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Self-management of Low Molecular Weight Heparin Therapy

NCT00794560 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 154

Last updated 2014-11-18

Study results available
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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.

Conditions

  • Thromboembolism

Interventions

BEHAVIORAL

patient education

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

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • University Hospital, Basel, Switzerland

    lead OTHER

Principal Investigators

  • Kurt E. Hersberger, Prof. PhD · Pharmaceutical Care Research Group, University of Basle, Switzerland

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2009-08-31
Completion
2009-08-31

Countries

  • Switzerland

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00794560 on ClinicalTrials.gov