A Prospective Single-Center Study on Electronically Monitored Medication Non-Adherence, Psychosocial Risk Factors and Lifestyle Behaviors after Heart Transplantation

A Prospective Single-Center Study on Electronically Monitored Medication Non-Adherence, Psychosocial Risk Factors and Lifestyle Behaviors after Heart Transplantation - APT-Project (Htx)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00020496

Enrollment

Registered

2020-01-22

Start date

2019-08-22

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Z94.1

Interventions

Group 1: At the beginning of the study, the patients' adherence behavior is evaluated with a Variety of measurement Methods. In Addition, psychosocial variables associated with adherence are assessed.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - at least 6 months post-transplant - Tacrolimus, Cyclosporine, or Everolimus as prescribed immunosuppression

Exclusion criteria

Exclusion criteria: - neurocognitive disabilities - insufficient German language skills - severe mental disorders

Design outcomes

Primary

Measure	Time frame
The aim of our study is to investigate electronically monitored non-adherence in heart transplant recipients over a period of 3 months. The following three issues will be addressed: 1)Measurement Methods: Do different measurement methods of NA correlate with each other at the beginning of the study (self-reports, physicians' estimates, trough Levels)? Does electronically monitored NA coincide with self-reported NA during the course of the study? 2)Psychosocial Predictors: Can certain psychosocial factors (depression, health related quality of life, self-efficacy, social support, general approach to close relationships, subjective experiences and attitudes towards immunosuppressive medication, emotional responses after organ transplantation, satisfaction with information about immunosuppressive medication, and perceptions and beliefs about medications) predict electronically monitored NA in HTRs?	—

Measure

Time frame

The aim of our study is to investigate electronically monitored non-adherence in heart transplant recipients over a period of 3 months. The following three issues will be addressed: 1)Measurement Methods: Do different measurement methods of NA correlate with each other at the beginning of the study (self-reports, physicians' estimates, trough Levels)? Does electronically monitored NA coincide with self-reported NA during the course of the study? 2)Psychosocial Predictors: Can certain psychosocial factors (depression, health related quality of life, self-efficacy, social support, general approach to close relationships, subjective experiences and attitudes towards immunosuppressive medication, emotional responses after organ transplantation, satisfaction with information about immunosuppressive medication, and perceptions and beliefs about medications) predict electronically monitored NA in HTRs?

—

Secondary

Measure	Time frame
3) Non-pharmacological adherence and Lifestyle Behaviors: To what extend do heart transplant recipients comply with lifestyle requirements (Smoking, physical activity, sun protection, alcohol use, appointment keeping, diet)? Does immunosuppressive medication coincide with healthy lifestyle behaviors? What are potential risk factors for these behaviors?	—

Countries

Germany

Contacts

Public ContactMarietta Lieb

Universitätsklinikum Erlangen

marietta.lieb@uk-erlangen.de09131-8545930

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 17, 2026