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Sponsors and Collaborators: |
University Hospital, Basel, Switzerland Pfizer by an "Investigator Initiated Research Grant" |
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Information provided by: | University Hospital, Basel, Switzerland |
ClinicalTrials.gov Identifier: | NCT00794560 |
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 |
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Thromboembolism |
Behavioral: patient education |
Phase IV |
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 |
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 |
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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.
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Behavioral: patient education
Possible, individualized interventions:
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clinical setting: standard care: No Intervention
Recruitment of patients in the hospital into the randomized control group (standard care in community pharmacy)
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daily life setting: intervention: Experimental
Recruitment of patients in trained community pharmacies into the intervention group. Intervention is done by trained pharmacists.
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Behavioral: patient education
Possible, individualized interventions:
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daily life setting: standard care: No Intervention
Recruitment of patients in community pharmacies into control group (standard care in community pharmacy)
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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:
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
german / english speaking
-> clinical setting:
Dalteparin
-> daily life setting:
Exclusion Criteria:
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 |
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 |
Principal Investigator: | Kurt E. Hersberger, PhD | Institute of Clinical Pharmacy, University of Basle, Switzerland |
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 |
Heparin, Low-Molecular-Weight compliance drug safety |
self-administration ambulatory Care Pharmaceutical Services |
Body Weight Embolism and Thrombosis Embolism Heparin, Low-Molecular-Weight Vascular Diseases |
Heparin Thrombosis Thromboembolism Calcium heparin |
Fibrin Modulating Agents Anticoagulants Molecular Mechanisms of Pharmacological Action Therapeutic Uses Hematologic Agents |
Fibrinolytic Agents Cardiovascular Diseases Cardiovascular Agents Pharmacologic Actions |