Trial Outcomes & Findings for Weekly Monitoring Strategy of Capillary INR Versus Monthly Monitoring Strategy of Venous INR in Elderly Patients in a Nursing Home. (NCT NCT05561244)
NCT ID: NCT05561244
Last Updated: 2026-03-03
Results Overview
The CoaguChek INRange® device will be used. This small, portable monitoring medical device has already been used in several studies and can be used in hospital beds. After washing the patient's hands, the nurse will insert the strip test into the device, massaging the fingers and hand to activate blood circulation, and perform a capillary puncture using the lancet. An 8 μL drop of blood is required and must be deposited on the test strip less than 180 seconds after inserting the strip into the device and within 15 seconds after the start of blood drop formation. The International Normalized Ratio is displayed within one minute. When the nurse has the result, he/she will complete the VKA dose software (i.e. puncture number, strip number, current VKA type, current VKA dose, INRc value). The software will give the next puncture day and the correct VKA dose. If the INR \> 4, there will be an alert and the nurse will have to contact the general practitioner for the rest of the procedure.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
45 participants
Primary outcome timeframe
Over 6 months
Results posted on
2026-03-03
Participant Flow
patient recruted between 18/11/2022 and 27/11/2023, with a mean follow-up time of 153 ± 44 days in the controle arm and 160±62 days in the intervention arm
Unit of analysis: Nursing home
Participant milestones
| Measure |
CONTROL GROUP
Control group (n = 7 nursing homes, 19 patients). Patients are monitored as usual using the Venous International Normalised Ratio strategy. Practices did not changed (i.e. prospective observation of real-life practices; according to recommendations, at least 1 Venous International Normalised Ratio per month will usually be performed) and patients did not receive any supplementary intervention specific to the trial. A reminder of good International Normalised Ratio practices will be provided to nurses and prescribers. Each outcome is analyzed to the participant level.
|
INTERVENTIONAL GROUP
Intervention group (n = 9 nursing homes, 26 patients): Patients in the interventional group were monitored using the capillary International Normalised Ratio strategy every week, and more often if the International Normalised Ratio is not in the therapeutic target. Venous International Normalised Ratio punctures were also performed as described for the control group in order to calculate the Time in Therapeutic Range equivalently in both groups. Specific training in handling the device and the dose adjustment protocol were provided to nurses and prescribers. Each outcome is analyzed to the participant level.
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|---|---|---|
|
Overall Study
STARTED
|
19 7
|
26 9
|
|
Overall Study
COMPLETED
|
19 7
|
26 9
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
CONTROL GROUP
n=19 Participants
Control group (n = 7 nursing homes, 19 patients). Patients are monitored as usual using the Venous International Normalised Ratio strategy. Practices did not changed (i.e. prospective observation of real-life practices; according to recommendations, at least 1 Venous International Normalised Ratio per month will usually be performed) and patients did not receive any supplementary intervention specific to the trial. A reminder of good International Normalised Ratio practices will be provided to nurses and prescribers.
|
INTERVENTIONAL GROUP
n=26 Participants
Intervention group (n = 9 nursing homes, 26 patients): Patients in the interventional group were monitored using the capillary International Normalised Ratio strategy every week, and more often if the International Normalised Ratio is not in the therapeutic target. Venous International Normalised Ratio punctures were also performed as described for the control group in order to calculate the Time in Therapeutic Range equivalently in both groups. Specific training in handling the device and the dose adjustment protocol were provided to nurses and prescribers.
