Self-management of Low Molecular Weight Heparin Therapy

Thromboembolism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00794560
• Other study ID #: NRA 630 00 23
• Secondary ID: EKBB 95/07
• Status: Completed
• Phase: Phase 4
• First received: November 18, 2008
• Last updated: November 5, 2014
• Start date: June 2007
• Est. completion date: August 2009

Study information

• Verified date: November 2014
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Thromboembolism

Intervention

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

Locations

Country	Name	City	State
Switzerland	University Hospital of Basle, Switzerland	Basle
Switzerland	Kantonsspital Baselland, Switzerland	Bruderholz

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland	Pfizer

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

Mengiardi S, Tsakiris DA, Molnar V, et al. Impact of Pharmaceutical Care on Self-Administration of Outpatient Low-Molecular-Weight Heparin Therapy. Pharmacology & Pharmacy 5: 372-385, 2014

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Drug Use Problems	During a home visit and at her/his individual injection time, each patient was monitored when self-administering an s.c. injection (directly observed therapy, DOT). Score minimum = -2.00; score maximum = +2.00 for the objective estimation of the application quality. Higher score values represent better outcomes.	during the individual drug therapy, an average of 18 days	Yes
Secondary	Compliance	objectively determined by syringe count Therapy durations varied individually depending on the indication of the drug therapy (days to weeks).	at the end of the individual drug therapy, an average of 18 days	Yes
Secondary	Patient Satisfaction		at the end of the individual drug therapy, an average of 18 days	No