Medication Adherence Enhancement in Heart Transplant Recipients

Sponsor

Hannover Medical School (Other)

Overall Status

Unknown status

CT.gov ID

NCT00843960

Collaborator

German Federal Ministry of Education and Research (Other)

150

Enrollment

Location

Arms

Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Medication Adherence Self Management Rejection	Behavioral: behavioral adaptation and symptom management	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Study Start Date :

Feb 1, 2009

Anticipated Primary Completion Date :

Jan 1, 2010

Anticipated Study Completion Date :

Dec 1, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Occurrence of adverse events (composite endpoint) [at month 60]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Clinic for Cardiac, Thoracic, Transplantation and Vascular Surgery	Hannover		Germany	30625

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00843960

Other Study ID Numbers:

IFB-P46-377

First Posted:

Feb 13, 2009

Last Update Posted:

Oct 7, 2009

Last Verified:

Oct 1, 2009

Study Results

No Results Posted as of Oct 7, 2009