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Clinical Trials/NCT00843960
NCT00843960UnknownNot Applicable

Medication Adherence Enhancement in Heart Transplant Recipients: a Randomized Clinical Trial

Hannover Medical School2 sites in 1 country150 target enrollmentStarted: February 2009Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Enrollment
150
Locations
2
Primary Endpoint
Occurrence of adverse events (composite endpoint)
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts 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

Outcomes

Primary Outcomes

Occurrence of adverse events (composite endpoint)

Time Frame: at month 60

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Other

Study Sites (2)

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