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Completed

NCT Number: NCT00794560

Self-management of Low Molecular Weight Heparin Therapy

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.

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Key information

Conditions

Thromboembolism Behavior Cardiovascular Diseases Embolism and Thrombosis Health Behavior Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital of Basle, Switzerland, Basel, Switzerland

Loading trial locations.

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patient education

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

Primary outcomes

  1. Drug Use Problems

    Time frame: during the individual drug therapy, an average of 18 days

    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 outcomes

  1. Compliance

    Time frame: at the end of the individual drug therapy, an average of 18 days

    objectively determined by syringe count Therapy durations varied individually depending on the indication of the drug therapy (days to weeks).

  2. Patient Satisfaction

    Time frame: at the end of the individual drug therapy, an average of 18 days

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

  • Pfizer

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Nov 20, 2008
Registry last updated
Nov 18, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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