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Evaluation of a Computerized Opioid Overdose Prevention Program

2017年10月12日 更新者:Johns Hopkins University

Development and Validation of a Computerized Opioid Overdose Intervention.

Unintentional fatal drug overdose (OD) is now the 2nd leading cause of accidental death in the general population. Fatal OD from opioid analgesics specifically has increased over 400% between 1999 and 2008, and nonfatal overdose occurs at a rate 3-7 greater than fatal OD. Unintentional opioid OD is a public health crisis in several societal populations including drug users, patients being treated for chronic pain, elderly individuals, adolescents, and children. Educational interventions have been developed to increase knowledge regarding opioid OD risk factors, symptoms, and appropriate responses, however no randomized controlled evaluations of these interventions have been conducted. Within-subject evaluations report immediate and sustained increases in participant knowledge and behavior change, yet these programs suffer from limitations that may limit their widespread dissemination. Thus, there is an urgent, critical need to develop an opioid OD educational intervention that can be accessed by a broad audience, and produces immediate and sustained gains in knowledge in an easily administered and cost-effective way. This study will develop a web-based, computerized, interactive, opioid OD education training program that will incorporate multi-media learning components and fluency training to produce knowledge gains. This program will be evaluated using a randomized, controlled comparison of the active intervention against two control interventions. Participants will be recruited from a brief inpatient detoxification (n=75), will receive the intervention immediately upon completing the detoxification (post-treatment), and will complete 2 follow-up visits to evaluate sustained knowledge. The primary outcome will be percent change from baseline on a knowledge test that is administered immediately before and after the intervention, and at a 1 and 3-month follow-up visit. Secondary outcomes will include self-reported behavior change and participant acceptance of the intervention. The study hypothesis is that participants who receive the primary intervention will evidence the largest increase in knowledge gain and retention over time, compared to the control groups. The rationale and public health benefit of this research cannot be understated- this project will make available a brief, empirically-supported intervention that can be administered quickly and easily within hundreds of settings (e.g., treatment centers, prisons and jails, needle exchange centers, primary care offices, schools), and to diverse patient populations (e.g., drug users, chronic pain patients, elderly, student, children, parents). These outcomes are expected to have a positive impact because they will provide cheap, easily-administered intervention strategy that will help reduce the current national epidemic of opioid OD, and will expand the use of computerized interventions to address public health issues more broadly.

調査の概要

研究の種類

介入

入学 (実際)

75

段階

  • 適用できない

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

    • Maryland
      • Baltimore、Maryland、アメリカ、21224
        • Johns Hopkins University Bayview Medical Campus

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

18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:

  • Age (>18yrs old)
  • Past yr diagnosis of opioid dependence
  • Recent completion of opioid detoxification

Exclusion Criteria:

  • Completion of local overdose prevention programs and/or beta-testing of the computerized intervention
  • Physical limitations that will prevent adequate seeing/hearing of the intervention, or from using computer

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:防止
  • 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
実験的:Computer + Fluency
Will receive computerized intervention and will be required to periodically demonstrate mastery of information before proceeding to the next module in the computerized intervention.
アクティブコンパレータ:Computer Only
Will receive computerized intervention but will not be required to demonstrate mastery of information as part of the intervention.
アクティブコンパレータ:Treatment as Usual
Will receive publicly available pamphlets that contain same information as the computerized intervention. Will not have access to computerized intervention and will not be required to demonstrate mastery of information as part of the intervention.

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
Knowledge Gain
時間枠:Before the intervention (pre-test) and immediately after the intervention (post-test), an average of 10 minutes.

The primary outcome is based on performance in the randomized, controlled trial and is change from baseline on a knowledge test that is administered immediately before and after the intervention.

At the time of the study, no validated scales to assess general information regarding overdose in a true/false manner were available. Therefore the study developed a scale for the purpose of measuring knowledge increase. The scale included 51 items, rated as "true", "false", or "I don't know" (to discourage random guessing from resulting in accurate responses accidentally). The answers to all items were included as part of the intervention content so it was possible for every answer to be learned. The scale was summed together as a single measure of number correct responses (range 0-51) with no subscales. Higher values indicated more correct responses.

Before the intervention (pre-test) and immediately after the intervention (post-test), an average of 10 minutes.

二次結果の測定

結果測定
メジャーの説明
時間枠
Percent Participants Who Would Recommend the Intervention to a Family Member or Friend.
時間枠:Immediately after the intervention (an average of 10 minutes).
Participant willingness (yes or no) to recommend the intervention to a family member or friend.
Immediately after the intervention (an average of 10 minutes).

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。

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

2015年1月1日

一次修了 (実際)

2015年9月1日

研究の完了 (実際)

2015年9月1日

試験登録日

最初に提出

2014年1月15日

QC基準を満たした最初の提出物

2014年1月16日

最初の投稿 (見積もり)

2014年1月20日

学習記録の更新

投稿された最後の更新 (実際)

2017年11月17日

QC基準を満たした最後の更新が送信されました

2017年10月12日

最終確認日

2017年10月1日

詳しくは

本研究に関する用語

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。

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