Trial Outcomes & Findings for Self-management of Low Molecular Weight Heparin Therapy (NCT NCT00794560)
NCT ID: NCT00794560
Last Updated: 2014-11-18
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
154 participants
Primary outcome timeframe
during the individual drug therapy, an average of 18 days
Results posted on
2014-11-18
Participant Flow
Participant milestones
| Measure |
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:
* 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
Recruitment of patients in the hospital into the randomized control group (standard care in community pharmacy)
|
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:
* 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
Recruitment of patients in community pharmacies into control group (standard care in community pharmacy)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
36
|
36
|
44
|
38
|
|
Overall Study
COMPLETED
|
33
|
32
|
40
|
34
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
4
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Self-management of Low Molecular Weight Heparin Therapy
Baseline characteristics by cohort
| Measure |
Clinical Setting: Intervention
n=33 Participants
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:
* 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
n=32 Participants
Recruitment of patients in the hospital into the randomized control group (standard care in community pharmacy)
|
Daily Life Setting: Intervention
n=40 Participants
Recruitment of patients in trained community pharmacies into the intervention group. Intervention is done by trained pharmacists.
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
n=34 Participants
Recruitment of patients in community pharmacies into control group (standard care in community pharmacy)
|
Total
n=139 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
56 years
n=93 Participants
|
56 years
n=4 Participants
|
51 years
n=27 Participants
|
54 years
n=483 Participants
|
54 years
n=36 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
18 Participants
n=483 Participants
|
70 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
23 Participants
n=27 Participants
|
16 Participants
n=483 Participants
|
69 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: during the individual drug therapy, an average of 18 daysDuring 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.
Outcome measures
| Measure |
Clinical Setting: Intervention
n=33 Participants
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:
* 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
n=32 Participants
Recruitment of patients in the hospital into the randomized control group (standard care in community pharmacy)
|
Daily Life Setting: Intervention
n=40 Participants
Recruitment of patients in trained community pharmacies into the intervention group. Intervention is done by trained pharmacists.
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
n=34 Participants
Recruitment of patients in community pharmacies into control group (standard care in community pharmacy)
|
|---|---|---|---|---|
|
Drug Use Problems
|
1.25 scores on a scale
Standard Deviation 0.27
|
0.86 scores on a scale
Standard Deviation 0.33
|
1.20 scores on a scale
Standard Deviation 0.41
|
1.17 scores on a scale
Standard Deviation 0.40
|
SECONDARY outcome
Timeframe: at the end of the individual drug therapy, an average of 18 daysobjectively determined by syringe count Therapy durations varied individually depending on the indication of the drug therapy (days to weeks).
Outcome measures
| Measure |
Clinical Setting: Intervention
n=33 Participants
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:
* 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
n=32 Participants
Recruitment of patients in the hospital into the randomized control group (standard care in community pharmacy)
|
Daily Life Setting: Intervention
n=40 Participants
Recruitment of patients in trained community pharmacies into the intervention group. Intervention is done by trained pharmacists.
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
n=34 Participants
Recruitment of patients in community pharmacies into control group (standard care in community pharmacy)
|
|---|---|---|---|---|
|
Compliance
|
94.5 percentage of syringes
Standard Deviation 10.5
|
96.2 percentage of syringes
Standard Deviation 10.6
|
95.1 percentage of syringes
Standard Deviation 10.0
|
97.5 percentage of syringes
Standard Deviation 4.2
|
SECONDARY outcome
Timeframe: at the end of the individual drug therapy, an average of 18 daysOutcome measures
Outcome data not reported
Adverse Events
Clinical Setting: Intervention
Serious events: 0 serious events
Other events: 33 other events
Deaths: 0 deaths
Clinical Setting: Standard Care
Serious events: 1 serious events
Other events: 29 other events
Deaths: 0 deaths
Daily Life Setting: Intervention
Serious events: 0 serious events
Other events: 37 other events
Deaths: 0 deaths
Daily Life Setting: Standard Care
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Clinical Setting: Intervention
n=36 participants at risk
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:
* 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
n=36 participants at risk
Recruitment of patients in the hospital into the randomized control group (standard care in community pharmacy)
|
Daily Life Setting: Intervention
n=44 participants at risk
Recruitment of patients in trained community pharmacies into the intervention group. Intervention is done by trained pharmacists.
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
n=38 participants at risk
Recruitment of patients in community pharmacies into control group (standard care in community pharmacy)
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Allergy / hypersensitivity
|
0.00%
0/36 • 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).
|
2.8%
1/36 • Number of events 1 • 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).
|
0.00%
0/44 • 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).
|
0.00%
0/38 • 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).
|
Other adverse events
| Measure |
Clinical Setting: Intervention
n=36 participants at risk
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:
* 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
n=36 participants at risk
Recruitment of patients in the hospital into the randomized control group (standard care in community pharmacy)
|
Daily Life Setting: Intervention
n=44 participants at risk
Recruitment of patients in trained community pharmacies into the intervention group. Intervention is done by trained pharmacists.
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
n=38 participants at risk
Recruitment of patients in community pharmacies into control group (standard care in community pharmacy)
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
hematoma at injection site
|
86.1%
31/36 • Number of events 31 • 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).
|
72.2%
26/36 • Number of events 26 • 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).
|
79.5%
35/44 • Number of events 35 • 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).
|
39.5%
15/38 • Number of events 15 • 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).
|
|
Skin and subcutaneous tissue disorders
mild injection site irritation/burning
|
44.4%
16/36 • Number of events 16 • 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).
|
47.2%
17/36 • Number of events 17 • 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).
|
50.0%
22/44 • Number of events 22 • 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).
|
13.2%
5/38 • Number of events 5 • 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).
|
|
Skin and subcutaneous tissue disorders
hematoma in general
|
5.6%
2/36 • Number of events 2 • 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).
|
5.6%
2/36 • Number of events 2 • 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).
|
11.4%
5/44 • Number of events 5 • 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).
|
7.9%
3/38 • Number of events 3 • 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).
|
|
Skin and subcutaneous tissue disorders
site pain
|
8.3%
3/36 • Number of events 3 • 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).
|
0.00%
0/36 • 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).
|
9.1%
4/44 • Number of events 4 • 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).
|
7.9%
3/38 • Number of events 3 • 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).
|
|
Skin and subcutaneous tissue disorders
induration
|
13.9%
5/36 • Number of events 5 • 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).
|
0.00%
0/36 • 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).
|
6.8%
3/44 • Number of events 3 • 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).
|
0.00%
0/38 • 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).
|
|
Skin and subcutaneous tissue disorders
exanthema
|
2.8%
1/36 • Number of events 1 • 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).
|
5.6%
2/36 • Number of events 2 • 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).
|
0.00%
0/44 • 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).
|
0.00%
0/38 • 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).
|
Additional Information
Dr. Seraina Mengiardi
Pharmaceutical Care Research Group, University of Basle, Switzerland
Phone: 061 267 15 29
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place