ThromboembolismPhase 4NCT00794560
Self-management of Low Molecular Weight Heparin Therapy
A Phase 4 study testing patient education in people with Thromboembolism, run by University Hospital, Basel, Switzerland at 2 sites in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thromboembolism
- What is being tested?
- patient education
- Type of treatment
- Pill or oral medicine, Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 2 sitesSwitzerland
- Study dates
- Jun 2007to Aug 2009
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.)
Who cannot join
- patient's home far away from study center
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
University Hospital of Basle, Switzerland
Basel, CH-4031
Kantonsspital Baselland, Switzerland
Bruderholz, CH-4101
About this study
Official title: Self-management of Heparin Therapy - Drug Use Problems and Compliance With Self-injected Low Molecular Weight Heparin in Ambulatory Care
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.
Read the 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)
- Conditions
- Thromboembolism
- Being tested
- patient education
- Keywords
- Heparin, Low-Molecular-Weight, compliance, drug safety, self-administration, ambulatory Care, Pharmaceutical Services
- Medical subject headings
- Thromboembolism, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
patient educationBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: 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 Receives: Behavioral: patient education |
| daily life setting: standard care | No intervention | Recruitment of patients in community pharmacies into control group (standard care in community pharmacy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: during the individual drug therapy, an average of 18 days
Secondary outcomes (2)
Compliance
objectively determined by syringe count Therapy durations varied individually depending on the indication of the drug therapy (days to weeks).
Measured: at the end of the individual drug therapy, an average of 18 days
Patient Satisfaction
Measured: at the end of the individual drug therapy, an average of 18 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2008 (estimated)
- Study startJun 2007
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ThromboembolismStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Kurt E. Hersberger, Prof. PhD, Principal investigator, Pharmaceutical Care Research Group, University of Basle, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00794560
- Sponsor's protocol ID
- NRA 630 00 23
- Other IDs
- EKBB 95/07
- Status last verified
- Nov 2014
- First submitted
- 18 Nov 2008
- Last updated
- 18 Nov 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-management of Heparin Therapy - Drug Use Problems and Compliance With Self-injected Low Molecular Weight Heparin in Ambulatory Care
- ClinicalTrials.gov ID
- NCT00794560
- Acronym / sponsor ID
- NRA 630 00 23
- Conditions
- Thromboembolism
- Keywords
- Heparin, Low-Molecular-Weight, compliance, drug safety, self-administration, ambulatory Care, Pharmaceutical Services
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Jun 2007
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 20 Nov 2008 (estimated)
- Results
- Posted 13 Aug 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| clinical setting: intervention | Experimental | Behavioral: patient educationRecruitment 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 | Behavioral: patient educationRecruitment 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
- Dalteparin
- all LMWH (ready-to-use syringes)
Key exclusion criteria (1 listed)
- patient's home far away from study center
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| patient educationPossible, 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 | Behavioural | clinical setting: intervention, daily life setting: intervention |
Primary outcome
Drug Use Problems
Time frame: during the individual drug therapy, an average of 18 days
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.
2 secondary outcomes
Compliance
Time frame: at the end of the individual drug therapy, an average of 18 days
Patient Satisfaction
Time frame: at the end of the individual drug therapy, an average of 18 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publicationMengiardi 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kurt E. Hersberger, Prof. PhD principal investigator
Pharmaceutical Care Research Group, University of Basle, Switzerland
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing patient education in people with Thromboembolism, run by University Hospital, Basel, Switzerland at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drug Use Problems (time frame: during the individual drug therapy, an average of 18 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00794560, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2014.