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

NCT01608477 | Unknown

• 1 other identifier: BRIGHT
• Study Type: observational
• Target: 1,365
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Transplantation

Keywords

Heart transplantation; Medication adherence; Behavior system factor

Outcome Measures

Primary Outcomes (1)

• Self-reported non-adherence to immunosuppressive medication

  Participants will be asked about immunosuppressive medication taking during the prior 4 weeks

  Once

Secondary Outcomes (7)

• Self-reported non-adherence to other medications (excl. immunosuppressive medications)

  Once

• Self-reported adherence to smoking cessation

  Once

• Self-reported adherence to dietary modifications

  once

• Self-reported alcohol use

  Once

• Self-reported adherence to physical activity

  Once

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult heart transplant recipients

You may qualify if:

• Heart transplant patients
• 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

You may not qualify if:

• Receiving professional support in medication taking
• Involved in adherence-intervention research or drug trials during the past 6 months

Sponsors & Collaborators

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

Study Sites (1)

University Hospitals of Leuven

Leuven, 3000, Belgium

Location

Related Publications (11)

• 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.

  BACKGROUND

• 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.

  PMID: 25257974 BACKGROUND

• 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 Heart Lung Transplant. 2017 Mar;36(3):272-279. doi: 10.1016/j.healun.2016.08.024. Epub 2016 Sep 13.

  PMID: 27773449 RESULT

• Cajita MI, Baumgartner E, Berben L, Denhaerynck K, Helmy R, Schonfeld 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 - Findings from the International BRIGHT Study. Heart Lung. 2017 Sep-Oct;46(5):351-356. doi: 10.1016/j.hrtlng.2017.05.006. Epub 2017 Jun 16.

  PMID: 28624338 RESULT

• 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 international BRIGHT study. Eur J Cardiovasc Nurs. 2018 Apr 1;17(4):356-367. doi: 10.1177/1474515117747577. Epub 2017 Dec 1.

  PMID: 29231747 RESULT

• 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 Transplant. 2018 Jun;18(6):1447-1460. doi: 10.1111/ajt.14611. Epub 2018 Jan 16.

  PMID: 29205855 RESULT

• Mielke J, Cajita MI, Denhaerynck K, Valenta S, Dobbels F, Russell CL, De Geest S; BRIGHT study team. Trust in the Transplant Team Associated With the Level of Chronic Illness Management-A Secondary Data Analysis of the International BRIGHT Study. Transpl Int. 2024 Mar 11;37:11704. doi: 10.3389/ti.2024.11704. eCollection 2024.

  PMID: 38529215 DERIVED

• Rose Epstein F, Trammell J, Liu CM, Denhaerynck K, Dobbels F, Russell C, De Geest S. A Secondary Analysis from The International BRIGHT Study For Gender Differences In Adherence To Nonpharmacological Health-Related Behaviors After Heart Transplantation. Prog Transplant. 2022 Jun;32(2):138-147. doi: 10.1177/15269248221087435. Epub 2022 Mar 25. No abstract available.

  PMID: 35331039 DERIVED

• Iglesias K, De Geest S, Berben L, Dobbels F, Denhaerynk K, Russell LC, Helmy R, Peytremann-Bridevaux I; BRIGHT study team. Validation of the patient assessment of chronic illness care (PACIC) short form scale in heart transplant recipients: the international cross-sectional bright study. BMC Health Serv Res. 2020 Mar 3;20(1):160. doi: 10.1186/s12913-020-5003-3.

  PMID: 32126998 DERIVED

• Helmy R, Scalso de Almeida S, Denhaerynck K, Berben L, Dobbels F, Russell CL, de Aguiar Roza B, De Geest S; BRIGHT study team. Prevalence of Medication Nonadherence to Co-medication Compared to Immunosuppressants in Heart Transplant Recipients: Findings From the International Cross-sectional BRIGHT Study. Clin Ther. 2019 Jan;41(1):130-136. doi: 10.1016/j.clinthera.2018.11.007. Epub 2018 Dec 24.

  PMID: 30591285 DERIVED

• Helmy R, Duerinckx N, De Geest S, Denhaerynck K, Berben L, Russell CL, Van Cleemput J, Crespo-Leiro MG, Dobbels F; BRIGHT study team. The international prevalence and variability of nonadherence to the nonpharmacologic treatment regimen after heart transplantation: Findings from the cross-sectional BRIGHT study. Clin Transplant. 2018 Jul;32(7):e13280. doi: 10.1111/ctr.13280. Epub 2018 Jun 21.

  PMID: 29754400 DERIVED

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Sabina M De Geest, PhD, RN

  University of Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD, RN, FAAN, FRCN

Study Record Dates

• First Submitted: May 18, 2012
• First Posted: May 31, 2012
• Study Start: March 1, 2012
• Primary Completion: October 1, 2015
• Study Completion: December 1, 2020
• Last Updated: January 25, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)