Medication Adherence Enhancement in Heart Transplant Recipients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2009 by Hannover Medical School.
Recruitment status was  Recruiting
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 23, 2014