Self-Management of Low Molecular Weight Heparin Therapy - Full Text View

Sponsors and Collaborators:	University Hospital, Basel, Switzerland Pfizer by an "Investigator Initiated Research Grant"
Information provided by:	University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:	NCT00794560

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 IV

MedlinePlus related topics: Blood Thinners

Drug Information available for: Heparin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study
Official Title:	Self-Management of Heparin Therapy - Drug Use Problems and Compliance With Self-Injected Low Molecular Weight Heparin in Ambulatory Care

Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:

drug use problems [ Time Frame: During and at the end of therapy ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

compliance [ Time Frame: at the end of therapy ] [ Designated as safety issue: Yes ]
patient satisfaction [ Time Frame: at the end of therapy ] [ Designated as safety issue: No ]

Estimated Enrollment:	120
Study Start Date:	June 2007
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
clinical setting: intervention: Experimental Recruitment of patients in the hospital into the randomized intervention group. Intervention is done by a trained pharmacist/PhD-student in the study center (a pharmacy) or at patient's bedside in the hospital.	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
clinical setting: standard care: No Intervention Recruitment of patients in the hospital into the randomized control group (standard care in community pharmacy)
daily life setting: intervention: Experimental Recruitment of patients in trained community pharmacies into the intervention group. Intervention is done by trained pharmacists.	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
daily life setting: standard care: No Intervention 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
pregnancy / lactation

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00794560

Contacts

Contact: Seraina Mengiardi, PhD-student	061 267 15 29 ext 0041	seraina.mengiardi@unibas.ch
Contact: Kurt E. Hersberger, PhD	061 267 14 26 ext 0041	kurt.hersberger@unibas.ch

Locations

Switzerland
University Hospital of Basle, Switzerland	Recruiting
Basle, Switzerland, CH-4031
Contact: Dimitrios A Tsakiris, MD, PhD 061 265 25 25 ext 0041 dtsakiris@uhbs.ch
Contact: Seraina Mengiardi, PhD-student 061 267 15 29 ext 0041 seraina.mengiardi@unibas.ch
Principal Investigator: Dimitrios A Tsakiris, MD, PhD
Canton Hospital Bruderholz, Switzerland	Recruiting
Bruderholz, Switzerland, CH-4101
Contact: Urs Kohlhaas-Styk, MD 061 436 36 36 ext 0041 urs.kohlhaas@ksbh.ch
Contact: Seraina Mengiardi, PhD-student 061 267 15 29 ext 0041 seraina.mengiardi@unibas.ch
Principal Investigator: Urs Kohlhaas-Styk, MD

Sponsors and Collaborators

University Hospital, Basel, Switzerland

Pfizer

by an "Investigator Initiated Research Grant"

Investigators

Principal Investigator:

Kurt E. Hersberger, PhD

Institute of Clinical Pharmacy, University of Basle, Switzerland

More Information

Responsible Party:	Institute of Clinical Pharmacy, University of Basle, Switzerland ( Hersberger Kurt E., PhD, Senior Researcher (Privatdozent) )
Study ID Numbers:	NRA 630 00 23, EKBB 95/07
Study First Received:	November 18, 2008
Last Updated:	January 12, 2009
ClinicalTrials.gov Identifier:	NCT00794560
Health Authority:	Switzerland: Ethikkommission

Keywords provided by University Hospital, Basel, Switzerland:

Heparin, Low-Molecular-Weight
compliance
drug safety

self-administration
ambulatory Care
Pharmaceutical Services

Study placed in the following topic categories:

Body Weight
Embolism and Thrombosis
Embolism
Heparin, Low-Molecular-Weight
Vascular Diseases

Heparin
Thrombosis
Thromboembolism
Calcium heparin

Additional relevant MeSH terms:

Fibrin Modulating Agents
Anticoagulants
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Hematologic Agents

Fibrinolytic Agents
Cardiovascular Diseases
Cardiovascular Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009