Building Research Initiative Group: Chronic Illness Management and Adherence in Transplantation (BRIGHT)
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|ClinicalTrials.gov Identifier: NCT01608477|
Recruitment Status : Unknown
Verified January 2019 by Sabina De Geest, University of Basel.
Recruitment status was: Active, not recruiting
First Posted : May 31, 2012
Last Update Posted : January 25, 2019
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.
|Condition or disease|
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:
- To describe CIM practice patterns among centres, countries/continents in HTx.
- 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.
- To determine which multi-level factors are related to immunosuppressive medication adherence at the different system levels
- 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.
|Study Type :||Observational|
|Actual Enrollment :||1365 participants|
|Official Title:||Building Research Initiative Group: Chronic Illness Management and Adherence in Transplantation|
|Actual Study Start Date :||March 2012|
|Actual Primary Completion Date :||October 2015|
|Estimated Study Completion Date :||December 2020|
- Self-reported non-adherence to immunosuppressive medication [ Time Frame: Once ]Participants will be asked about immunosuppressive medication taking during the prior 4 weeks
- Self-reported non-adherence to other medications (excl. immunosuppressive medications) [ Time Frame: Once ]Participants will be asked about adherence to other medications (excl. immunosuppressive medications) during the prior 4 weeks
- Self-reported adherence to smoking cessation [ Time Frame: Once ]Participants will be asked about current and past smoking
- Self-reported adherence to dietary modifications [ Time Frame: once ]Participants will be asked about adherence to dietary recommendations during the past year
- Self-reported alcohol use [ Time Frame: Once ]Participants are asked about alcohol intake during the past year
- Self-reported adherence to physical activity [ Time Frame: Once ]Participants are asked about their level of physical activity during the past week
- Self-reported adherence to sun protection [ Time Frame: Once ]Participants will be asked about the routine use of sun protection measures
- Self-reported adherence to appointment keeping [ Time Frame: Once ]Participants will be asked if they kept the last five appointments with the transplant team
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01608477
|University Hospitals of Leuven|
|Leuven, Belgium, 3000|
|Principal Investigator:||Sabina M De Geest, PhD, RN||University of Basel|