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: August 13, 2014
Last verified: August 2014
  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 the individual drug therapy, an average of 18 days ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • Compliance [ Time Frame: at the end of the individual drug therapy, an average of 18 days ] [ Designated as safety issue: Yes ]
    objectively determined by syringe count Therapy durations varied individually depending on the indication of the drug therapy (days to weeks).

  • Patient Satisfaction [ Time Frame: at the end of the individual drug therapy, an average of 18 days ] [ Designated as safety issue: No ]

Enrollment: 154
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.

Intervention: patient education

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.

Intervention: patient education

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Results First Received: June 4, 2014
Last Updated: August 13, 2014
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 October 19, 2014