CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 154 enrolled
Drug / intervention
patient educationbehavioral
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00794560
NCT00794560Phase 4Completed

Self-management of Heparin Therapy - Drug Use Problems and Compliance With Self-injected Low Molecular Weight Heparin in Ambulatory Care

University Hospital, Basel, Switzerland·interventional·Posted Nov 20, 2008·Updated Nov 18, 2014

In Brief

A Phase 4 clinical trial evaluating patient education for Thromboembolism. Completed, enrolled 154 participants across 2 sites.

Detailed Summary

There is very little data available on compliance with self-injected low molecular weight heparins (LMWH), but what there is, definitely shows that compliance represents a significant problem. We therefore aim to a) record drug use problems of patients including compliance, b) develop a "SOP" for first instruction by a pharmacist and for subsequent pharmaceutical care and c) to compare intensive pharmaceutical care (intervention) vs. standard care (control) provided in the pharmacy to patients with a prescription for a LMWH as an outpatient treatment. Hypothesis: Intensive pharmaceutical care in ambulatory patients who self-inject low molecular weight heparins results in improved compliance, more safety and satisfaction as well as in fewer complications.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsThromboembolism
CountriesSwitzerland
CollaboratorsPfizer

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 20, 2008
Enrollment StartJun 1, 2007
Primary CompletionAug 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 17.6 years ago

Interventions

patient educationbehavioral

Possible, individualized interventions: * Improvement of patient's knowledge about medication, therapy and drug application by providing detailed written information material * Providing a complete equipment package for self-injection (disinfection patches, patches, plasters, waste disposal box for used syringes) * Patient training: oral instructions for self-injection (and application, if required), exercising the injection technique on a phantom * First self-injection under control of a specially trained pharmacist