Heart Transplantation Clinical Trial
Official title:
Building Research Initiative Group: Chronic Illness Management and Adherence in Transplantation
Over the past decades, survival rates in heart transplantation recipients improved
significantly, due to advancements in regimens of immunosuppressives and surgical techniques,
but are still limited to the first 12 months post transplantation. Long-term survival remains
almost unchanged indicating the need to identify and improve relevant factors. Evidence in
other chronically-ill patient populations shows that the healthcare system (e.g. level of
chronic illness management (CIM)) and patient self-management (e.g. adherence) drive
improvements in outcomes.
The BRIGHT study is the first multi-centre, multi-continental study examining healthcare
system and heart transplant centres chronic illness management practice patterns and
potential correlates of immunosuppressive medication nonadherence.
The knowledge gained will inform clinicians, researchers and healthcare policy makers about
the level(s) interventions need to be implemented at to improve long-term outcomes for
transplant recipients.
Background: After receiving a heart transplant (HTx) patients have to adhere to a number of
health behaviors (e.g., medication taking, and smoking cessation) in order to guarantee
optimal outcomes. Non-adherence to these health behaviors is associated with poor clinical
and economic outcomes. However, the prevalence of non-adherence to these health behaviors is
high among HTx recipients. Furthermore, differences in prevalences among countries and
continents are observed. The extent to which a HTx recipient is adherent is affected by a
variety of risk factors, namely 1) patient-related factors, 2) socioeconomic factors, 3)
therapy-related factors, 4) health-related factors and 5) healthcare system and team factors.
To-date, this last group of factors only received limited attention in understanding the
complex phenomena of adherence.
Aims: The aims of this study are:
1. To describe CIM practice patterns among centres, countries/continents in HTx.
2. To assess the prevalence and variability of nonadherence to treatment regimen, i.e.
medication taking, smoking cessation, diet keeping, alcohol consumption, physical
activity, sun protection and appointment keeping in HTx recipients among centres,
countries/continents.
3. To determine which multi-level factors are related to immunosuppressive medication
adherence at the different system levels
4. To benchmark the participating centres, countries and continents in relation to CIM
practice patterns and non-adherence to health behaviours
Methodology: The BRIGHT study is an international, multi-center, cross-sectional study. Data
were collected using interviews and questionnaires. HTx recipients, nurses working in the
post-transplantation care of HTx recipients and the medical directors of the HTx programs
were surveyed. The investigators recruited a convenience sample of 36 heart transplantation
centers (North America (n= 12), European (n= 19), Australia (n= 2) and South America (n= 3)).
Within participating centers, a random sample of patients who met the study eligibility
criteria was selected. Per center, a minimum of 20 and a maximum of 60 patients were
included. In total, 1677 heart transplant recipients were invited to participate in this
study. The questionnaires used in this study will be existing questionnaires (e.g. BAASIS
interview to assess adherence with medications, DASS to assess depression) as well as
questionnaires developed for this study.
During a regular follow-up visit, patients were invited by a staff person to participate in
this study. The staff first informed the patient about the study and, if the patient was
willing to participate, retrieved a signed informed consent. Participating in this study was
voluntary. Informed consent of the nurses and the medical director of the transplant center
were implied by completing the questionnaires. Participant names will be held in strict
confidence and will remain anonymous in research reports or publications.
The results of the benchmarking of the parameters assessed in this study will be reported by
figures and tables. Because of privacy, the HTx centers can only identify the parameters
specific to their center. All other information will be reported anonymously.
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