Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| EKBB 95/07 | Other Identifier | ethics committee |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| clinical setting: intervention | Experimental | 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 |
|
| 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. Intervention: patient education |
|
| daily life setting: standard care | No Intervention | Recruitment of patients in community pharmacies into control group (standard care in community pharmacy) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| patient education | Behavioral | Possible, individualized interventions:
|
| Measure | Description | Time Frame |
|---|---|---|
| Drug Use Problems | 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. | during the individual drug therapy, an average of 18 days |
| Measure | Description | Time Frame |
|---|---|---|
| Compliance | objectively determined by syringe count Therapy durations varied individually depending on the indication of the drug therapy (days to weeks). | at the end of the individual drug therapy, an average of 18 days |
| Patient Satisfaction |
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kurt E. Hersberger, Prof. PhD | Pharmaceutical Care Research Group, University of Basle, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Basle, Switzerland | Basel | CH-4031 | Switzerland | |||
| Kantonsspital Baselland, Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | 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 |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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:
|
| FG001 | Clinical Setting: Standard Care | Recruitment of patients in the hospital into the randomized control group (standard care in community pharmacy) |
| FG002 | 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:
|
| FG003 | Daily Life Setting: Standard Care | Recruitment of patients in community pharmacies into control group (standard care in community pharmacy) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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:
|
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Drug Use Problems | 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. | Posted | Mean | Standard Deviation | scores on a scale | during the individual drug therapy, an average of 18 days |
|
During the entire individual s.c. injection therapy, up to 6 weeks.
Therapy durations varied individually depending on the indication of the drug therapy (days to weeks).
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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:
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Allergy / hypersensitivity | Skin and subcutaneous tissue disorders | hospitalisation due to allergy, completely recovered |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hematoma at injection site | Skin and subcutaneous tissue disorders |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Seraina Mengiardi | Pharmaceutical Care Research Group, University of Basle, Switzerland | 061 267 15 29 | 0041 | seraina.mengiardi@unibas.ch |
Not provided
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D010349 | Patient Compliance |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010342 | Patient Acceptance of Health Care |
Not provided
Not provided
| ID | Term |
|---|---|
| D010353 | Patient Education as Topic |
| ID | Term |
|---|---|
| D006266 | Health Education |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| at the end of the individual drug therapy, an average of 18 days |
| Bruderholz |
| CH-4101 |
| Switzerland |
| BG001 | Clinical Setting: Standard Care | Recruitment of patients in the hospital into the randomized control group (standard care in community pharmacy) |
| BG002 | 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:
|
| BG003 | Daily Life Setting: Standard Care | Recruitment of patients in community pharmacies into control group (standard care in community pharmacy) |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Clinical Setting: Standard Care | Recruitment of patients in the hospital into the randomized control group (standard care in community pharmacy) |
| OG002 | 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:
|
| OG003 | Daily Life Setting: Standard Care | Recruitment of patients in community pharmacies into control group (standard care in community pharmacy) |
|
|
| Secondary | Compliance | objectively determined by syringe count Therapy durations varied individually depending on the indication of the drug therapy (days to weeks). | Posted | Mean | Standard Deviation | percentage of syringes | at the end of the individual drug therapy, an average of 18 days |
|
|
|
| Secondary | Patient Satisfaction | Not Posted | at the end of the individual drug therapy, an average of 18 days |
| 0 |
| 36 |
| 33 |
| 36 |
| EG001 | Clinical Setting: Standard Care | Recruitment of patients in the hospital into the randomized control group (standard care in community pharmacy) | 1 | 36 | 29 | 36 |
| EG002 | 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:
| 0 | 44 | 37 | 44 |
| EG003 | Daily Life Setting: Standard Care | Recruitment of patients in community pharmacies into control group (standard care in community pharmacy) | 0 | 38 | 17 | 38 |
|
| mild injection site irritation/burning | Skin and subcutaneous tissue disorders |
|
| hematoma in general | Skin and subcutaneous tissue disorders |
|
| site pain | Skin and subcutaneous tissue disorders |
|
| induration | Skin and subcutaneous tissue disorders |
|
| exanthema | Skin and subcutaneous tissue disorders |
|
Not provided
Not provided
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |