Project SHARE (Senior Health and Alcohol Risk Education)
2012年8月11日 更新者：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.
調査の概要
詳細な説明
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."
研究の種類
介入
入学 (実際)
1186
段階
- フェーズ2
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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California
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Santa Barbara、California、アメリカ、93111
- Sansum-Santa Barbara Medical Foundation Clinics
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
60年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：ヘルスサービス研究
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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介入なし：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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実験的：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.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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At-risk drinking at 6 month followup
時間枠：6 months
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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
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At-risk drinking at 12 month followup
時間枠：12 months
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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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12 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Health-related quality of life at 6 months
時間枠：6 months
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Health-related quality of life (HRQL) is measured using the SF-6D.
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6 months
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Depressive symptoms
時間枠：12 months
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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
時間枠：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
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Healthcare utilization
時間枠：12 months (cumulative)
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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)
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Outpatient service costs
時間枠：12 months (cumulative)
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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)
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Direct recruitment and intervention costs
時間枠：12 months (cumulative)
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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
時間枠：12 months
|
Health-related quality of life (HRQL) is measured using the SF-6D.
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12 months
|
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Mental Composite Score at 12 month followup
時間枠：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
|
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Physical Composite Score at 6 month followup
時間枠：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
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Susan Ettner, PhD、University of California, Los Angeles
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2005年5月1日
一次修了 (実際)
2008年9月1日
研究の完了 (実際)
2009年9月1日
試験登録日
最初に提出
2005年4月6日
QC基準を満たした最初の提出物
2005年4月6日
最初の投稿 (見積もり)
2005年4月7日
学習記録の更新
投稿された最後の更新 (見積もり)
2012年8月14日
QC基準を満たした最後の更新が送信されました
2012年8月11日
最終確認日
2010年9月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Patient-provider educationの臨床試験
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Fondazione Poliambulanza Istituto Ospedalieroわからない
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Jewish General HospitalUniversity of Manitoba; McGill University Health Centre/Research Institute of the McGill University... と他の協力者募集
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University of SheffieldUniversity of Liverpool; University of Manchester; University of Melbourne積極的、募集していない
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Imperial College Healthcare NHS Trust完了