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临床试验/NCT02681770
NCT02681770Unknown不适用

Individual and Dyadic Functioning of Patients and Their Spouses After Kidney Transplantation With Regard to Adherence and Quality of Life

Hannover Medical School0 个研究点目标入组 30 人开始时间: 2016年8月最近更新:
适应症

试验速览

阶段
不适用
入组人数
30
主要终点
levels of adherence (externally evaluated and self-reported, both via questionnaires)

研究概览

简要总结

Following solid organ transplantation, adherence to treatment regime (especially with regard to a reliable intake of immunosuppressant medication) is crucial for transplant survival, and has an impact on the patients' health and morbidity. Approximately 35 % of graft rejection or failure cases in kidney transplant patients are due to insufficient levels of adherence or non-adherence to immunosuppressant medication. Adherence is influenced by both individual and interpersonal aspects in complex interaction.

This study aims at investigating individual and dyadic functioning of both patients and their spouses following kidney transplantation. Outcome measures of interest are patient's level of adherence and both patient and spouse's subjective quality of life.

详细描述

In Germany, kidney transplant patients form the largest group in solid organ transplantation. Improvements in diagnosing and treating medical problems and complications have lead to enhanced survival rates after transplantation. A crucial factor for the long-term success of kidney transplantations is the patients' life-long adherence to immunosuppressant medication. Numerous aspects influencing adherence have been investigated empirically. Across studies, social support has been shown to have an important impact on levels of patients' adherence to treatment. In kidney patients, lower levels of social support have been found to be a risk factor for non-adherence to immunosuppressant therapy, and impaired integration of the transplantation.

From other long-term and potentially life-threatening medical conditions such as breast cancer, the patients' husbands/wives, or spouses are often the primary source of (social) support and of central importance with regard to treatment-related decisions. Thus, spouses are important agents in the course of treatment but are also under considerable (additional) strain. Most studies on psychosocial outcomes of organ transplantation have focused on either patients or spouses. However, medical, social, and psychological aspects influence transplantation outcomes and patients' as well as spouses functioning in complex interaction and should be investigated accordingly.

The study at hand aims at investigating the nature of marital / relationship quality and communication, social support behaviors, emotional arousal, and psychological distress in patients and their spouses after kidney transplantation. Additionally, the role of these variables of interest for important post-transplantation outcomes such as the patients' adherence to immunosuppressive medication and quality of life in both patients and spouses will be analyzed.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • kidney transplantation six or more months ago
  • treated with immunosuppressive medication
  • no Episode of acute rejection reported
  • in a Long-term relationship (Duration of 12 or more months)
  • spouse accompanying Patient to transplantation outpatient clinic

排除标准

  • 未提供

结局指标

主要结局

levels of adherence (externally evaluated and self-reported, both via questionnaires)

时间窗: 6 months after kidney transplantation

self-reported (by Patient) and externally evaluated (by spouse) adherence to immunosuppressive medication

次要结局

  • social support behaviors (self-report questionnaires and coding systems)(6 months after kidney transplantation)
  • emotional functioning (self-report questionnaire and physiological assessment)(6 months after kidney transplantation)
  • quality of life (self-report questionnaire)(6 months after kidney transplantation)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Weusthoff, Dr. Sarah

post-doctoral research associate

Hannover Medical School

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