Phase 4
N=154
Self-management of Low Molecular Weight Heparin Therapy
Thromboembolism
Bottom Line
View on ClinicalTrials.gov: NCT00794560 ↗Enrolled (actual)
154
Serious AEs
0.7%
Results posted
Aug 2014
Primary outcome: Primary: Drug Use Problems — 1.25; 0.86; 1.20; 1.17 scores on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- patient education (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University Hospital, Basel, Switzerland
- Primary completion
- Aug 2009
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 |
— | — |
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.
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
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.