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Self-management of Low Molecular Weight Heparin Therapy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00794560
First Posted: November 20, 2008
Last Update Posted: November 18, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Pfizer
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland
November 18, 2008
November 20, 2008
June 4, 2014
August 13, 2014
November 18, 2014
June 2007
August 2009   (Final data collection date for primary outcome measure)
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.
Drug Use Problems [ Time Frame: During and at the end of therapy ]
Complete list of historical versions of study NCT00794560 on ClinicalTrials.gov Archive Site
  • 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).
  • Patient Satisfaction [ Time Frame: at the end of the individual drug therapy, an average of 18 days ]
  • Compliance [ Time Frame: at the end of therapy ]
  • Patient Satisfaction [ Time Frame: at the end of therapy ]
Not Provided
Not Provided
 
Self-management of Low Molecular Weight Heparin Therapy
Self-management of Heparin Therapy - Drug Use Problems and Compliance With Self-injected Low Molecular Weight Heparin in Ambulatory Care

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.

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)
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Thromboembolism
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
  • 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)
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.
 
Completed
154
August 2009
August 2009   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
 
NCT00794560
NRA 630 00 23
EKBB 95/07 ( Other Identifier: ethics committee )
No
Not Provided
Not Provided
University Hospital, Basel, Switzerland
University Hospital, Basel, Switzerland
Pfizer
Principal Investigator: Kurt E. Hersberger, Prof. PhD Pharmaceutical Care Research Group, University of Basle, Switzerland
University Hospital, Basel, Switzerland
November 2014

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