Kidney TransplantationIDyALNCT02681770
Individual and Dyadic Functioning, Adherence, and Quality of Life After Kidney Transplantation
An observational study of Kidney Transplantation and Family Characteristics, run by Hannover Medical School.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplantation, Family Characteristics
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to Sep 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients having a kidney transplantation at Hannover Medical School presenting for monthly follow-up appointments at the nephrological transplantation outpatient clinic
Who may be able to join
- 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
Who cannot join
- none
About this study
Official title: 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.
Read the 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.
- Conditions
- Kidney Transplantation, Family Characteristics
- Keywords
- kidney transplantation, adherence, quality of life, couples, fundamental frequency, communication, social support
- Medical subject headings
- Communication
What is being measured
The primary outcome is the main question the study is designed to answer.
levels of adherence (externally evaluated and self-reported, both via questionnaires)
self-reported (by Patient) and externally evaluated (by spouse) adherence to immunosuppressive medication
Measured: 6 months after kidney transplantation
Secondary outcomes (3)
social support behaviors (self-report questionnaires and coding systems)
self-reported and observed communication behavior and self-rated marital quality
Measured: 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
Measured: 6 months after kidney transplantation
quality of life (self-report questionnaire)
self-reported quality of life in patients and spouses after kidney transplantation
Measured: 6 months after kidney transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2016 (estimated)
- Study startAug 2016
- Primary completionMar 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Weusthoff, Dr. Sarah, Hannover Medical School
- Investigators
- Tanja Zimmermann, Professor, Study director, Hannover Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02681770
- Sponsor's protocol ID
- 3003-2016
- Acronym
- IDyAL
- Status last verified
- Sep 2016
- First submitted
- 1 Feb 2016
- Last updated
- 14 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 24950938DiMatteo 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.
PubMed 15008666Northouse 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.
PubMed 11392915Pabst 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.
PubMed 26526310Zimmermann 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.
PubMed 27274840
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individual and Dyadic Functioning of Patients and Their Spouses After Kidney Transplantation With Regard to Adherence and Quality of Life
- ClinicalTrials.gov ID
- NCT02681770
- Acronym / sponsor ID
- IDyAL / 3003-2016
- Conditions
- Kidney Transplantation, Family Characteristics
- Keywords
- kidney transplantation, adherence, quality of life, couples, fundamental frequency, communication, social support
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 12 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients having a kidney transplantation at Hannover Medical School presenting for monthly follow-up appointments at the nephrological transplantation outpatient clinic
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
levels of adherence (externally evaluated and self-reported, both via questionnaires)
Time frame: 6 months after kidney transplantation
self-reported (by Patient) and externally evaluated (by spouse) adherence to immunosuppressive medication
3 secondary outcomes
social support behaviors (self-report questionnaires and coding systems)
Time frame: 6 months after kidney transplantation
emotional functioning (self-report questionnaire and physiological assessment)
Time frame: 6 months after kidney transplantation
quality of life (self-report questionnaire)
Time frame: 6 months after kidney transplantation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2016.
- Background: PubMed 24950938Low 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.
- Background: PubMed 15008666DiMatteo 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.
- Background: PubMed 11392915Northouse 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.
- Background: PubMed 26526310Pabst 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.
- Background: PubMed 27274840Zimmermann 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tanja Zimmermann, Professor study director
Hannover Medical School
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplantation and Family Characteristics, run by Hannover Medical School.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
levels of adherence (externally evaluated and self-reported, both via questionnaires) (time frame: 6 months after kidney transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02681770, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2016.