[米国FDAが承認または認可していないデバイスの試験]
[米国FDAにより承認またはクリアされていないデバイスの試験]
調査の概要
詳細な説明
Participation in the study will last 12 months. Participants will be asked to complete assessments at 33 timepoints over the 12-month trial. This will include 1 screening assessment, 24 weekly assessments, 6 monthly assessments, and 2 follow-up assessments. All study assessments will be completed remotely.
Staff at each site will identify potential participants being treated with buprenorphine for opioid use disorder at their respective site. Providers will introduce the study and if interested, the participant will complete a screening assessment conducted by trained study staff to determine eligibility for the study.
Participants who are eligible will be enrolled into the study and given access to the KIOS app.
The active phase will include the first 6 months during which time participants will use the app, complete monthly assessments, and complete a weekly craving assessment. The second 6 months in the study will include two follow-up assessments at 9 months and 12 months post study start. At the end of the 12 months, app access will be removed. The follow up assessments will include the monthly assessments that were completed during the active phase, as well as the craving assessment. All assessments will be sent to the participants' email address for them to complete on any device with internet access. At the conclusion of 12 months of study participation, focus groups will be conducted with 25 of the participants to gather information about their perspectives on the app and its usability and features.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Elise Marino, PhD
- 電話番号：(210) 567-5399
- メール：marinoe@uthscsa.edu
研究連絡先のバックアップ
- 名前：McKenna Garcia
- 電話番号：(210) 450-7371
- メール：garciam98@uthscsa.edu
研究場所
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Texas
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San Antonio、Texas、アメリカ、78229
- University of Texas Health Science Center - Department of Psychiatry
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Male or female outpatients 18 years of age or older
- DSM-5 criteria for opioid use disorder
- Ability to access KIOS via smartphone or tablet
- Initiated buprenorphine treatment in the past 6 months
Exclusion Criteria:
- Unwilling or unable to comply with study requirements
- A psychiatric or medical condition interfering with ability to use the app
- Incarceration
- Suicide risk as determined by the treating medical clinician at the site
研究計画
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：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Treatment as usual and KIOS app
Participants will be set up onto their preferred device(s) with assistance from a research assistant.
KIOS will be accessible on all mobile devices as well as tablets.
Treatment as usual (TAU) will be administered to all participants.
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A digital health therapeutic intended to help individuals in recovery from opioid use disorder better self-manage their condition.
KIOS offers individualized, evidence-based behavioral intervention strategies responsive to the patients' current clinical status outside the setting of the doctor's office or treatment facility.
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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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Retention in treatment
時間枠：Baseline to 1 year
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The number of days from the start of the one-year intervention until the participant either leaves the trial or completes the trial.
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Baseline to 1 year
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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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Diagnostic Statistical Manual Version 5 (DSM-5)
時間枠：Baseline to 12 months
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DSM-5 criteria describe OUD as a pattern of opioid use leading to problems or distress
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Baseline to 12 months
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Opioid Craving Scale
時間枠：Baseline to 12 months
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A brief 3-item measure used to measure opioid craving.
The scale consists of 3 items rated on a visual analog scale from 0-10.
Items are as follows: 1) How much do you currently crave opiates?; 2) In the past week, please rate how strong your desire to use opiates has been when something in the environment has reminded you of opiates?; and 3) Please imagine yourself in the environment in which you previously used opiates.
If you were in this environment today and if it were the time of day that you typically used opiates, what is the likelihood that you would use opiates today.
The total scores range from 3-30 with a higher score indicating more opioid craving.
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Baseline to 12 months
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Patient Health Questionnaire-9 (PHQ-9)
時間枠：Baseline to 12 months
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A self-administered 9-item depression module that scores each of the 9 DSM-V (Diagnostic and Statistical Manual of Mental Disorders, 5th edition).
Items are score 0 to 3, providing a 0 to 27 severity score.
Scores of 5, 10, 15, and 20 represent cutoff points for mild, moderate, moderately severe, and severe depression, respectively.
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Baseline to 12 months
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Generalized Anxiety Disorder-7 (GAD-7)
時間枠：Baseline to 12 months
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The Generalized Anxiety Disorder-7 (GAD-7)13 measures anxiety with 7 items scored from 0 to 3, providing a 0 to 21 severity score.
Scores of 5, 10, and 15 represent cutoff points for mild, moderate, and severe anxiety, espectively.
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Baseline to 12 months
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Treatment Progress and Recovery (TEA)
時間枠：6 to 12 months
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The TEA gauges progress in treatment and recovery within four domains established by prior research: substance use, health (physical or emotional), lifestyle (housing/living situation, family, employment, relationships), and community (obeying laws, responsible member of society).
For each area, the patient is asked to think about how much better things have become on a 10-point scale (1 = not better at all and 10 = very much better).
Scores range between 0-40, with a higher score indicating greater progress in treatment and recovery
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6 to 12 months
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System Usability Scale (SUS)
時間枠：6 months
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The System Usability Scale (SUS)15 is a 10-item measure for assessing a system's usability on a 5-point Likert scale from strongly agree to strongly disagree.
Scores are converted to a 100-point scale.
A score above a 68 would be considered above average usability.
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6 months
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KIOS User Satisfaction Survey
時間枠：6 months
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Participants complete a survey specific to KIOS regarding: (1) the content, appropriateness, and relevance of the advice; (2) enhancement of self-management skills; (3) selfawareness; and (4) overall satisfaction with health.
Survey items will be answered with level of agreement with a given statement recorded on a Likert-type 0 (Disagree) - 7 (Agree) scale.
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6 months
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協力者と研究者
捜査官
- 主任研究者：Elise Marino, PhD、The University of Texas Health Science Center at San Antonio
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
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。
オピオイド使用障害の臨床試験
KIOS Appの臨床試験
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