Introduction: Nonadherence may cause severe health problems in heart transplant (HTx) recipients. Research Questions: The present study aimed to investigate adherence to prescribed medication and recommended lifestyle habits in post-HTx patients and to assess associations between adherence, quality of life (QOL), and psychological well-being. Design: A questionnaire package was sent to all HTx patients from our clinic (n ¼ 858) to answer questions anonymously on medication adherence, dietary recommendations (avoidance of raw animal products and ice cream), pet keeping (risk of zoonosis), anxiety and depression, QOL, and posttraumatic stress disorders. Results: Of the contacted patients, 524 (61%) responded and 505 fulfilled the inclusion criteria (age !18 years and ability to understand German). Of the study participants, 72.4% reported taking their medications very correctly, 72.2% stated consuming alcohol less often than once a week, 58.3% performed physical exercise at least once a week, one-third reported eating nonrecommended foods, 22.1% stated pet keeping, and 4.3% reported smoking. Adherence to prescribed medication was positively associated with age (P < .001) and mental QOL (P ¼ .015) but was unrelated to eating nonrecommended foods (P > .05). Depressiveness correlated inversely with physical QOL (r ¼ À0.232; P < .01) and mental QOL (r ¼ À0.411; P < .01). Stress disorders and minor stressful events were reported by 7.8% and 46.6%, respectively. Stress disorders correlated inversely with mental QOL (r ¼ À0.282; P < .01) and physical QOL (r ¼ À0.422; P < .01). Discussion: Many HTx patients adhere to prescribed medications and health advice. Nevertheless, nonadherence is a problem, especially in younger HTx patients, indicating the need for a nonadherence crisis intervention program for long-term HTx patients.
Disturbances in sexual activity are common in patients with an LVAD and their partners while the patients are on durable long-term support. Counselling on long-term adjustment should provide a platform for information seeking on illness-related changes in the quality of sexual activity.
IntroductionSelf-management (SM) may facilitate patient participation and involvement to become active and knowledgeable partners in the care of complex chronic conditions such as ventricular assist device (VAD) therapy. The ‘SM model for patients on VAD support’ will serve to distinguish between SM components, and will guide the development, implementation and evaluation of an evidence-based curriculum.Methods and analysisThis is a 3-phase, multicentre study. In phase 1, a prevalence study will be performed. Phase 2 aims to develop an evidence-based, interprofessional curriculum for SM support for VAD patients. In phase 3, a non-blinded block-randomised controlled trial (RCT), allocation ratio 1:1, intervention group superiority, with an unblinded multifacetted intervention with assessments before (T1) and after (T2) the intervention, and two follow-up assessments at three (T3), and 12 (T4) months after VAD implantation, will be performed. The curriculum guides the intervention in the RCT. Patient recruitment will consider centre-related volume: power analyses require 384 patients for phase 1, and 142 patients for phase 3.Ethics and disseminationEthical considerations will be continuously taken into account and approved by the institutional review boards. Central ethical review board approval has been obtained by the Albert-Ludwigs University Freiburg. This study will be performed in concordance with the Declaration of Helsinki and the European data protection law. Publications will exclusively report aggregated data and will be distributed in the scientific community, and patient support groups. Report languages will be German and English.Trial registration numbersNCT04234230 and NCT04526964; Pre-results.
Background: Some general hospitals within the German health system provide supportive interventions, psychological as well as spiritual, to their patients. It remains to be proven if these interventions are effective when used in routine clinical practice. Aim: To evaluate the effectiveness of psychological and spiritual interventions on improving recovery following bypass surgery. Methods: The BY.PASS study is a pragmatic, patient preference trial (ISRCTN 07297983). Adult patients scheduled for elective coronary bypass surgery were enrolled. Patients were assigned to study conditions according to their personal preference: preference for psychological interventions, for spiritual interventions or for no intervention. Patients who were open for any kind of intervention were randomly assigned either to psychological or spiritual interventions. During a control period, patients were asked about their preference, but did not receive any interventions. Primary outcomes of the study were in-hospital morbidity and early mortality. Psychological measures served as secondary outcomes. Results: A total of 847 patients were enrolled. Patients of the control (n = 260) and the intervention group (n = 269) who explicitly wanted to have interventions were compared. No significant treatment effects either for morbidity (d = 0.08, 95% CI –0.09 to 0.25), or for mortality (OR = 1.81; 95% CI 0.50–6.57) could be found. A reduction of negative mood resulted from both interventions. Conclusions: Although the effects observed were small, the study can serve as a basis to discuss methodological as well as theoretical aspects of a pragmatic trial, based upon patients’ preferences.
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