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

Overview

Journal BMJ Open

Specialty General Medicine

Date 2020 Oct 9

PMID 33033024

Citations 2

Authors

Marietta Lieb

Michael Weyand

Margot Seidl

Yesim Erim

Affiliations

Soon will be listed here.

Abstract

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.

Citing Articles

Pragmatic solutions to enhance self-management skills in solid organ transplant patients: systematic review and thematic analysis.

Abtahi H, Safdari R, Gholamzadeh M BMC Prim Care. 2022; 23(1):166.

PMID: 35773642 PMC: 9247970. DOI: 10.1186/s12875-022-01766-z.

Adherence to Immunosuppression Medications among Heart Transplant Recipients: Challenges, Opportunities, and Potential Role of Digital Approaches in the COVID-19 Era.

Hussain T, Nassetta K, Badawy S J Cardiovasc Dev Dis. 2021; 8(6).

PMID: 34200823 PMC: 8230436. DOI: 10.3390/jcdd8060068.

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