervention versus "usual care."

Being tested
Patient-provider education
Keywords
At-risk drinking, Alcohol education, Effectiveness, Cost-effectiveness
Medical subject headings
Alcohol Drinking

What participants receive

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

  • Patient-provider educationBehavioural

    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.

Study groups in NCT00107640
Study groupRoleWhat they receive
Usual careNo interventionPatients not assigned to the experimental condition received usual care, which may or may not have included alcohol education.
Patient-provider educationExperimentalExperimental 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.
Receives: Behavioral: Patient-provider education

What is being measured

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

  1. 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.

    Measured: 6 months

  2. 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.

    Measured: 12 months

Secondary outcomes (10)

  1. Health-related quality of life at 6 months

    Health-related quality of life (HRQL) is measured using the SF-6D.

    Measured: 6 months

  2. Depressive symptoms

    Depressive symptoms are measured using the Geriatric Depression Scale.

    Measured: 12 months

  3. Mental Composite Score at 6 months

    We used self-reported SF12 data from baseline, 6- and 12-month written surveys to construct Mental Composite Score (MCS) and Physical Composite Score (PCS).

    Measured: 6 months

  4. Healthcare utilization

    We used self-reported data from 3-month, 6-month and 12-month written patient surveys to measure cumulative healthcare utilization by type (e.g., hospitalizations, emergency department visits, physician visits, etc.) over the twelve months following baseline.

    Measured: 12 months (cumulative)

  5. Outpatient service costs

    We used administrative data on clinic-based services linked to Medicare fee schedules to construct cumulative measures of outpatient service costs (from the Medicare perspective) for the twelve months following baseline.

    Measured: 12 months (cumulative)

  6. Direct recruitment and intervention costs

    We collected data on the resources used directly for recruitment (e.g., clinic-based staff time, phones, postage, etc.) and the intervention (e.g., cost of health educator time, supplies, opportunity costs of the physician's time, etc.) spent on the intervention, to construct overall measures of the per-patient cost of recruitment and intervention.

    Measured: 12 months (cumulative)

  7. Health-related quality of life at 12 month followup

    Health-related quality of life (HRQL) is measured using the SF-6D.

    Measured: 12 months

  8. Mental Composite Score at 12 month followup

    We used self-reported SF12 data from baseline, 6- and 12-month written surveys to construct Mental Composite Score (MCS) and Physical Composite Score (PCS).

    Measured: 12 months

  9. Physical Composite Score at 6 month followup

    We used self-reported SF12 data from baseline, 6- and 12-month written surveys to construct Mental Composite Score (MCS) and Physical Composite Score (PCS).

    Measured: 6 months

  10. Physical Composite Score at 12 month followup

    We used self-reported SF12 data from baseline, 6- and 12-month written surveys to construct Mental Composite Score (MCS) and Physical Composite Score (PCS).

    Measured: 12 months

Timeline

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

  1. First posted7 Apr 2005 (estimated)
  2. Study startMay 2005
  3. Primary completionSep 2008
  4. Study completionSep 2009

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
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
1,186 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00107640
Sponsor's protocol ID
NIAAATAL13990
Other IDs
R01AA013990, 5R01AA013990-02
Status last verified
Sep 2010
First submitted
6 Apr 2005
Last updated
14 Aug 2012
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 26254687

  • 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.

    PubMed 24766757

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Patient-provider education in people with Alcohol Consumption, run by University of California, Los Angeles 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 3 inclusion and 5 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: finished, as of the sponsor's last update on 14 Aug 2012. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

At-risk drinking at 6 month followup (time frame: 6 months). 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 NCT00107640, which also lists 2 linked publications.

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 14 Aug 2012.

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