Medication Adherence Enhancement in Heart Transplant Recipients

Hannover Medical School (MHH)

Status: Unknown

Conditions: Medication Adherence; Rejection; Self Management

Treatments: Behavioral: behavioral adaptation and symptom management

Study type: Interventional

Funder types: Other

Identifiers

NCT00843960

IFB-P46-377

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

1

Active Comparator group

Description:

intervention group

Treatment:

Behavioral: behavioral adaptation and symptom management

2

No Intervention group

Description:

control group