Medication Adherence Enhancement in Heart Transplant Recipients
1 other identifier
interventional
150
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2009
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 12, 2009
CompletedFirst Posted
Study publicly available on registry
February 13, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedOctober 7, 2009
October 1, 2009
11 months
February 12, 2009
October 6, 2009
Conditions
Outcome Measures
Primary Outcomes (1)
Occurrence of adverse events (composite endpoint)
at month 60
Secondary Outcomes (5)
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
Immunosuppression level
month 12
Immunosuppression level
at month 60
Study Arms (2)
1
ACTIVE COMPARATORintervention group
2
NO INTERVENTIONcontrol group
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- illiteracy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinic for Cardiac, Thoracic, Transplantation and Vascular Surgery
Hanover, 30625, Germany
Related Publications (1)
Mellon L, Doyle F, Hickey A, Ward KD, de Freitas DG, McCormick PA, O'Connell O, Conlon P. Interventions for increasing immunosuppressant medication adherence in solid organ transplant recipients. Cochrane Database Syst Rev. 2022 Sep 12;9(9):CD012854. doi: 10.1002/14651858.CD012854.pub2.
PMID: 36094829DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christiane Kugler, PhD
Clinic for Cardiac, Thoracic, Transplantation and Vascular Surgery
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 12, 2009
First Posted
February 13, 2009
Study Start
February 1, 2009
Primary Completion
January 1, 2010
Study Completion
December 1, 2013
Last Updated
October 7, 2009
Record last verified: 2009-10