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
87 years
STANDARD_DEVIATION 10 • n=19 Participants
|
89 years
STANDARD_DEVIATION 6 • n=26 Participants
|
88 years
STANDARD_DEVIATION 8 • n=45 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=19 Participants
|
19 Participants
n=26 Participants
|
31 Participants
n=45 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=19 Participants
|
7 Participants
n=26 Participants
|
14 Participants
n=45 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
BMI
|
25.8 kg/m^2
STANDARD_DEVIATION 5.0 • n=19 Participants
|
25.8 kg/m^2
STANDARD_DEVIATION 7.0 • n=26 Participants
|
25.8 kg/m^2
STANDARD_DEVIATION 6.0 • n=45 Participants
|
PRIMARY outcome
Timeframe: Over 6 monthsThe CoaguChek INRange® device will be used. This small, portable monitoring medical device has already been used in several studies and can be used in hospital beds. After washing the patient's hands, the nurse will insert the strip test into the device, massaging the fingers and hand to activate blood circulation, and perform a capillary puncture using the lancet. An 8 μL drop of blood is required and must be deposited on the test strip less than 180 seconds after inserting the strip into the device and within 15 seconds after the start of blood drop formation. The International Normalized Ratio is displayed within one minute. When the nurse has the result, he/she will complete the VKA dose software (i.e. puncture number, strip number, current VKA type, current VKA dose, INRc value). The software will give the next puncture day and the correct VKA dose. If the INR \> 4, there will be an alert and the nurse will have to contact the general practitioner for the rest of the procedure.
Outcome measures
| Measure |
CONTROL GROUP
n=19 Participants
Control group (n = 7 nursing homes, 19 patients). Patients are monitored as usual using the Venous International Normalised Ratio strategy. Practices did not changed (i.e. prospective observation of real-life practices; according to recommendations, at least 1 Venous International Normalised Ratio per month will usually be performed) and patients did not receive any supplementary intervention specific to the trial. A reminder of good International Normalised Ratio practices will be provided to nurses and prescribers.
|
INTERVENTIONAL GROUP
n=26 Participants
Intervention group (n = 9 nursing homes, 26 patients): Patients in the interventional group were monitored using the capillary International Normalised Ratio strategy every week, and more often if the International Normalised Ratio is not in the therapeutic target. Venous International Normalised Ratio punctures were also performed as described for the control group in order to calculate the Time in Therapeutic Range equivalently in both groups. Specific training in handling the device and the dose adjustment protocol were provided to nurses and prescribers.
|
|---|---|---|
|
Time in Therapeutic Range Using the Capillary International Normalized Range Weekly Monitoring Strategy
|
43 percentage of time in therapeutic range
Standard Deviation 31
|
68 percentage of time in therapeutic range
Standard Deviation 21
|
SECONDARY outcome
Timeframe: Day 0 to Month 6Venous thromboembolic events (yes / no) occurring during the 6-month monitoring period will be recorded for each patient.
Outcome measures
| Measure |
CONTROL GROUP
n=19 Participants
Control group (n = 7 nursing homes, 19 patients). Patients are monitored as usual using the Venous International Normalised Ratio strategy. Practices did not changed (i.e. prospective observation of real-life practices; according to recommendations, at least 1 Venous International Normalised Ratio per month will usually be performed) and patients did not receive any supplementary intervention specific to the trial. A reminder of good International Normalised Ratio practices will be provided to nurses and prescribers.
|
INTERVENTIONAL GROUP
n=26 Participants
Intervention group (n = 9 nursing homes, 26 patients): Patients in the interventional group were monitored using the capillary International Normalised Ratio strategy every week, and more often if the International Normalised Ratio is not in the therapeutic target. Venous International Normalised Ratio punctures were also performed as described for the control group in order to calculate the Time in Therapeutic Range equivalently in both groups. Specific training in handling the device and the dose adjustment protocol were provided to nurses and prescribers.
|
|---|---|---|
|
Venous Thromboembolic Events Occurring During the 6-month Monitoring Period.
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Day 0 to Month 6Haemorrhagic events (yes / no) occurring during the 6-months monitoring period will be recorded for each patient.
Outcome measures
| Measure |
CONTROL GROUP
n=19 Participants
Control group (n = 7 nursing homes, 19 patients). Patients are monitored as usual using the Venous International Normalised Ratio strategy. Practices did not changed (i.e. prospective observation of real-life practices; according to recommendations, at least 1 Venous International Normalised Ratio per month will usually be performed) and patients did not receive any supplementary intervention specific to the trial. A reminder of good International Normalised Ratio practices will be provided to nurses and prescribers.
|
INTERVENTIONAL GROUP
n=26 Participants
Intervention group (n = 9 nursing homes, 26 patients): Patients in the interventional group were monitored using the capillary International Normalised Ratio strategy every week, and more often if the International Normalised Ratio is not in the therapeutic target. Venous International Normalised Ratio punctures were also performed as described for the control group in order to calculate the Time in Therapeutic Range equivalently in both groups. Specific training in handling the device and the dose adjustment protocol were provided to nurses and prescribers.
