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Medication Adherence Enhancement in Heart Transplant Recipients

This study is currently recruiting participants.
Verified October 2009 by Hannover Medical School
Sponsor:
Collaborator:
German Federal Ministry of Education and Research
Information provided by:
Hannover Medical School
ClinicalTrials.gov Identifier:
NCT00843960
First received: February 12, 2009
Last updated: October 6, 2009
Last verified: October 2009
History of Changes
  Purpose

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.


Condition Intervention
Medication Adherence
Self Management
Rejection
 Behavioral: behavioral adaptation and symptom management

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Medication Adherence Enhancement in Heart Transplant Recipients: a Randomized Clinical Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hannover Medical School:

Primary Outcome Measures:
  • Occurrence of adverse events (composite endpoint) [ Time Frame: at month 60 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adherence behavior measurement variables from MEMS system [ Time Frame: first 3 month ] [ Designated as safety issue: No ]
  • Immunosuppression level [ Time Frame: Month 3, 12 and 60 ] [ Designated as safety issue: No ]
  • All individual components of the composite endpoint occurence of adverse events [ Time Frame: at month 60 ] [ Designated as safety issue: No ]
  • Immunosuppression level [ Time Frame: month 12 ] [ Designated as safety issue: No ]
  • Immunosuppression level [ Time Frame: at month 60 ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: February 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
intervention group
 Behavioral: behavioral adaptation and symptom management
behavioral adaptation and symptom management
No Intervention: 2
control group

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00843960

Contacts
Contact: Christiane Kugler, PhD ++49.511.532 ext 6586 kugler.christiane@mh-hannover.de

Locations
Germany
Clinic for Cardiac, Thoracic, Transplantation and Vascular Surgery Recruiting
Hannover, Germany, 30625
Contact: Christiane Kugler, PhD     ++49.511.532. ext 6586     kugler.christiane@mh-hannover.de    
Sub-Investigator: Christoph Bara, MD            
Sponsors and Collaborators
Hannover Medical School
German Federal Ministry of Education and Research
Investigators
Principal Investigator: Christiane Kugler, PhD Clinic for Cardiac, Thoracic, Transplantation and Vascular Surgery
  More Information

No publications provided

Responsible Party: Dr. rer. biol. hum. Christiane Kugler, Hannover Medical School
ClinicalTrials.gov Identifier: NCT00843960     History of Changes
Other Study ID Numbers: IFB-P46-377
Study First Received: February 12, 2009
Last Updated: October 6, 2009
Health Authority: Germany: Federal Ministry of Education and Research

ClinicalTrials.gov processed this record on May 23, 2013