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

Heart Transplantation Clinical Trial

— BRIGHT  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01608477
• Other study ID #: BRIGHT
• Status: Active, not recruiting
• Start date: March 2012
• Est. completion date: December 2020

Study information

• Verified date: January 2019
• Source: University of Basel
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1365
• Est. completion date: December 2020
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Heart transplant patients

• 18 years or older at time of inclusion

• Transplanted and followed-up for routine care in a participating transplant center

• First transplant

• Single-organ transplant

• Between 1 and 5 years post-transplant

• 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)

• Provided written informed consent

Exclusion Criteria:

• Receiving professional support in medication taking

• Involved in adherence-intervention research or drug trials during the past 6 months

Related Conditions & MeSH terms

• Chronic Disease
• Heart Transplantation

Locations

Country	Name	City	State
Belgium	University Hospitals of Leuven	Leuven

Sponsors (44)

Lead Sponsor

Collaborator

University of Basel

Astellas Pharma Europe Ltd., UK, Azienda Ospedaliero, Universitaria Pisana, Cedars-Sinai Medical Center, Cliniques universitaires Saint-Luc- Université Catholique de Louvain, Duke University Hospital, USA, Freeman Hospital, UK, George Washington University, Groupe Hospitalier Pitie-Salpetriere, Hannover Medical School, Hopital Louis Pradel, Hôpital Nord Laennec, France, Hospital de Sant Pau, Hospital Israelita Albert Einstein, Hospital of the University of Pennsylvania, USA, Hospital Universitario À Coruña, Spain, Hospital Universitario La Fe, Hospital Universitario Reina Sofia de Cordoba, Instituto Dante Pazzanese de Cardiologia, Instituto do Coração da Universidade de São Paulo, Brazil, Johns Hopkins University, Kaiser Permanente, KU Leuven, London Health Sciences Centre, Ochsner Health System, Papworth Hospital, Puerta de Hierro University Hospital, Royal Brompton & Harefield NHS Foundation Trust, St Luke's Hospital, USA, St Vincent's Hospital, Australia, St. Paul's Hospital, Canada, The Cleveland Clinic, The Prince Charles Hospital, Toronto General Hospital, Universitaire Ziekenhuizen Leuven, University Hospital Heidelberg, University Hospital Inselspital, Berne, University Hospital, Udine, Italy, University Hospital, Zürich, University of Bologna, University of Missouri, Kansas City, University of Ottawa Heart Institute, Canada, US Department of Veterans Affairs, Virginia Commonwealth University

Country where clinical trial is conducted

Belgium, 

References & Publications (6)

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. — View Citation

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.

Cajita MI, Baumgartner E, Berben L, Denhaerynck K, Helmy R, Schönfeld S, Berger G, Vetter C, Dobbels F, Russell CL, De Geest S; BRIGHT Study Team. Heart transplant centers with multidisciplinary team show a higher level of chronic illness management - Fin — View Citation

Cajita MI, Denhaerynck K, Dobbels F, Berben L, Russell CL, Davidson PM, De Geest S; BRIGHT study team. Health literacy in heart transplantation: Prevalence, correlates and associations with health behaviors-Findings from the international BRIGHT study. J — View Citation

Denhaerynck K, Berben L, Dobbels F, Russell CL, Crespo-Leiro MG, Poncelet AJ, De Geest S; BRIGHT study team. Multilevel factors are associated with immunosuppressant nonadherence in heart transplant recipients: The international BRIGHT study. Am J Transpl — View Citation

Senft Y, Kirsch M, Denhaerynck K, Dobbels F, Helmy R, Russell CL, Berben L, De Geest S; BRIGHT study team. Practice patterns to improve pre and post-transplant medication adherence in heart transplant centres: a secondary data analysis of the internationa — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-reported non-adherence to immunosuppressive medication	Participants will be asked about immunosuppressive medication taking during the prior 4 weeks	Once
Secondary	Self-reported non-adherence to other medications (excl. immunosuppressive medications)	Participants will be asked about adherence to other medications (excl. immunosuppressive medications) during the prior 4 weeks	Once
Secondary	Self-reported adherence to smoking cessation	Participants will be asked about current and past smoking	Once
Secondary	Self-reported adherence to dietary modifications	Participants will be asked about adherence to dietary recommendations during the past year	once
Secondary	Self-reported alcohol use	Participants are asked about alcohol intake during the past year	Once
Secondary	Self-reported adherence to physical activity	Participants are asked about their level of physical activity during the past week	Once
Secondary	Self-reported adherence to sun protection	Participants will be asked about the routine use of sun protection measures	Once
Secondary	Self-reported adherence to appointment keeping	Participants will be asked if they kept the last five appointments with the transplant team	Once