Effectiveness of a Novel Smart Tag Technology in a Pharmacy-Led Setting to Improve Adherence, Patient-Centered Care and Outcomes in HCV
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Medication adherence
研究概览
简要总结
The goal of this non-inferiority clinical trial is to evaluate the efficacy of Tappt, a novel digital medication companion solution, among individuals with hepatitis C virus (HCV) who are starting a daily oral medication regimen following standard of care in a clinical pharmacy setting.
- The primary aim is to assess the non-inferiority of Tappt with medication adherence, treatment completion, sustained virologic response (SVR) assessment, and SVR achievement rates.
- The secondary aim is to assess the efficacy of Tappt at enabling pharmacists to personalize treatment and management decision based on participants' reported barriers to adherence, care, and SVR achievement.
Participants will download and utilize the Tappt app to record adherence to oral medication. For the purposes of this study, adherence for participants in the intervention arm will be measured using a modified medication possession ratio (MPR) measure called medication tag scan ratio (MTSR). MTSR is defined as a percentage of the number of times participants scanned their passive tags versus the total of expected tag scans based on that participant's medication regimen and treatment period.
Upon study completion, a retrospective matched control will be established for the intervention group. Historic data for the matched control's adherence, treatment completion, SVR assessment, and SVR rates will be compared to the intervention arm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •Hepatitis C virus (HCV) infection (denoted by positive HCV antibody and detectable HCV RNA)
- •Initiating oral HCV therapy with glecaprevir/pibrentasvir or sofosbuvir/velpatasvir
- •HCV treatment provided and managed by the clinical pharmacist at UI Health
- •Access to a mobile smartphone (iPhone 7 or later; Android release date 2012 or later) with reliable data and/or Wi-Fi access
- •Ability to verbalize understanding of the study protocol in English
- •Able and willing to provide informed consent in English
排除标准
- •Inability to speak and read English
- •Inability or unwillingness to adhere to the study protocol
- •Pregnant individuals
- •Decompensated cirrhosis (Child Turcotte Pugh Class B and C); hepatocellular carcinoma; prior liver or kidney transplant
- •No patient will be excluded because of gender, race or ethnic origin.
- •The following populations will be excluded from the study:
- •Adults 18 years of age and older who are unable or unwilling to consent
- •Individuals less than 18 years old
- •Pregnant individuals
- •Prisoners
研究组 & 干预措施
Tappt App
Participants will download and utilize the Tappt app to record adherence to oral medication. For the purposes of this study, adherence for participants in the intervention arm will be measured using a modified medication possession ratio (MPR) measure called medication tag scan ratio (MTSR). MTSR is defined as a percentage of the number of times participants scanned their passive tags versus the total of expected tag scans based on that participant's medication regimen and treatment period.
干预措施: Use of Tappt App (Other)
Historical Control
Upon study completion, a retrospective matched control will be established for the intervention group. Historic data for the matched control's adherence, treatment completion, SVR assessment, and SVR rates will be compared to the intervention arm.
结局指标
主要结局
Medication adherence
时间窗: 8-12 weeks
Modified medication possession ratio (MPR) measure called medication tag scan ratio (MTSR)
次要结局
未报告次要终点