Self-management of Low Molecular Weight Heparin Therapy

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT00794560
First received: November 18, 2008
Last updated: November 20, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Thromboembolism
Behavioral: patient education
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Self-management of Heparin Therapy - Drug Use Problems and Compliance With Self-injected Low Molecular Weight Heparin in Ambulatory Care

Resource links provided by NLM:


Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • drug use problems [ Time Frame: During and at the end of therapy ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • compliance [ Time Frame: at the end of therapy ] [ Designated as safety issue: Yes ]
  • patient satisfaction [ Time Frame: at the end of therapy ] [ Designated as safety issue: No ]

Enrollment: 147
Study Start Date: June 2007
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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
No Intervention: clinical setting: standard care
Recruitment of patients in the hospital into the randomized control group (standard care in community pharmacy)
Experimental: daily life setting: intervention
Recruitment of patients in trained community pharmacies into the intervention group. Intervention is done by trained pharmacists.
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
No Intervention: daily life setting: standard care
Recruitment of patients in community pharmacies into control group (standard care in community pharmacy)

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00794560

Locations
Switzerland
University Hospital of Basle, Switzerland
Basle, Switzerland, CH-4031
Canton Hospital Bruderholz, Switzerland
Bruderholz, Switzerland, CH-4101
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Pfizer
Investigators
Principal Investigator: Kurt E. Hersberger, Prof. PhD Pharmaceutical Care Research Group, University of Basle, Switzerland
  More Information

No publications provided

Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT00794560     History of Changes
Other Study ID Numbers: NRA 630 00 23, EKBB 95/07
Study First Received: November 18, 2008
Last Updated: November 20, 2013
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Hospital, Basel, Switzerland:
Heparin, Low-Molecular-Weight
compliance
drug safety
self-administration
ambulatory Care
Pharmaceutical Services

Additional relevant MeSH terms:
Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thrombosis
Heparin
Heparin, Low-Molecular-Weight
Dalteparin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents

ClinicalTrials.gov processed this record on April 15, 2014