An Intervention to Improve Adherence to Medications in Adults With Liver Transplants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Medication Level Variability Index (MLVI)
研究概览
简要总结
The purpose of this study is to pilot-test a tailored telemetric intervention to improve adherence to medications in adults who had a liver transplant and are presently non-adherent (as measured by tacrolimus levels).
详细描述
Adult patients who received a liver transplant and for whom there are at least 3 tacrolimus blood levels within the last year are eligible for the study. Patients will be recruited from amongst the roster of liver transplant recipients treated at the Recanati-Miller Transplant Institute at Mount Sinai. The intervention will be pilot-tested on up to 15 non-adherent patients. Patients will be identified using an innovative biomarker for non-adherence-by calculating the degree of fluctuation between individual medication blood levels. The telemetric intervention (administered via telephone, or interactive video chat applications such as FaceTime ® or Skype ®) will enable the intervention team (IT) to address non-adherence from a remote location, using a structured, tailored approach that accommodates specific patient needs. The approach includes a focus on psychological avoidance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •The patient is at least 18 years of age.
- •The patient received a liver transplant at least 2 years prior to initiation of the research protocol.
- •The patient is able to provide consent (i.e. is not encephalopathic or does not have significant cognitive impairment). Consent may be obtained either by phone or in person (following a script) and is documented by the researcher.
- •The patient is prescribed tacrolimus (either brand or generic formulation).
- •The patient is not receiving Hepatitis C treatment during the intervention (given this can affect levels of tacrolimus and adherence behaviors)
- •Thee patient has been seen in the liver transplant clinic at least once in the last two years.
- •The patient's MLVI value was ≥ 2, with at least 3 levels present to make this determination. Only tacrolimus levels drawn in the outpatient setting will be included in SD calculations. Tacrolimus levels in the inpatient setting (i.e. during a hospitalization) will be excluded.
- •The patient speaks English or Spanish at a level that allows him/her to understand the study procedures and consent to the study.
排除标准
- •The patient received a liver transplant less than 2 years prior to enrollment.
- •The patient received a dual transplant (i.e. liver and kidney).
- •The treating physician has instructed the patient not to obtain tacrolimus levels for at least one year in the past year.
- •The patient does not understand the study procedures. This will be verified by asking the patient to repeat the study procedures.
- •The patient is actively psychotic or severely disoriented due to any cause, including hepatic encephalopathy (temporary exclusion) or severe cognitive impairment.
- •The patient is not medically stable or is hospitalized (temporary exclusion until stabilized).
结局指标
主要结局
Medication Level Variability Index (MLVI)
时间窗: up to 1 year
The degree of fluctuation of tacrolimus blood levels (calculated as the standard deviation, SD, of tacrolimus).
次要结局
- Incidence of biopsy-proven rejection(up to 1 year)
- ALT(up to 1 year)
- Incidence of hospitalizations(up to 1 year)