Trial record 8 of 103 for:    heart transplant OR cardiac transplant | Open Studies | NIH, U.S. Fed

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by University of Basel.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Katholieke Universiteit Leuven
University of Missouri-Columbia
Universitaire Ziekenhuizen Leuven
Hospital Universitario A Coruna Spain
University of Sydney
Azienda Ospedaliero, Universitaria Pisana
Hannover Medical School
Medical University of Vienna
Information provided by (Responsible Party):
Sabina De Geest, University of Basel
ClinicalTrials.gov Identifier:
NCT01608477
First received: May 18, 2012
Last updated: May 28, 2012
Last verified: May 2012
  Purpose

Background: After receiving a heart transplant (HTx) patients have to adhere to a number of health behaviors 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 (patient related, socioeconomic, therapy related, health related and healthcare system and -team related 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 assess the prevalence and variability of adherence with the different health behaviors; 2) to examine the relationship between patient- and healthcare system related factors, and self-reported adherence with immunosuppressive medications, and 3) benchmarking of the participating centers, countries and continents in relation to the parameters assessed in this study.

Methodology: The BRIGHT study is an international, multi-center, cross-sectional study. Data will be collected using interviews and/or questionnaires. HTx recipients, nurses working in the post-transplant care of HTx recipients and the medical director of the HTx program will be surveyed.


Condition
Heart Transplant

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Building Research Initiative Group: Chronic Illness Management and Adherence in Transplantation

Resource links provided by NLM:


Further study details as provided by University of Basel:

Primary Outcome Measures:
  • Self-reported non-adherence to immununosuppressive medication [ Time Frame: Once ] [ Designated as safety issue: No ]
    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) [ Time Frame: Once ] [ Designated as safety issue: No ]
    Participants will be asked about adherence to other medications (excl. immunosuppressive medications)during the prior 4 weeks

  • Self-reported adherence to smoking cessation [ Time Frame: Once ] [ Designated as safety issue: No ]
    Participants will be asked about current and past smoking

  • Self-reported adherence to dietary modifications [ Time Frame: once ] [ Designated as safety issue: No ]
    Participants will be asked about adherence to dietary recommendations during the past year

  • Self-reported alcohol use [ Time Frame: Once ] [ Designated as safety issue: No ]
    Participants are asked about alcohol intake during the past year

  • Self-reported adherence to physical activity [ Time Frame: Once ] [ Designated as safety issue: No ]
    Participants are asked about their level of physical activity during the past week

  • Self-reported adherence to sun protection [ Time Frame: Once ] [ Designated as safety issue: No ]
    Participants will be asked about the routine use of sun protection measures

  • Self-reported adherence to appointment keeping [ Time Frame: Once ] [ Designated as safety issue: No ]
    Participants will be asked if they kept the last five appointments with the transplant team


Estimated Enrollment: 1800
Study Start Date: April 2012
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
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) health care system and -team related 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 assess the prevalence and variability of adherence with the different health behaviors; 2) to examine the relationship between patient- and health care system related factors, and self-reported adherence with immunosuppressive medications, and 3) benchmarking of the participating centers, countries and continents in relation to the parameters assessed in this study.

Methodology: The BRIGHT study is an international, multi-center, cross-sectional study. Data will be collected using interviews and/or questionnaires. HTx recipients, nurses working in the post-transplant care of HTx recipients and the medical director of the HTx program will be surveyed. The investigators will recruit a convenience sample of 46 North American (n= 20), European (n= 20), Australian (n= 3) and South American (n= 3) HTx centers. Following European centers will be included in this study: Austria, Belgium, France, Germany, Italy, Spain, and the UK. Within participating centers a random sample of patients who meet study criteria will be selected. Per center a minimum of 20 and a maximum of 60 patients will be included. In total 1800 heart transplant recipients will be 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 will be invited by a staff person to participate in this study. The staff will first inform the patient about the study and will, if the patient is willing to participate, retrieve signed informed consent. Participating in this study is voluntary. Informed consent of the nurses and the medical director of the transplant center will be implied by completing the questionnaire. 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Adult heart transplant recipients

Criteria

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
  • Independent management of medication taking
  • 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:

  • Professional support in medication taking
  • involved in adherence-intervention research or drug trials during the past 6 months
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01608477

Contacts
Contact: Lut Berben, PhD, RN ++41612670920 lut.berben@unibas.ch

Locations
Belgium
University Hospitals of Leuven Recruiting
Leuven, Belgium, 3000
Sub-Investigator: Johan Vanhaecke, MD, PhD         
Sponsors and Collaborators
University of Basel
Katholieke Universiteit Leuven
University of Missouri-Columbia
Universitaire Ziekenhuizen Leuven
Hospital Universitario A Coruna Spain
University of Sydney
Azienda Ospedaliero, Universitaria Pisana
Hannover Medical School
Medical University of Vienna
Investigators
Principal Investigator: Sabina M De Geest, PhD, RN University of Basel
  More Information

No publications provided

Responsible Party: Sabina De Geest, PhD, RN, FAAN, FRCN, University of Basel
ClinicalTrials.gov Identifier: NCT01608477     History of Changes
Other Study ID Numbers: BRIGHT
Study First Received: May 18, 2012
Last Updated: May 28, 2012
Health Authority: Belgium: Ethics Committee

Keywords provided by University of Basel:
heart transplantation
adherence
behavior system factor

Additional relevant MeSH terms:
Chronic Disease
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on July 24, 2014