Self-management of Low Molecular Weight Heparin Therapy

NCT ID: NCT00794560

Last Updated: 2014-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 154 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2009-08-31

Brief 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.

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)

Conditions

Thromboembolism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

clinical setting: intervention

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

Group Type: EXPERIMENTAL

patient education

Intervention Type: BEHAVIORAL

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

clinical setting: standard care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

daily life setting: intervention

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

Intervention: patient education

Group Type: EXPERIMENTAL

patient education

Intervention Type: BEHAVIORAL

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

daily life setting: standard care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kurt E. Hersberger, Prof. PhD

Role: PRINCIPAL_INVESTIGATOR

Pharmaceutical Care Research Group, University of Basle, Switzerland

Locations

University Hospital of Basle, Switzerland

Basel, , Switzerland

Kantonsspital Baselland, Switzerland

Bruderholz, , Switzerland

Countries

Switzerland

References

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

Reference Type: RESULT

Other Identifiers

EKBB 95/07

Identifier Type: OTHER

Identifier Source: secondary_id

NRA 630 00 23

Identifier Type: -

Identifier Source: org_study_id