Self-management of Low Molecular Weight Heparin Therapy

NCT00794560

Last updated date
Study Location
University Hospital of Basle, Switzerland
Basle, , CH-4031, Switzerland
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Thromboembolism
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- patient's home far away from study center

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Advanced Information
Descriptive Information
Brief Title  ICMJE Self-management of Low Molecular Weight Heparin Therapy
Official Title  ICMJE Self-management of Heparin Therapy - Drug Use Problems and Compliance With Self-injected Low Molecular Weight Heparin in Ambulatory Care
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)
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Thromboembolism
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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

    Intervention: Behavioral: patient education
  • 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

    Intervention: Behavioral: patient education
  • No Intervention: daily life setting: standard care
    Recruitment of patients in community pharmacies into control group (standard care in community pharmacy)
Publications * 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 23, 2014)
154
Original Estimated Enrollment  ICMJE
 (submitted: November 19, 2008)
120
Actual Study Completion Date  ICMJE August 2009
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00794560
Other Study ID Numbers  ICMJE NRA 630 00 23
EKBB 95/07 ( Other Identifier: ethics committee )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Basel, Switzerland
Study Sponsor  ICMJE University Hospital, Basel, Switzerland
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Kurt E. Hersberger, Prof. PhDPharmaceutical Care Research Group, University of Basle, Switzerland
PRS Account University Hospital, Basel, Switzerland
Verification Date November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP