Technology Enabled Strategies to Promote Treatment Adherence in Liver Transplant
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 361
- 试验地点
- 6
- 主要终点
- 24 Hour Recall
研究概览
简要总结
Liver transplantation is increasingly performed for older adults with multiple comorbidities. Medication adherence is key to maintaining proper function of the transplanted liver and optimize health; however, adhering to post-transplant treatment is complex. This trial will study how available technology combined with transplant center resources and caregiver support can optimize medication adherence, quality of life, and health outcomes among new liver transplant recipients at 3 centers.
详细描述
Liver transplant, the only cure for end-stage liver disease, is a costly and limited resource that increases survival. It is increasingly performed among older adults who have a higher burden of comorbidities, medical complexity, and are at risk of non-adherence. In addition, liver transplant recipients must manage complex immunosuppression regimens to maintain graft function. Inadequate immunosuppression adherence is common post-liver transplant and has many adverse consequences including liver graft rejection, graft failure, and re-transplantation. To maintain their health, liver transplant recipients must also self-manage regimens for multiple chronic conditions beyond liver transplant.
The TEST Trial intervention is a conceptual framework to address health system and patient level barriers to adherence. By following the Cumulative Complexity Model and the Multiple Chronic Conditions Model, this study focuses on liver transplant recipients and their involved caregivers. The TEST trial leverages the use of electronic health record and Way to Health (W2H) text message system to improve medication adherence.
TEST is a 2-arm, patient-randomized controlled trial at three large, diverse transplant centers: University of Pennsylvania (UPENN), Northwestern University (NU); University of Miami (UM). A total of 360 de novo LTRs age 50 or older (n=180 per arm) within 3 months of transplant will be recruited and randomized to intervention versus usual care for 18 months. Interviews will be conducted at baseline, 6, 12, and 18 months. The TEST intervention includes:
- Monthly W2H Adherence Assessment & Clinician Alerts
- Medication Reminders
- Laboratory and Appointment Notifications
- Supplemental Self-Management Support
The primary objective of the study is to investigate the effectiveness of the TEST Trial to improve adherence to immunosuppressant and non-immunosuppressant medication regimens, functional health status, and health outcomes compared to usual care. Secondary objectives will measure study fidelity and cost effectiveness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- 是
入选标准
- •Liver Transplant Recipient Inclusion Criteria:
- •18 years or older
- •Within 3 months of liver transplant
- •English or Spanish-speaking
- •Home-dwelling*
- •Patient or care partner owns a smart phone and is comfortable receiving text messages and/or using the internet on the smart phone.
- •*The definition of "home" includes hotel or short-term housing. Patients who are going to a rehabilitation or skilled nursing facility (SNF) immediately after transplant may still be recruited if the site-PI/Co-I determines they are likely to be discharged to home within 3 months post-transplant.
- •Care Partner Inclusion Criteria:
- •18 years or older
- •English or Spanish speaking
- •Care partner has access to a smart phone and is comfortable receiving text messages and/or using the internet on the smart phone.
- •Liver Transplant Recipient
排除标准
- •Liver transplant recipient who speaks neither English nor Spanish
- •Any severe uncorrectable vision, hearing, or cognitive impairments that may impede study interviews
- •Care Partner Exclusion Criteria:
- •Care partner who speaks neither English nor Spanish
研究组 & 干预措施
TEST Intervention
Clinical activities for Usual Care will also be provided in the TEST arm. The TEST intervention is a technology-enabled strategy to routinely monitor regimen use, adherence, and persistence via a 'low touch', easy to use, online behavioral toolkit - Way to Health . It was developed by University of Pennsylvania researchers to automate behavioral intervention. The TEST approach includes monthly adherence assessments, with tailored adherence support. The following components will be included in the intervention:
- Monthly W2H Adherence Assessment & Clinician Alerts
- Medication Reminders
- Laboratory and Appointment Notifications
- Supplemental Self-Management Support
干预措施: TEST Intervention (Behavioral)
Usual Care
Usual care refers to the normal standard clinical practices immediately post-transplant to the 18 months following. Liver Transplant Recipients at sites have lab values taken weekly for the first 8-10 weeks post-transplant, shifting to every 2-4 weeks for the next 3-4 months, then monthly to every 3 months thereafter depending on clinical needs.
All sites follow a similar schedule of tapering clinic visits ranging from weekly in the first 4 weeks to every 2-4 weeks in months 4-6, every 3-6 months in months 7 12, and every 6 months in months 12-24. All sites assign each patient to a specific transplant coordinator, first paired with a transplant surgeon (first 3-6 months), and then a transplant hepatologist for the remainder of follow-up.
All patients and caregivers receive standard medication teaching prior to hospital discharge and then ad hoc. No routine text message reminders, caregiver reminders, or adherence alerts are used in usual care.
结局指标
主要结局
24 Hour Recall
时间窗: 18 Months
Patient self-report of how many pills and how often each medicine was taken over the last 24 hours. Patients will also be asked about the medical indication for each drug. Correct dosing will be measured as a yes/no per drug, having properly shown dose (number of pills), spacing (hours between doses), frequency (times per day), and total pills/day.
次要结局
- Liver Graft Outcomes(18 Months)
- EQ-5D-5L(18 Months)
- Post-Transplant Infection(18 Months)
- ASK-12(18 Months)
- Balance Test, seconds(18 Months)
- Liver Frailty Index(18 Months)
- Mortality(18 Months)
- Tacrolimus Lab Values, ng/mL(18 Months)
- Alcohol, Tobacco, and Drugs Survey(18 Months)
- 30-Second Chair Stand, seconds(18 Months)
- Grip Strength, pounds(18 Months)
- Days Alive Out of Hospital(18 Months)