Pre-Transplant Multidisciplinary Assessment on Medication Adherence and Transplant Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 99
- 试验地点
- 4
- 主要终点
- Comparison of mean daily medication adherence between intervention and control groups over 3 months, as measured by MEMS caps.
研究概览
简要总结
Non-adherence with immunosuppressant drugs is a major reason for premature kidney transplant failure. Currently, patient education and compliance aids (e.g bubble packing) are commonly used to assist patients. This is a study involving patients expected to undergo a kidney transplant within 6 months. One group will undergo a one-month formal assessment of adherence before transplantation using mock immunosuppressant medication. Standardized surveys will also be administered to assess risk factors for non-adherence. A plan will be developed for use after the transplant. The other group will undergo usual care. Kidney function and rejection rates will be compared between two groups.
详细描述
Phase I - Control group.
- The standard of care will be provided to the control group pre- and post-transplant. This does not involve any direct pre-transplant assessment of medication adherence or risk factors for non-adherence.
- Tacrolimus capsules (standard of care immunosupression medication) will be dispensed in Medication Event Monitoring System (MEMS) caps for 3 months post-transplant for the purpose of measuring adherence after transplantation.
- Patients will be asked to complete Basel Assessment of Adherence to Immunosuppressive Medication instrument (BAASIS) self-report questionnaire and Long-term Medication Behaviour Self-efficacy self-report Scale at 3 months after transplantation.
Phase II - Interventional Group.
I. Pre-transplant phase:
- Measurement of Adherence to Medications Patients will be given lactose containing white- and yellow-colored gelatin capsules stored in (MEMS®) bottles for a 1-month adherence trial. Yellow-colored gelatin capsules represent tacrolimus 0.5mg capsules while white-colored gelatin capsules represent tacrolimus 1mg capsules. MEMS® is designed to record the date/time of opening and closure of the drug vial. Patients will be asked to take a certain dose and expected to remove the correct number of white and yellow capsules from respective vial at the correct time each day. Phone calls will be made to patients to change the 'dose' at various times throughout the month to mimic the frequent need to make tacrolimus dosing changes early post-transplant. For patients who are lactose intolerance, they will be instructed to remove the correct number of capsules from the vials but there is no need to take the capsules. Pill count and MEMS record will be reviewed at the end of the 1-month trial period to assess adherence.
- Health literacy: Assessments to completed by the participant:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Kidney transplant candidates anticipated to undergo transplantation from a deceased or living donor within 6 months of enrolment
排除标准
- •There are no exclusion criteria. All eligible patients will be approached by a research assistant. Patients with limited English language fluency will be asked to participate with the assistance of a translator.
结局指标
主要结局
Comparison of mean daily medication adherence between intervention and control groups over 3 months, as measured by MEMS caps.
时间窗: 3 month duration
Adherence is defined as patient opening the MEMS caps within 1 hour of dosing times (ie no missed doses AND ≤ 1-hour variations to scheduled dosing times). Assumption will be made that patient has taken the correct tacrolimus dose if he or she opens MEMS caps within predefined dosing times. Using the MEMS recorded electronic dosing history, a daily binary adherence rate will be calculated per patient (ie day with correct dosing and/or timing). It is recognized that adherence rate may wane over time post-transplant. A 3-month duration is chosen for the primary outcome for logistical reasons since out-of-town patients are usually transferred back to a peripheral transplant center closer to home at this time. A pilot will be conducted for 40 local transplant recipients (20 each in control and interventional groups) to extend the use of MEMS for 6 months to capture any differences in adherence rates beyond three months.
次要结局
- Patient survival(12 months)
- Medication Behaviour for intervention group only(3 months)
- Montreal Cognitive Assessment for intervention group only(3 months)
- Self-reported adherence rates as measured by BAASIS(3-12 months)
- Biopsy proven acute rejection (BPAR) rate(12 months)
- Proportion of patients within target tacrolimus trough levels(3-12 months)
- Comparison of post-transplant test results between intervention and control group(3 months)
- Staff resource utilization(Through study completion, an average of 1 year)
- Kidney allograft function(12 months)
- Kidney allograft survival(12 months)
- The coefficient of variation (CV) of tacrolimus trough levels(3-12 months)
- Medication nonadherence-related hospital readmissions(12 months)
- Health Literacy for intervention group only(3 months)
研究者
John Gill
Professor of Medicine, Division of Nephrology, Principal Investigator
University of British Columbia