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临床试验/NCT01739803
NCT01739803已完成不适用

Behavioral Contract Intervention to Improve Adherence Among Renal Transplant Recipients

University of Tennessee2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2010年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
150
试验地点
2
主要终点
Comparison of Average Immunosuppressant Therapy Adherence for 12-month Study Period

研究概览

简要总结

There is a critical gap in the knowledge on how to implement effective interventions for renal transplant recipients (RTRs) to improve immunosuppressant therapy (IST) adherence and clinical outcomes. The objectives of this project were to address this gap through: (1) designing, implementing, and evaluating a patient-specific behavioral contract intervention to improve RTRs' IST adherence rates (contracts are written, signed agreements between the RTR and healthcare provider in which the RTR agrees to be adherent to IST according to mutually agreed upon criteria); and (2) measuring the effects of IST adherence on RTRs' health-related quality of life (HQoL) and healthcare utilizations and costs. The primary hypothesis was that at one year post trial enrollment, RTRs who establish behavioral contracts with healthcare professionals will be more adherent than those who do not establish behavioral contracts and subsequently will have greater HQoL and lower healthcare utilizations and costs. Once it is better understood how to implement effective IST adherence intervention programs, clinicians will have a valuable tool to promote therapeutic success, improve HQoL, and reduce healthcare utilizations and costs. Therefore, we pursued the following Specific Aims: (1) determine the effectiveness of an IST adherence contract-based intervention on IST adherence; (2) determine the relationship between IST adherence, the intervention, and RTRs' HQoL; and (3) determine the influence of IST adherence and the intervention on RTRs' healthcare utilizations/costs. To achieve the Specific Aims, a randomized controlled trial of the patient-specific behavioral contract-based intervention was conducted, and data regarding adherence, HQoL, and healthcare utilizations/costs were collected over a 12-month period for each RTR study participant and analyzed. This project will promote healthy lives, increase well-being, and reduce burden of illness and disparity among adult RTRs by providing data regarding an adherence intervention and the impact of IST adherence and the behavioral contract intervention on RTRs' health and economic outcomes and HQoL. Collectively, this new knowledge will provide critical steps toward optimizing RTRs' graft maintenance, productivity, and HQoL, while decreasing graft rejection, return to dialysis, morbidity, mortality, and healthcare costs.

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
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • renal transplant recipient
  • at least 21 years of age
  • receive an immunosuppressant regimen that contains oral cyclosporine or tacrolimus
  • be at least one year post-transplant
  • obtain immunosuppressant therapy from Avella Specialty Pharmacy for at least one year prior to study enrollment and during the study period

排除标准

  • institutionalized
  • unable to give informed consent

结局指标

主要结局

Comparison of Average Immunosuppressant Therapy Adherence for 12-month Study Period

时间窗: 12 months

Immunosuppressant therapy adherence as measured by pharmacy refill records. Adherence was calculated quarterly for one year by using the number of days between prescription (IST) refills. If the total number of days between refills was less than or equal to the total days' supply of IST, the participant's adherence rate was 1.0, or 100%. If the number of days between refills was greater than the days' supply, the adherence rate was calculated as follows: 1 - \[(Days Between Refills - Total Days Supply)/Days Between Refills\] = Adherence Rate for Quarterly Time Period At the end of the 12-month study period, the quarterly adherence rates were averaged to produce an overall adherence rate for the study period.

次要结局

  • Health-related Quality of Life (HQoL)(12 months)
  • Days in Hospital(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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