Way to Cure HCV Adherence (WTC)
Way to Cure: Developing Effective Strategies to Promote Adherence to Hepatitis C Therapy Among Older Adults
研究概览
详细说明
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.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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Pennsylvania
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Philadelphia、Pennsylvania、美国、19104
- University of Pennsylvania
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Philadelphia、Pennsylvania、美国、19104
- Corporal Michael J. Crescenz VA Medical Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
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
学习计划
研究是如何设计的?
设计细节
- 主要用途:其他
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
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其他: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.
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Pill box will provide feedback to the study team regarding subjects' compliance and provide reminders depending on Arm.
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实验性的: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).
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Pill box will provide feedback to the study team regarding subjects' compliance and provide reminders depending on Arm.
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实验性的: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.
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Pill box will provide feedback to the study team regarding subjects' compliance and provide reminders depending on Arm.
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
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Pill bottle measured adherence
大体时间:12 weeks of treatment
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12 weeks of treatment
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合作者和调查者
调查人员
- 首席研究员:Peter Reese, MD、University of Pennsylvania
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
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Haisco Pharmaceutical Group Co., Ltd.完全的
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University Hospital, GrenobleClinical Investigation Centre for Innovative Technology Network完全的
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University Hospital, Caen完全的
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University of Sao Paulo General HospitalInCor Heart Institute; Chinese Academy of Medical Sciences, Fuwai Hospital; Beneficência Portuguesa... 和其他合作者未知
MedSignals Pill Box的临床试验
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Meshalkin Research Institute of Pathology of Circulation未知
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Columbia UniversityNational Heart, Lung, and Blood Institute (NHLBI)完全的