NCT02681770

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2016

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 12, 2016

Completed
6 months until next milestone

Study Start

First participant enrolled

August 1, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

September 14, 2016

Status Verified

September 1, 2016

Enrollment Period

7 months

First QC Date

February 1, 2016

Last Update Submit

September 13, 2016

Conditions

Kidney TransplantationFamily Characteristics

Keywords

kidney transplantationadherencequality of lifecouplesfundamental frequencycommunicationsocial support

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

    PMID: 24950938BACKGROUND

  • 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.

    PMID: 15008666BACKGROUND

  • 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.

    PMID: 11392915BACKGROUND

  • 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.

    PMID: 26526310BACKGROUND

  • 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.

    PMID: 27274840BACKGROUND

MeSH Terms

Conditions

Communication

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Tanja Zimmermann, Professor

    Hannover Medical School

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
post-doctoral research associate

Study Record Dates

First Submitted

February 1, 2016

First Posted

February 12, 2016

Study Start

August 1, 2016

Primary Completion

March 1, 2017

Study Completion

September 1, 2017

Last Updated

September 14, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share