- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00107640
Project SHARE (Senior Health and Alcohol Risk Education)
11. august 2012 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert 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."
Studietype
Intervensjonell
Registrering (Faktiske)
1186
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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California
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Santa Barbara, California, Forente stater, 93111
- Sansum-Santa Barbara Medical Foundation Clinics
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
60 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Ingen inngripen: 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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Eksperimentell: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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.
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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 |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Health-related quality of life at 6 months
Tidsramme: 6 months
|
Health-related quality of life (HRQL) is measured using the SF-6D.
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6 months
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Depressive symptoms
Tidsramme: 12 months
|
Depressive symptoms are measured using the Geriatric Depression Scale.
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12 months
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Mental Composite Score at 6 months
Tidsramme: 6 months
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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)
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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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Susan Ettner, PhD, University of California, Los Angeles
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Hjelpsomme linker
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. mai 2005
Primær fullføring (Faktiske)
1. september 2008
Studiet fullført (Faktiske)
1. september 2009
Datoer for studieregistrering
Først innsendt
6. april 2005
Først innsendt som oppfylte QC-kriteriene
6. april 2005
Først lagt ut (Anslag)
7. april 2005
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
14. august 2012
Siste oppdatering sendt inn som oppfylte QC-kriteriene
11. august 2012
Sist bekreftet
1. september 2010
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- NIAAATAL13990
- R01AA013990 (U.S. NIH-stipend/kontrakt)
- 5R01AA013990-02 (U.S. NIH-stipend/kontrakt)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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