Clinical trial NCT00794560: Self-management of Low Molecular Weight Heparin Therapy
Official title: Self-management of Heparin Therapy - Drug Use Problems and Compliance With Self-injected Low Molecular Weight Heparin in Ambulatory Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Thromboembolism
Keywords: Heparin, Low-Molecular-Weight
compliance
drug safety
self-administration
ambulatory Care
Pharmaceutical Services
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2008-11-20
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_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)

Eligibility 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

Primary outcomes:
measure: Drug Use Problems
timeFrame: during the individual drug therapy, an average of 18 days
Secondary outcomes:
measure: Compliance
timeFrame: at the end of the individual drug therapy, an average of 18 days
measure: Patient Satisfaction
timeFrame: at the end of the individual drug therapy, an average of 18 days
Other outcomes:
Locations:
city: Basle
country: Switzerland
facility: University Hospital of Basle, Switzerland
city: Bruderholz
country: Switzerland
facility: Kantonsspital Baselland, Switzerland
Study officials:
affiliation: Pharmaceutical Care Research Group, University of Basle, Switzerland
name: Kurt E. Hersberger, Prof. PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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