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

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

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.

Study Overview

• Status: Unknown
• Conditions: Kidney Transplantation; Family Characteristics

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 Type: Observational
• Enrollment (Anticipated): 30

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients having a kidney transplantation at Hannover Medical School presenting for monthly follow-up appointments at the nephrological transplantation outpatient clinic

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
social support behaviors (self-report questionnaires and coding systems)	self-reported and observed communication behavior and self-rated marital quality	6 months after kidney transplantation
emotional functioning (self-report questionnaire and physiological assessment)	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	6 months after kidney transplantation
quality of life (self-report questionnaire)	self-reported quality of life in patients and spouses after kidney transplantation	6 months after kidney transplantation

Collaborators and Investigators

• Sponsor: Hannover Medical School
• Investigators: Study Director: Tanja Zimmermann, Professor, Hannover Medical School

Publications and helpful links

General Publications

• DiMatteo MR. Social support and patient adherence to medical treatment: a meta-analysis. Health Psychol. 2004 Mar;23(2):207-18. doi: 10.1037/0278-6133.23.2.207.
• Low JK, Williams A, Manias E, Crawford K. Interventions to improve medication adherence in adult kidney transplant recipients: a systematic review. Nephrol Dial Transplant. 2015 May;30(5):752-61. doi: 10.1093/ndt/gfu204. Epub 2014 Jun 20.
• Northouse L, Templin T, Mood D. Couples' adjustment to breast disease during the first year following diagnosis. J Behav Med. 2001 Apr;24(2):115-36. doi: 10.1023/a:1010772913717.
• Pabst S, Bertram A, Zimmermann T, Schiffer M, de Zwaan M. Physician reported adherence to immunosuppressants in renal transplant patients: Prevalence, agreement, and correlates. J Psychosom Res. 2015 Nov;79(5):364-71. doi: 10.1016/j.jpsychores.2015.09.001. Epub 2015 Sep 18.
• Zimmermann T, Pabst S, Bertram A, Schiffer M, de Zwaan M. Differences in emotional responses in living and deceased donor kidney transplant patients. Clin Kidney J. 2016 Jun;9(3):503-9. doi: 10.1093/ckj/sfw012. Epub 2016 Mar 24.

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (Anticipated): March 1, 2017
• Study Completion (Anticipated): September 1, 2017

Study Registration Dates

• First Submitted: February 1, 2016
• First Submitted That Met QC Criteria: February 11, 2016
• First Posted (Estimate): February 12, 2016

Study Record Updates

• Last Update Posted (Estimate): September 14, 2016
• Last Update Submitted That Met QC Criteria: September 13, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: quality of life; communication; adherence; kidney transplantation; social support; couples; fundamental frequency
• Other Study ID Numbers: 3003-2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO