Medication Adherence Enhancement in Heart Transplant Recipients

Medication Adherence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00843960
• Other study ID #: IFB-P46-377
• Status: Recruiting
• Phase: N/A
• First received: February 12, 2009
• Last updated: October 6, 2009
• Start date: February 2009
• Est. completion date: December 2013

Study information

• Verified date: October 2009
• Source: Hannover Medical School
• Contact: Christiane Kugler, PhD
• Phone: ++49.511.532
• Email: kugler.christiane[@]mh-hannover.de
• Is FDA regulated: No
• Health authority: Germany: Federal Ministry of Education and Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2013
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Medication Adherence
• Rejection
• Self Management

Intervention

Behavioral:
• behavioral adaptation and symptom management
behavioral adaptation and symptom management

Locations

Country	Name	City	State
Germany	Clinic for Cardiac, Thoracic, Transplantation and Vascular Surgery	Hannover

Sponsors (2)

Lead Sponsor	Collaborator
Hannover Medical School	German Federal Ministry of Education and Research

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of adverse events (composite endpoint)		at month 60	No
Secondary	Adherence behavior measurement variables from MEMS system		first 3 month	No
Secondary	Immunosuppression level		Month 3, 12 and 60	No
Secondary	All individual components of the composite endpoint occurence of adverse events		at month 60	No
Secondary	Immunosuppression level		month 12	No
Secondary	Immunosuppression level		at month 60	No