Heart TransplantationBRIGHTNCT01608477
Building Research Initiative Group: Chronic Illness Management and Adherence in Transplantation
An observational study of Heart Transplantation, run by University of Basel at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Transplantation
- How many people
- 1,365 participants
- Where
- 1 siteBelgium
- Study dates
- Mar 2012to Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult heart transplant recipients
Who may be able to join
- 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
Who cannot join
- Receiving professional support in medication taking
- Involved in adherence-intervention research or drug trials during the past 6 months
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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:
- To describe CIM practice patterns among centres, countries/continents in HTx.
- 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.
- To determine which multi-level factors are related to immunosuppressive medication adherence at the different system levels
- 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.
- Conditions
- Heart Transplantation
- Keywords
- Heart transplantation, Medication adherence, Behavior system factor
- Medical subject headings
- Medication Adherence
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported non-adherence to immunosuppressive medication
Participants will be asked about immunosuppressive medication taking during the prior 4 weeks
Measured: Once
Secondary outcomes (7)
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
Measured: Once
Self-reported adherence to smoking cessation
Participants will be asked about current and past smoking
Measured: Once
Self-reported adherence to dietary modifications
Participants will be asked about adherence to dietary recommendations during the past year
Measured: once
Self-reported alcohol use
Participants are asked about alcohol intake during the past year
Measured: Once
Self-reported adherence to physical activity
Participants are asked about their level of physical activity during the past week
Measured: Once
Self-reported adherence to sun protection
Participants will be asked about the routine use of sun protection measures
Measured: Once
Self-reported adherence to appointment keeping
Participants will be asked if they kept the last five appointments with the transplant team
Measured: Once
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2012 (estimated)
- Study startMar 2012
- Primary completionOct 2015
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Heart TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 1,365 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Basel
- Sponsor type
- University, hospital or other
- Collaborators
- KU Leuven, University of Missouri, Kansas City, Universitaire Ziekenhuizen KU 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, Insel Gruppe AG, University Hospital Bern, 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, Sydney, The Prince Charles Hospital, Astellas Pharma Europe Ltd.
- Responsible party
- Principal investigator, Sabina De Geest, University of Basel
- Investigators
- Sabina M De Geest, PhD, RN, Principal investigator, University of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01608477
- Sponsor's protocol ID
- BRIGHT
- Acronym
- BRIGHT
- Status last verified
- Jan 2019
- First submitted
- 18 May 2012
- Last updated
- 25 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
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.
PubMed 25257974Cajita 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.
PubMed 27773449Cajita 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.
PubMed 28624338Senft 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.
PubMed 29231747Denhaerynck 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.
PubMed 29205855Mielke 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.
PubMed 38529215Rose 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.
PubMed 35331039Iglesias 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.
PubMed 32126998Helmy 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.
PubMed 30591285Helmy 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.
PubMed 29754400
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building Research Initiative Group: Chronic Illness Management and Adherence in Transplantation
- ClinicalTrials.gov ID
- NCT01608477
- Acronym / sponsor ID
- BRIGHT / BRIGHT
- Conditions
- Heart Transplantation
- Keywords
- Heart transplantation, Medication adherence, Behavior system factor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,365 participants (actual)
- Lead sponsor
- University of BaselUniversity, hospital or other
- Collaborators
- KU Leuven, University of Missouri, Kansas City, Universitaire Ziekenhuizen KU 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, Insel Gruppe AG, University Hospital Bern, 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, Sydney, The Prince Charles Hospital, Astellas Pharma Europe Ltd.
- Study start
- Mar 2012 (actual)
- Primary completion
- Oct 2015 (actual)
- Study completion
- Dec 2020 (estimated)
- First posted
- 31 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- To describe CIM practice patterns among centres, countries/continents in HTx.
- 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.
- To determine which multi-level factors are related to immunosuppressive medication adherence at the different system levels
- 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
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult heart transplant recipients
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (2 listed)
- Receiving professional support in medication taking
- Involved in adherence-intervention research or drug trials during the past 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Self-reported non-adherence to immunosuppressive medication
Time frame: Once
Participants will be asked about immunosuppressive medication taking during the prior 4 weeks
7 secondary outcomes
Self-reported non-adherence to other medications (excl. immunosuppressive medications)
Time frame: Once
Self-reported adherence to smoking cessation
Time frame: Once
Self-reported adherence to dietary modifications
Time frame: once
Self-reported alcohol use
Time frame: Once
Self-reported adherence to physical activity
Time frame: Once
Self-reported adherence to sun protection
Time frame: Once
Self-reported adherence to appointment keeping
Time frame: Once
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2019.
- BackgroundBerben 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: PubMed 25257974Berben 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.
- Results publication: PubMed 27773449Cajita 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.
- Results publication: PubMed 28624338Cajita 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.
- Results publication: PubMed 29231747Senft 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.
- Results publication: PubMed 29205855Denhaerynck 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.
- Derived from this study: PubMed 38529215Mielke 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.
- Derived from this study: PubMed 35331039Rose 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.
- Derived from this study: PubMed 32126998Iglesias 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.
- Derived from this study: PubMed 30591285Helmy 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.
- Derived from this study: PubMed 29754400Helmy 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sabina M De Geest, PhD, RN principal investigator
University of Basel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Transplantation, run by University of Basel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported non-adherence to immunosuppressive medication (time frame: Once). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01608477, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2019.