Building Research Initiative Group: Chronic Illness Management and Adherence in Transplantation (BRIGHT)

• Self-reported non-adherence to immununosuppressive medication [ Time Frame: Once ] [ Designated as safety issue: No ]
  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 ] [ Designated as safety issue: No ]
  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 ] [ Designated as safety issue: No ]
  Participants will be asked about current and past smoking
  
  
• Self-reported adherence to dietary modifications [ Time Frame: once ] [ Designated as safety issue: No ]
  Participants will be asked about adherence to dietary recommendations during the past year
  
  
• Self-reported alcohol use [ Time Frame: Once ] [ Designated as safety issue: No ]
  Participants are asked about alcohol intake during the past year
  
  
• Self-reported adherence to physical activity [ Time Frame: Once ] [ Designated as safety issue: No ]
  Participants are asked about their level of physical activity during the past week
  
  
• Self-reported adherence to sun protection [ Time Frame: Once ] [ Designated as safety issue: No ]
  Participants will be asked about the routine use of sun protection measures
  
  
• Self-reported adherence to appointment keeping [ Time Frame: Once ] [ Designated as safety issue: No ]
  Participants will be asked if they kept the last five appointments with the transplant team
  
  

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) health care system and -team related 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 assess the prevalence and variability of adherence with the different health behaviors; 2) to examine the relationship between patient- and health care system related factors, and self-reported adherence with immunosuppressive medications, and 3) benchmarking of the participating centers, countries and continents in relation to the parameters assessed in this study.

Methodology: The BRIGHT study is an international, multi-center, cross-sectional study. Data will be collected using interviews and/or questionnaires. HTx recipients, nurses working in the post-transplant care of HTx recipients and the medical director of the HTx program will be surveyed. The investigators will recruit a convenience sample of 46 North American (n= 20), European (n= 20), Australian (n= 3) and South American (n= 3) HTx centers. Following European centers will be included in this study: Austria, Belgium, France, Germany, Italy, Spain, and the UK. Within participating centers a random sample of patients who meet study criteria will be selected. Per center a minimum of 20 and a maximum of 60 patients will be included. In total 1800 heart transplant recipients will be 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 will be invited by a staff person to participate in this study. The staff will first inform the patient about the study and will, if the patient is willing to participate, retrieve signed informed consent. Participating in this study is voluntary. Informed consent of the nurses and the medical director of the transplant center will be implied by completing the questionnaire. 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.