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

Kidney Transplantation Clinical Trial

— IDyAL  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02681770
• Other study ID #: 3003-2016
• Status: Enrolling by invitation
• Phase: N/A
• First received: February 1, 2016
• Last updated: September 13, 2016
• Start date: August 2016
• Est. completion date: September 2017

Study information

• Verified date: September 2016
• Source: Hannover Medical School
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: September 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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:

Study Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Family Characteristics
• Kidney Transplantation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hannover Medical School

References & Publications (5)

DiMatteo MR. Social support and patient adherence to medical treatment: a meta-analysis. Health Psychol. 2004 Mar;23(2):207-18. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	quality of life (self-report questionnaire)	self-reported quality of life in patients and spouses after kidney transplantation	6 months after kidney transplantation	No