Individual and Dyadic Functioning, Adherence, and Quality of Life After Kidney Transplantation

• Conditions: Kidney Transplantation; Family Characteristics

• Registration Number: NCT02681770
• Lead Sponsor: Hannover Medical School

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2016-02-01
• Study First Submitted QC: 2016-02-11
• Study First Posted: 2016-02-12
• Study Start: 2016-08
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-13
• Last Update Posted: 2016-09-14
• Primary Completion: 2017-03
• Study Completion: 2017-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 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

Exclusion Criteria

• none

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
levels of adherence (externally evaluated and self-reported, both via questionnaires)	6 months after kidney transplantation	self-reported (by Patient) and externally evaluated (by spouse) adherence to immunosuppressive medication

Secondary Outcome Measures

Name	Time	Method
social support behaviors (self-report questionnaires and coding systems)	6 months after kidney transplantation	self-reported and observed communication behavior and self-rated marital quality
emotional functioning (self-report questionnaire and physiological assessment)	6 months after kidney transplantation	self-reported and objectively assessed levels of Emotion regulation and emotional arousal in patients and spouses during social Support interactions with each other after kidney transplantation
quality of life (self-report questionnaire)	6 months after kidney transplantation	self-reported quality of life in patients and spouses after kidney transplantation