Medication Adherence Enhancement in Heart Transplant Recipients

Not Applicable

• Conditions: Medication Adherence; Self Management; Rejection

• Registration Number: NCT00843960
• Lead Sponsor: Hannover Medical School

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-02-12
• Study First Submitted QC: 2009-02-12
• Study First Posted: 2009-02-13
• Status Verified: 2009-10
• Last Update Submitted: 2009-10-06
• Last Update Posted: 2009-10-07
• Primary Completion: 2010-01
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Occurrence of adverse events (composite endpoint)	at month 60

Secondary Outcome Measures

Name	Time	Method
Adherence behavior measurement variables from MEMS system	first 3 month
Immunosuppression level	at month 60
All individual components of the composite endpoint occurence of adverse events	at month 60

Trial Locations

Locations (1)

Clinic for Cardiac, Thoracic, Transplantation and Vascular Surgery; 🇩🇪 Hannover, Germany