Medication Adherence, Rejection, Self Management
Conditions
Brief summary
Medication-related non-adherence increases the risk of rejections and associated graft loss after solid organ transplantation. A randomized controlled intervention will use adherence enhancing strategies out of a larger sample of 300 heart transplant recipients. Non-Adherence will be assessed by patients' self-report and based on immunosuppression level. All non-adherent patients will be randomly designed to either intervention or control group. Multi-module interventions include patient education, electronic medication event monitoring, and a combined behavior and symptom management. Longitudinal follow-up is envisioned after initial intervention.
Interventions
BEHAVIORALbehavioral adaptation and symptom management
behavioral adaptation and symptom management
Sponsors
German Federal Ministry of Education and Research
Hannover Medical School
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* all eligible patients with follow-up at our outpatient clinic * written informed consent * sufficient German language skills to read and answer a battery of questionnaires * \> 18 years * minimum 6 mts post HTX
Exclusion criteria
* illiteracy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of adverse events (composite endpoint) | at month 60 |
Secondary
| Measure | Time frame |
|---|---|
| Adherence behavior measurement variables from MEMS system | first 3 month |
| Immunosuppression level | Month 3, 12 and 60 |
| All individual components of the composite endpoint occurence of adverse events | at month 60 |
Countries
Germany
Contacts
Primary ContactChristiane Kugler, PhD
Outcome results
None listed