Phase 4 Completed N=154 Randomized Supportive Care

Self-management of Low Molecular Weight Heparin Therapy

Thromboembolism

Source: ClinicalTrials.gov NCT00794560 ↗

Enrolled (actual)

154

Serious AEs

0.7%

Results posted

Aug 2014

Primary outcomePrimary: Drug Use Problems — 1.25; 0.86; 1.20; 1.17 scores on a scale

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Drug Use Problems	1.25; 0.86; 1.20; 1.17	—
SECONDARY Compliance	94.5; 96.2; 95.1; 97.5	—
SECONDARY Patient Satisfaction	—	—

Eligibility Criteria

Inclusion Criteria

Patients are recruited from orthopedic clinics, an emergency department and from community pharmacies with a prescription for a LMWH as an outpatient treatment.
self-application of the LMWH
german / english speaking

-> clinical setting:

Dalteparin

-> daily life setting:

all LMWH (ready-to-use syringes)
control group: self-application or application by another person (family member, medical person, etc.)

Exclusion Criteria

patient's home far away from study center

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00794560). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.