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.
調査の概要
詳細な説明
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.
研究の種類
入学 (予想される)
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
levels of adherence (externally evaluated and self-reported, both via questionnaires)
時間枠:6 months after kidney transplantation
|
self-reported (by Patient) and externally evaluated (by spouse) adherence to immunosuppressive medication
|
6 months after kidney transplantation
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
---|---|---|
social support behaviors (self-report questionnaires and coding systems)
時間枠:6 months after kidney transplantation
|
self-reported and observed communication behavior and self-rated marital quality
|
6 months after kidney transplantation
|
emotional functioning (self-report questionnaire and physiological assessment)
時間枠: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
|
6 months after kidney transplantation
|
quality of life (self-report questionnaire)
時間枠:6 months after kidney transplantation
|
self-reported quality of life in patients and spouses after kidney transplantation
|
6 months after kidney transplantation
|
協力者と研究者
スポンサー
捜査官
- スタディディレクター:Tanja Zimmermann, Professor、Hannover Medical School
出版物と役立つリンク
一般刊行物
- 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.
研究記録日
主要日程の研究
研究開始
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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