Medication Adherence Enhancement in Heart Transplant Recipients

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

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 Overview

• Status: Unknown
• Conditions: Medication Adherence; Rejection; Self Management
• Intervention / Treatment: Behavioral: behavioral adaptation and symptom management

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Hannover, Germany, 30625
    • Recruiting
    • Clinic for Cardiac, Thoracic, Transplantation and Vascular Surgery
    • Contact: Christiane Kugler, PhD; Phone Number: 6586 ++49.511.532.; Email: kugler.christiane@mh-hannover.de
    • Sub-Investigator: Christoph Bara, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1; intervention group	Behavioral: behavioral adaptation and symptom management; behavioral adaptation and symptom management
No Intervention: 2; control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Occurrence of adverse events (composite endpoint)	at month 60

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Hannover Medical School
• Collaborators: German Federal Ministry of Education and Research
• Investigators: Principal Investigator: Christiane Kugler, PhD, Clinic for Cardiac, Thoracic, Transplantation and Vascular Surgery

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Anticipated): January 1, 2010
• Study Completion (Anticipated): December 1, 2013

Study Registration Dates

• First Submitted: February 12, 2009
• First Submitted That Met QC Criteria: February 12, 2009
• First Posted (Estimate): February 13, 2009

Study Record Updates

• Last Update Posted (Estimate): October 7, 2009
• Last Update Submitted That Met QC Criteria: October 6, 2009
• Last Verified: October 1, 2009

More Information

Terms related to this study

• Other Study ID Numbers: IFB-P46-377