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
Results First Received: June 4, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Supportive Care
Condition: Thromboembolism
Intervention: Behavioral: patient education

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.

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
Clinical Setting: Standard Care Recruitment of patients in the hospital into the randomized control group (standard care in community pharmacy)
Daily Life Setting: Intervention

Recruitment of patients in trained community pharmacies into the intervention group. Intervention is done by trained pharmacists.

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
Daily Life Setting: Standard Care Recruitment of patients in community pharmacies into control group (standard care in community pharmacy)

Participant Flow:   Overall Study
    Clinical Setting: Intervention     Clinical Setting: Standard Care     Daily Life Setting: Intervention     Daily Life Setting: Standard Care  
STARTED     36     36     44     38  
COMPLETED     33     32     40     34  
NOT COMPLETED     3     4     4     4  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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.

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
Clinical Setting: Standard Care Recruitment of patients in the hospital into the randomized control group (standard care in community pharmacy)
Daily Life Setting: Intervention

Recruitment of patients in trained community pharmacies into the intervention group. Intervention is done by trained pharmacists.

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
Daily Life Setting: Standard Care Recruitment of patients in community pharmacies into control group (standard care in community pharmacy)
Total Total of all reporting groups

Baseline Measures
    Clinical Setting: Intervention     Clinical Setting: Standard Care     Daily Life Setting: Intervention     Daily Life Setting: Standard Care     Total  
Number of Participants  
[units: participants]
  33     32     40     34     139  
Age  
[units: years]
Median ( Inter-Quartile Range )
  56  
  ( 34 to 60 )  
  56  
  ( 42 to 66 )  
  51  
  ( 36 to 65 )  
  54  
  ( 43 to 67 )  
  54  
  ( 40 to 65 )  
Gender  
[units: participants]
         
Female     16     19     17     18     70  
Male     17     13     23     16     69  



  Outcome Measures
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1.  Primary:   Drug Use Problems   [ Time Frame: during the individual drug therapy, an average of 18 days ]

2.  Secondary:   Compliance   [ Time Frame: at the end of the individual drug therapy, an average of 18 days ]

3.  Secondary:   Patient Satisfaction   [ Time Frame: at the end of the individual drug therapy, an average of 18 days ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Seraina Mengiardi
Organization: Pharmaceutical Care Research Group, University of Basle, Switzerland
phone: 061 267 15 29 ext 0041
e-mail: seraina.mengiardi@unibas.ch


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