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Self-management of Low Molecular Weight Heparin Therapy

Information source: University Hospital, Basel, Switzerland
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Thromboembolism

Intervention: patient education (Behavioral)

Phase: Phase 4

Status: Completed

Sponsored by: University Hospital, Basel, Switzerland

Official(s) and/or principal investigator(s):
Kurt E. Hersberger, Prof. PhD, Principal Investigator, Affiliation: Pharmaceutical Care Research Group, University of Basle, Switzerland

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Primary outcome: Drug Use Problems

Secondary outcome:

Compliance

Patient Satisfaction

Detailed description: Patient recruitment in community pharmacies enables the testing of the feasibility of the interventions under daily-practice conditions and facilitates the recruitment of a larger number of patients. Data collection:

- telephone interviews with structured questionnaires at the beginning and at the end of

the therapy

- monitored self-injection in the study center or at patient's home (direct observation

technique [DOT])

- compliance measurement: answers from patient interviews, comparing number of used

syringes vs. number of prescribed syringes (analogue "pill count"), measuring residual volume in recycled syringes

- recording of the fine motor skills by the adapted "Disabilities of the Arm, Shoulder

and Hand" questionnaire (DASH questionnaire)

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

University Hospital of Basle, Switzerland, Basle CH-4031, Switzerland

Kantonsspital Baselland, Switzerland, Bruderholz CH-4101, Switzerland

Additional Information

Starting date: June 2007
Last updated: November 5, 2014

Page last updated: August 20, 2015

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