Way to Cure HCV Adherence (WTC)
Way to Cure: Developing Effective Strategies to Promote Adherence to Hepatitis C Therapy Among Older Adults
調査の概要
詳細な説明
This 3-arm trial will field test the efficacy of "Way to Cure" intervention on medication adherence in Hepatitis C for 12 weeks. As part of routine clinical care all patients will receive medication counseling regarding proper use and side effects by trained nurses or pharmacists depending on the clinical site.
Arm 1: Control (n=20) - Monitoring pill box will be set into "quiet mode". This mode sends daily adherence data to the Way to Health platform each time the participant opens the pill bottle, however, does not remind the participant to take the medication. In the event no electronic signal is received by the platform for 96 hours, the RA will call the participant to assess any usability or connectivity issues.
Arm 2: Intervention - Reminders/Feedback (n=20) - Patients will receive tailored text message reminders to take the medication if in case the interval from last box opening is >30 hours (greater than 6 hours overdue). Patients will receive weekly text messages with summary cumulative adherence scores.
Arm 3: Intervention - Reminders/Feedback and Financial Incentives (n=20) - In addition to reminders with missed doses and weekly adherence feedback, patients in this arm will be eligible to receive a financial incentive each week they demonstrate perfect >85% adherence. The weekly adherence feedback message will also alert patients whether they earned the incentive for the past week.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19104
- University of Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19104
- Corporal Michael J. Crescenz VA Medical Center
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
a) age 50 older, b) prescribed a fixed dose combination HCV regimen containing sofosbuvir/ledipasvir for 12 weeks, and 3) willing to receive text message communications.
Exclusion Criteria:
a) non-English speaking, b) have severe vision, hearing impairment precluding study participation, c) no text messaging capability, d) decompensated cirrhosis requiring hospitalization in the past 30 days, e) medication primarily given by a caregiver/facility
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：他の
- 割り当て：ランダム化
- 介入モデル：並列代入
- 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 |
|---|---|
|
他の：Arm 1: Control
MedSignals pill box will be set into "quiet mode" to track patient compliance.
This mode sends daily adherence data to the Way to Health platform each time the participant opens the pill box, however, does not remind the participant to take the medication.
|
Pill box will provide feedback to the study team regarding subjects' compliance and provide reminders depending on Arm.
|
|
実験的：Arm 2: Reminders/Feedback
MedSignals pill box will track patient compliance and the Way to Health platform will allow participants to receive tailored text message reminders to take the medication if in case the interval from last cap opening is >30 hours (greater than 6 hours overdue).
|
Pill box will provide feedback to the study team regarding subjects' compliance and provide reminders depending on Arm.
|
|
実験的：Arm 3: Reminders/Feedback/Incentives
MedSignals pill box will track patient compliance and in addition to reminders with missed doses and weekly adherence feedback, patients in this arm will be eligible to receive a small financial incentive each week they demonstrate perfect >85% adherence.
The weekly adherence feedback message will also alert patients whether they earned the incentive for the past week.
|
Pill box will provide feedback to the study team regarding subjects' compliance and provide reminders depending on Arm.
|
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 |
時間枠 |
|---|---|
|
Pill bottle measured adherence
時間枠：12 weeks of treatment
|
12 weeks of treatment
|
協力者と研究者
捜査官
- 主任研究者：Peter Reese, MD、University of Pennsylvania
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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 (見積もり)
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
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- P30AG034546 (米国 NIH グラント/契約)
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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。