Medication Adherence Enhancement in Heart Transplant Recipients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2013-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Medication Adherence Self Management Rejection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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1

intervention group

Group Type ACTIVE_COMPARATOR

behavioral adaptation and symptom management

Intervention Type BEHAVIORAL

behavioral adaptation and symptom management

2

control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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behavioral adaptation and symptom management

Intervention Type BEHAVIORAL

Eligibility Criteria

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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