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|---|---|---|
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Haemorrhagic Events Occurring During the 6-month Monitoring Period.
|
2 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Day 0 to 6 monthsPercentage of Time in Therapeutic Range using International Normalized Range weekly monitoring strategy in patients ≤90.
Outcome measures
| Measure |
CONTROL GROUP
n=10 Participants
Control group (n = 7 nursing homes, 19 patients). Patients are monitored as usual using the Venous International Normalised Ratio strategy. Practices did not changed (i.e. prospective observation of real-life practices; according to recommendations, at least 1 Venous International Normalised Ratio per month will usually be performed) and patients did not receive any supplementary intervention specific to the trial. A reminder of good International Normalised Ratio practices will be provided to nurses and prescribers.
|
INTERVENTIONAL GROUP
n=16 Participants
Intervention group (n = 9 nursing homes, 26 patients): Patients in the interventional group were monitored using the capillary International Normalised Ratio strategy every week, and more often if the International Normalised Ratio is not in the therapeutic target. Venous International Normalised Ratio punctures were also performed as described for the control group in order to calculate the Time in Therapeutic Range equivalently in both groups. Specific training in handling the device and the dose adjustment protocol were provided to nurses and prescribers.
|
|---|---|---|
|
Time in Therapeutic Range Using International Normalized Range Weekly Monitoring Strategy in Patients ≤90.
|
43 percentage of time
Standard Deviation 28
|
72 percentage of time
Standard Deviation 23
|
SECONDARY outcome
Timeframe: Day 0 to 6 monthsTime in Therapeutic Range using the International Normalized Range weekly monitoring strategy in patients \>90.
Outcome measures
| Measure |
CONTROL GROUP
n=9 Participants
Control group (n = 7 nursing homes, 19 patients). Patients are monitored as usual using the Venous International Normalised Ratio strategy. Practices did not changed (i.e. prospective observation of real-life practices; according to recommendations, at least 1 Venous International Normalised Ratio per month will usually be performed) and patients did not receive any supplementary intervention specific to the trial. A reminder of good International Normalised Ratio practices will be provided to nurses and prescribers.
|
INTERVENTIONAL GROUP
n=10 Participants
Intervention group (n = 9 nursing homes, 26 patients): Patients in the interventional group were monitored using the capillary International Normalised Ratio strategy every week, and more often if the International Normalised Ratio is not in the therapeutic target. Venous International Normalised Ratio punctures were also performed as described for the control group in order to calculate the Time in Therapeutic Range equivalently in both groups. Specific training in handling the device and the dose adjustment protocol were provided to nurses and prescribers.
|
|---|---|---|
|
Time in Therapeutic Range Using the International Normalized Range Weekly Monitoring Strategy in Patients >90.
|
42 percentage of time
Standard Deviation 35
|
62 percentage of time
Standard Deviation 19
|
SECONDARY outcome
Timeframe: Day 0 to 6 monthsPopulation: No hospitalization during the time of the study. As such no analyse could be performed
Cost in terms of hospitalisations (due to haemorrhagic, ischemic and thromboembolic events) will be studied including the cost of the device (equipment and consumables) from the public health insurance's perspective and the nursing time from the point of view of the health care institution.
Outcome measures
| Measure |
CONTROL GROUP
Control group (n = 7 nursing homes, 19 patients). Patients are monitored as usual using the Venous International Normalised Ratio strategy. Practices did not changed (i.e. prospective observation of real-life practices; according to recommendations, at least 1 Venous International Normalised Ratio per month will usually be performed) and patients did not receive any supplementary intervention specific to the trial. A reminder of good International Normalised Ratio practices will be provided to nurses and prescribers.
|
INTERVENTIONAL GROUP
Intervention group (n = 9 nursing homes, 26 patients): Patients in the interventional group were monitored using the capillary International Normalised Ratio strategy every week, and more often if the International Normalised Ratio is not in the therapeutic target. Venous International Normalised Ratio punctures were also performed as described for the control group in order to calculate the Time in Therapeutic Range equivalently in both groups. Specific training in handling the device and the dose adjustment protocol were provided to nurses and prescribers.
