BRIGHT: Building Research Initiative Group: Chronic Illness Management and Adherence in Transplantation
Study Details
Study Description
Brief Summary
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.
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Detailed Description
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:
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To describe CIM practice patterns among centres, countries/continents in HTx.
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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.
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To determine which multi-level factors are related to immunosuppressive medication adherence at the different system levels
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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 Design
Outcome Measures
Primary Outcome Measures
- Self-reported non-adherence to immunosuppressive medication [Once]
Participants will be asked about immunosuppressive medication taking during the prior 4 weeks
Secondary Outcome Measures
- Self-reported non-adherence to other medications (excl. immunosuppressive medications) [Once]
Participants will be asked about adherence to other medications (excl. immunosuppressive medications) during the prior 4 weeks
- Self-reported adherence to smoking cessation [Once]
Participants will be asked about current and past smoking
- Self-reported adherence to dietary modifications [once]
Participants will be asked about adherence to dietary recommendations during the past year
- Self-reported alcohol use [Once]
Participants are asked about alcohol intake during the past year
- Self-reported adherence to physical activity [Once]
Participants are asked about their level of physical activity during the past week
- Self-reported adherence to sun protection [Once]
Participants will be asked about the routine use of sun protection measures
- Self-reported adherence to appointment keeping [Once]
Participants will be asked if they kept the last five appointments with the transplant team
Eligibility Criteria
Criteria
Inclusion Criteria:
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Heart transplant patients
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18 years or older at time of inclusion
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Transplanted and followed-up for routine care in a participating transplant center
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First transplant
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Single-organ transplant
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Between 1 and 5 years post-transplant
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Ability to read, understand and sign written informed consent (in Dutch, English, French, German, Spanish, Italian, or Portuguese, depending on the languages spoken within the country where the participating transplant center is located)
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Provided written informed consent
Exclusion Criteria:
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Receiving professional support in medication taking
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Involved in adherence-intervention research or drug trials during the past 6 months
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Hospitals of Leuven | Leuven | Belgium | 3000 |
Sponsors and Collaborators
- University of Basel
- KU Leuven
- University of Missouri, Kansas City
- Universitaire Ziekenhuizen Leuven
- Hospital Universitario À Coruña, Spain
- Azienda Ospedaliero, Universitaria Pisana
- Hannover Medical School
- Johns Hopkins University
- US Department of Veterans Affairs
- George Washington University
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Hopital Louis Pradel
- Hôpital Nord Laennec, France
- Groupe Hospitalier Pitie-Salpetriere
- University Hospital Heidelberg
- University Hospital, Udine, Italy
- University of Bologna
- Hospital de Sant Pau
- Puerta de Hierro University Hospital
- Hospital Universitario La Fe
- Hospital Universitario Reina Sofia de Cordoba
- University Hospital Inselspital, Berne
- University Hospital, Zürich
- Papworth Hospital NHS Foundation Trust
- Freeman Hospital, UK
- Royal Brompton & Harefield NHS Foundation Trust
- Toronto General Hospital
- University of Ottawa Heart Institute, Canada
- St. Paul's Hospital, Canada
- London Health Sciences Centre
- Duke University Hospital, USA
- Virginia Commonwealth University
- The Cleveland Clinic
- Cedars-Sinai Medical Center
- Kaiser Permanente
- St Luke's Hospital, USA
- Hospital of the University of Pennsylvania, USA
- Ochsner Health System
- Hospital Israelita Albert Einstein
- Instituto Dante Pazzanese de Cardiologia
- Instituto do Coração da Universidade de São Paulo, Brazil
- St Vincent's Hospital, Australia
- The Prince Charles Hospital
- Astellas Pharma Europe Ltd., UK
Investigators
- Principal Investigator: Sabina M De Geest, PhD, RN, University of Basel
Study Documents (Full-Text)
None provided.More Information
Publications
- Berben L, Denhaerynck K, Dobbels F, Engberg S, Vanhaecke J, Crespo-Leiro MG, Russell CL, De Geest S; BRIGHT study consortium. Building research initiative group: chronic illness management and adherence in transplantation (BRIGHT) study: study protocol. J Adv Nurs. 2015 Mar;71(3):642-54. doi: 10.1111/jan.12519. Epub 2014 Sep 26.
- Berben L, Russell C, Engberg S, Dobbels F, De Geest S. Development, content validity and inter-rater reliability testing of the Chronic Illness Management Implementation - Building Research Initiative Group: Chronic Illness Management and Adherence in Transplantation: An instrument to assess the level of chronic illness management implemented in solid organ transplant programmes. International Journal of Care Coordination. 2014;17(1-2):59-71.
- BRIGHT