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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01608477
Recruitment Status : Active, not recruiting
First Posted : May 31, 2012
Last Update Posted : June 14, 2017
Information provided by (Responsible Party):

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.

Condition or disease
Heart Transplantation

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:

  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.

Study Design

Study Type : Observational
Actual Enrollment : 1365 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Building Research Initiative Group: Chronic Illness Management and Adherence in Transplantation
Actual Study Start Date : March 2012
Primary Completion Date : October 2015
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  1. Self-reported non-adherence to immunosuppressive medication [ Time Frame: Once ]
    Participants will be asked about immunosuppressive medication taking during the prior 4 weeks

Secondary Outcome Measures :
  1. 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

  2. Self-reported adherence to smoking cessation [ Time Frame: Once ]
    Participants will be asked about current and past smoking

  3. Self-reported adherence to dietary modifications [ Time Frame: once ]
    Participants will be asked about adherence to dietary recommendations during the past year

  4. Self-reported alcohol use [ Time Frame: Once ]
    Participants are asked about alcohol intake during the past year

  5. Self-reported adherence to physical activity [ Time Frame: Once ]
    Participants are asked about their level of physical activity during the past week

  6. Self-reported adherence to sun protection [ Time Frame: Once ]
    Participants will be asked about the routine use of sun protection measures

  7. Self-reported adherence to appointment keeping [ Time Frame: Once ]
    Participants will be asked if they kept the last five appointments with the transplant team

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult heart transplant recipients

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
Contacts and Locations

Information from the National Library of Medicine

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
Sponsors and Collaborators
University of Basel
KU Leuven, Belgium
University of Missouri, Kansas City
Universitaire Ziekenhuizen Leuven
Hospital Universitario À Coruña, Spain
Azienda Ospedaliero, Universitaria Pisana
Hannover Medical School
Johns Hopkins University
U.S. Department of Veterans Affairs, USA
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
University Hospital Inselspital, Berne
University Hospital, Zürich
Papworth Hospital
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 Santa Clara Medical Center, USA
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
Principal Investigator: Sabina M De Geest, PhD, RN University of Basel
More Information

Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Building research initiative group: chronic illness management and adherence in transplantation (BRIGHT) study: study protocol

Responsible Party: Sabina De Geest, PhD, RN, FAAN, FRCN, University of Basel
ClinicalTrials.gov Identifier: NCT01608477     History of Changes
Other Study ID Numbers: BRIGHT
First Posted: May 31, 2012    Key Record Dates
Last Update Posted: June 14, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sabina De Geest, University of Basel:
Heart transplantation
Medication adherence
Behavior system factor

Additional relevant MeSH terms:
Chronic Disease
Disease Attributes
Pathologic Processes