Prospective single-centre clinical observational study on electronically monitored medication non-adherence, its psychosocial risk factors and lifestyle behaviours after heart transplantation: a study protocol
Introduction In heart transplant recipients (HTRs), non-adherence (NA) to immunosuppressive (IS) medication and to recommended lifestyle behaviours are a common phenomenon and associated with higher risk of allograft rejection, organ loss and mortality. Risk factors for NA are highly diverse and sti...
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BMJ Publishing Group
2020-10-01
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| Series: | BMJ Open |
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| author | Marietta Lieb Michael Weyand Margot Seidl Yesim Erim |
| author_facet | Marietta Lieb Michael Weyand Margot Seidl Yesim Erim |
| author_sort | Marietta Lieb |
| collection | DOAJ |
| description | Introduction In heart transplant recipients (HTRs), non-adherence (NA) to immunosuppressive (IS) medication and to recommended lifestyle behaviours are a common phenomenon and associated with higher risk of allograft rejection, organ loss and mortality. Risk factors for NA are highly diverse and still insufficiently researched. Precise measures of NA and an accurate understanding of its aetiology are of undisputable importance to detect patients at risk and intervene accordingly. The aim of this study is to assess the accuracy and concordance of different measures for NA as well as to determine potential risk factors.Methods and analysis This is a single-centre prospective observational trial. HTRs who are at least aged 18 are no less than 6 months post-transplant and receive tacrolimus (Prograf or Advagraf), cyclosporine (Sandimmun) or everolimus (Certican) as their prescribed IS medication are eligible for participation. We only include patients during the phase of medication implementation. At study enrolment, we assess depression, health-related quality of life, self-efficacy, social support, attachment, experiences and attitudes towards IS medication, emotional responses after transplantation, satisfaction with information about IS medication and perceptions and beliefs about medications. We further ask patients to rate their lifestyle behaviours concerning alcohol, smoking, diet, physical activity, sun protection and appointment keeping via questionnaires. Three different measurement methods for NA are applied at T0: self-reports, physician’s estimates and IS trough levels. NA is monitored prospectively using an electronic multicompartment pillbox (MEMS, VAICA) over a 3-month period. Meanwhile, participants receive phone calls every second week to obtain additional self-reports, resulting in a total of seven measurement points.Ethics and dissemination The study was approved by the Clinical Ethics Committee of the University Hospital Erlangen (Friedrich-Alexander-University, Erlangen-Nürnberg). Written informed consent is attained from all participants. The results of this study will be published in peer-reviewed journals and presented at conferences.Trial registration number DRKS00020496. |
| format | Article |
| id | doaj-art-8f5555efe1594a14abb590aaf8907d4b |
| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2020-10-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-8f5555efe1594a14abb590aaf8907d4b2025-08-20T02:26:27ZengBMJ Publishing GroupBMJ Open2044-60552020-10-01101010.1136/bmjopen-2020-038637Prospective single-centre clinical observational study on electronically monitored medication non-adherence, its psychosocial risk factors and lifestyle behaviours after heart transplantation: a study protocolMarietta Lieb0Michael Weyand1Margot Seidl2Yesim Erim3Department of Psychosomatic Medicine and Psychotherapy, Friedrich-Alexander University Erlangen-Nürnberg, Erlangen, GermanyDepartment of Cardiac Surgery, University of Erlangen, Erlangen, GermanyDepartment of Cardiac Surgery, University Hospital Erlangen, Erlangen, GermanyDepartment of Psychosomatic Medicine and Psychotherapy, University Hospital of Erlangen, Friedrich-Alexander University Erlangen-Nürnberg (FAU), Erlangen, GermanyIntroduction In heart transplant recipients (HTRs), non-adherence (NA) to immunosuppressive (IS) medication and to recommended lifestyle behaviours are a common phenomenon and associated with higher risk of allograft rejection, organ loss and mortality. Risk factors for NA are highly diverse and still insufficiently researched. Precise measures of NA and an accurate understanding of its aetiology are of undisputable importance to detect patients at risk and intervene accordingly. The aim of this study is to assess the accuracy and concordance of different measures for NA as well as to determine potential risk factors.Methods and analysis This is a single-centre prospective observational trial. HTRs who are at least aged 18 are no less than 6 months post-transplant and receive tacrolimus (Prograf or Advagraf), cyclosporine (Sandimmun) or everolimus (Certican) as their prescribed IS medication are eligible for participation. We only include patients during the phase of medication implementation. At study enrolment, we assess depression, health-related quality of life, self-efficacy, social support, attachment, experiences and attitudes towards IS medication, emotional responses after transplantation, satisfaction with information about IS medication and perceptions and beliefs about medications. We further ask patients to rate their lifestyle behaviours concerning alcohol, smoking, diet, physical activity, sun protection and appointment keeping via questionnaires. Three different measurement methods for NA are applied at T0: self-reports, physician’s estimates and IS trough levels. NA is monitored prospectively using an electronic multicompartment pillbox (MEMS, VAICA) over a 3-month period. Meanwhile, participants receive phone calls every second week to obtain additional self-reports, resulting in a total of seven measurement points.Ethics and dissemination The study was approved by the Clinical Ethics Committee of the University Hospital Erlangen (Friedrich-Alexander-University, Erlangen-Nürnberg). Written informed consent is attained from all participants. The results of this study will be published in peer-reviewed journals and presented at conferences.Trial registration number DRKS00020496.https://bmjopen.bmj.com/content/10/10/e038637.full |
| spellingShingle | Marietta Lieb Michael Weyand Margot Seidl Yesim Erim Prospective single-centre clinical observational study on electronically monitored medication non-adherence, its psychosocial risk factors and lifestyle behaviours after heart transplantation: a study protocol BMJ Open |
| title | Prospective single-centre clinical observational study on electronically monitored medication non-adherence, its psychosocial risk factors and lifestyle behaviours after heart transplantation: a study protocol |
| title_full | Prospective single-centre clinical observational study on electronically monitored medication non-adherence, its psychosocial risk factors and lifestyle behaviours after heart transplantation: a study protocol |
| title_fullStr | Prospective single-centre clinical observational study on electronically monitored medication non-adherence, its psychosocial risk factors and lifestyle behaviours after heart transplantation: a study protocol |
| title_full_unstemmed | Prospective single-centre clinical observational study on electronically monitored medication non-adherence, its psychosocial risk factors and lifestyle behaviours after heart transplantation: a study protocol |
| title_short | Prospective single-centre clinical observational study on electronically monitored medication non-adherence, its psychosocial risk factors and lifestyle behaviours after heart transplantation: a study protocol |
| title_sort | prospective single centre clinical observational study on electronically monitored medication non adherence its psychosocial risk factors and lifestyle behaviours after heart transplantation a study protocol |
| url | https://bmjopen.bmj.com/content/10/10/e038637.full |
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