|
|---|---|---|
|
Cost-consequences Study on the Weekly INRc Monitoring Strategy
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Over 6 monthsAssess, over the 6-month observation period, the agreement between INRc and INRv
Outcome measures
| Measure |
CONTROL GROUP
n=138 Blood Sample
Control group (n = 7 nursing homes, 19 patients). Patients are monitored as usual using the Venous International Normalised Ratio strategy. Practices did not changed (i.e. prospective observation of real-life practices; according to recommendations, at least 1 Venous International Normalised Ratio per month will usually be performed) and patients did not receive any supplementary intervention specific to the trial. A reminder of good International Normalised Ratio practices will be provided to nurses and prescribers.
|
INTERVENTIONAL GROUP
Intervention group (n = 9 nursing homes, 26 patients): Patients in the interventional group were monitored using the capillary International Normalised Ratio strategy every week, and more often if the International Normalised Ratio is not in the therapeutic target. Venous International Normalised Ratio punctures were also performed as described for the control group in order to calculate the Time in Therapeutic Range equivalently in both groups. Specific training in handling the device and the dose adjustment protocol were provided to nurses and prescribers.
|
|---|---|---|
|
Agreement Between Capillary and Veinous Measures
|
0.89 Intra-Class Correlation Coeficient (ICC)
Interval 0.84 to 0.92
|
—
|
Adverse Events
CONTROL GROUP
Serious events: 0 serious events
Other events: 8 other events
Deaths: 8 deaths
INTERVENTIONAL GROUP
Serious events: 0 serious events
Other events: 18 other events
Deaths: 2 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
CONTROL GROUP
n=19 participants at risk
Control group (n = 7 nursing homes, 19 patients). Patients are monitored as usual using the Venous International Normalised Ratio strategy. Practices did not changed (i.e. prospective observation of real-life practices; according to recommendations, at least 1 Venous International Normalised Ratio per month will usually be performed) and patients did not receive any supplementary intervention specific to the trial. A reminder of good International Normalised Ratio practices will be provided to nurses and prescribers. Each outcome is analyzed to the participant level.
|
INTERVENTIONAL GROUP
n=26 participants at risk
Intervention group (n = 9 nursing homes, 26 patients): Patients in the interventional group were monitored using the capillary International Normalised Ratio strategy every week, and more often if the International Normalised Ratio is not in the therapeutic target. Venous International Normalised Ratio punctures were also performed as described for the control group in order to calculate the Time in Therapeutic Range equivalently in both groups. Specific training in handling the device and the dose adjustment protocol were provided to nurses and prescribers. Each outcome is analyzed to the participant level.
|
|---|---|---|
|
Blood and lymphatic system disorders
Bleeding
|
10.5%
2/19 • Number of events 3 • From Day 0 to 6 months follow-up
|
26.9%
7/26 • Number of events 7 • From Day 0 to 6 months follow-up
|
|
Musculoskeletal and connective tissue disorders
Fall
|
31.6%
6/19 • Number of events 11 • From Day 0 to 6 months follow-up
|
53.8%
14/26 • Number of events 28 • From Day 0 to 6 months follow-up
|
|
Nervous system disorders
Confusion
|
15.8%
3/19 • Number of events 3 • From Day 0 to 6 months follow-up
|
15.4%
4/26 • Number of events 5 • From Day 0 to 6 months follow-up
|
|
General disorders
Fever
|
15.8%
3/19 • Number of events 3 • From Day 0 to 6 months follow-up
|
19.2%
5/26 • Number of events 7 • From Day 0 to 6 months follow-up
|
|
Renal and urinary disorders
Renal failure
|
10.5%
2/19 • Number of events 2 • From Day 0 to 6 months follow-up
|
7.7%
2/26 • Number of events 3 • From Day 0 to 6 months follow-up
|
|
Gastrointestinal disorders
Transit issues
|
5.3%
1/19 • Number of events 1 • From Day 0 to 6 months follow-up
|
23.1%
6/26 • Number of events 6 • From Day 0 to 6 months follow-up
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place