Self-management of Low Molecular Weight Heparin Therapy

University Hospital Basel

Status and phase: Completed; Phase 4

Conditions: Thromboembolism

Treatments: Behavioral: patient education

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00794560

EKBB 95/07 (Other Identifier)

NRA 630 00 23

Details and patient eligibility

About

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.

Full 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)

Enrollment: 154 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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154 participants in 4 patient groups

clinical setting: intervention

Experimental group

Description:

Recruitment of patients in the hospital into the randomized intervention group. Intervention is done by a trained pharmacist/Doctor of Philosophy-student in the study center (a pharmacy) or at patient's bedside in the hospital. Intervention: patient education

Treatment:

Behavioral: patient education

clinical setting: standard care

No Intervention group

Description:

Recruitment of patients in the hospital into the randomized control group (standard care in community pharmacy)

daily life setting: intervention

Experimental group

Description:

Recruitment of patients in trained community pharmacies into the intervention group. Intervention is done by trained pharmacists. Intervention: patient education

Treatment:

Behavioral: patient education

daily life setting: standard care

No Intervention group

Description:

Recruitment of patients in community pharmacies into control group (standard care in community pharmacy)