- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00107640
Project SHARE (Senior Health and Alcohol Risk Education)
11. august 2012 opdateret af: Susan Ettner, University of California, Los Angeles
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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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."
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
1186
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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California
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Santa Barbara, California, Forenede Stater, 93111
- Sansum-Santa Barbara Medical Foundation Clinics
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
60 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- 60 and over
- At-risk drinkers
- Patient of participating physician
Exclusion Criteria:
- 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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Ingen indgriben: Usual care
Patients not assigned to the experimental condition received usual care, which may or may not have included alcohol education.
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Eksperimentel: Patient-provider education
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.
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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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
At-risk drinking at 6 month followup
Tidsramme: 6 months
|
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
Tidsramme: 12 months
|
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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Health-related quality of life at 6 months
Tidsramme: 6 months
|
Health-related quality of life (HRQL) is measured using the SF-6D.
|
6 months
|
Depressive symptoms
Tidsramme: 12 months
|
Depressive symptoms are measured using the Geriatric Depression Scale.
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12 months
|
Mental Composite Score at 6 months
Tidsramme: 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).
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6 months
|
Healthcare utilization
Tidsramme: 12 months (cumulative)
|
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.
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12 months (cumulative)
|
Outpatient service costs
Tidsramme: 12 months (cumulative)
|
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.
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12 months (cumulative)
|
Direct recruitment and intervention costs
Tidsramme: 12 months (cumulative)
|
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.
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12 months (cumulative)
|
Health-related quality of life at 12 month followup
Tidsramme: 12 months
|
Health-related quality of life (HRQL) is measured using the SF-6D.
|
12 months
|
Mental Composite Score at 12 month followup
Tidsramme: 12 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).
|
12 months
|
Physical Composite Score at 6 month followup
Tidsramme: 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).
|
6 months
|
Physical Composite Score at 12 month followup
Tidsramme: 12 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).
|
12 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Susan Ettner, PhD, University of California, Los Angeles
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
- 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.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. maj 2005
Primær færdiggørelse (Faktiske)
1. september 2008
Studieafslutning (Faktiske)
1. september 2009
Datoer for studieregistrering
Først indsendt
6. april 2005
Først indsendt, der opfyldte QC-kriterier
6. april 2005
Først opslået (Skøn)
7. april 2005
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
14. august 2012
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
11. august 2012
Sidst verificeret
1. september 2010
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- NIAAATAL13990
- R01AA013990 (U.S. NIH-bevilling/kontrakt)
- 5R01AA013990-02 (U.S. NIH-bevilling/kontrakt)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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