Trial Outcomes & Findings for OptiVol® Care Pathway (NCT NCT00847288)
NCT ID: NCT00847288
Last Updated: 2013-05-03
Results Overview
COMPLETED
PHASE4
1682 participants
1 year
2013-05-03
Participant Flow
The recruitment period of OptiVol Care Pathway Study was from April 2, 2009 to March 7, 2011.
There were 1682 enrollments from 106 study centers. 1668 of those enrollments met the inclusion criteria for the study and thus were randomized. Fourteen did not meet the inclusion criteria and were excluded before randomization.
Participant milestones
| Measure |
Monthly Review Arm
Patients enrolled at centers that are assigned to the monthly review arm will have their device data reviewed monthly
|
Quarterly Review Arm
Patients enrolled at centers that are assigned to the quarterly review arm will have their device data reviewed every 3 months
|
|---|---|---|
|
Overall Study
STARTED
|
841
|
827
|
|
Overall Study
COMPLETED
|
811
|
780
|
|
Overall Study
NOT COMPLETED
|
30
|
47
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
OptiVol® Care Pathway
Baseline characteristics by cohort
| Measure |
Monthly Review Arm
n=841 Participants
Patients enrolled at centers that are assigned to the monthly review arm will have their device data reviewed monthly
|
Quarterly Review Arm
n=827 Participants
Patients enrolled at centers that are assigned to the quarterly review arm will have their device data reviewed every 3 months
|
Total
n=1668 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
68.3 years
STANDARD_DEVIATION 11.8 • n=99 Participants
|
67.6 years
STANDARD_DEVIATION 11.6 • n=107 Participants
|
68.0 years
STANDARD_DEVIATION 11.7 • n=206 Participants
|
|
Sex: Female, Male
Female
|
238 Participants
n=99 Participants
|
224 Participants
n=107 Participants
|
462 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
603 Participants
n=99 Participants
|
603 Participants
n=107 Participants
|
1206 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
749 participants
n=99 Participants
|
621 participants
n=107 Participants
|
1370 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
53 participants
n=99 Participants
|
98 participants
n=107 Participants
|
151 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
American Indian
|
5 participants
n=99 Participants
|
2 participants
n=107 Participants
|
7 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 participants
n=99 Participants
|
8 participants
n=107 Participants
|
12 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hawaiian
|
2 participants
n=99 Participants
|
2 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
20 participants
n=99 Participants
|
69 participants
n=107 Participants
|
89 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Multiple
|
0 participants
n=99 Participants
|
3 participants
n=107 Participants
|
3 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 participants
n=99 Participants
|
4 participants
n=107 Participants
|
7 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Not Available
|
5 participants
n=99 Participants
|
20 participants
n=107 Participants
|
25 participants
n=206 Participants
|
|
Height
|
68.2 inches
STANDARD_DEVIATION 4.0 • n=99 Participants
|
68.1 inches
STANDARD_DEVIATION 4.2 • n=107 Participants
|
68.1 inches
STANDARD_DEVIATION 4.1 • n=206 Participants
|
|
Weight
|
196.5 lbs
STANDARD_DEVIATION 45.9 • n=99 Participants
|
196.1 lbs
STANDARD_DEVIATION 48.8 • n=107 Participants
|
196.3 lbs
STANDARD_DEVIATION 47.4 • n=206 Participants
|
|
Systolic blood pressure
|
118.6 mmHg
STANDARD_DEVIATION 17.0 • n=99 Participants
|
122.7 mmHg
STANDARD_DEVIATION 17.1 • n=107 Participants
|
120.6 mmHg
STANDARD_DEVIATION 17.2 • n=206 Participants
|
|
Diastolic blood pressure
|
69.2 mmHg
STANDARD_DEVIATION 10.1 • n=99 Participants
|
72.4 mmHg
STANDARD_DEVIATION 10.7 • n=107 Participants
|
70.8 mmHg
STANDARD_DEVIATION 10.5 • n=206 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: All patients enrolled in the study, who have eligible study device, signed inform consent, signed HIPAA, and have at least one OptiVol threshold crossing post the start date, were included in this analysis.
Outcome measures
| Measure |
Monthly Review Arm
n=639 Participants
Patients enrolled at centers that are assigned to the monthly review arm will have their device data reviewed monthly
|
Quarterly Review Arm
n=605 Participants
Patients enrolled at centers that are assigned to the quarterly review arm will have their device data reviewed every 3 months
|
|---|---|---|
|
Compare the Time to Initiation of Clinical Action Prompted by an OptiVol Threshold Crossing Between Monthly and Quarterly Review of Cardiac Compass Trends With OptiVol
|
8.9 months
Interval 7.2 to 9.9
|
12.4 months
Interval 12.0 to 13.1
|
SECONDARY outcome
Timeframe: 1 yearPopulation: For each component, the subject needs to have baseline and 6 (or 12) month measurements to calculate the changes. Subjects included for the each component are as following: Maintenance (or Confidence): 720 and 675 for monthly and quarterly arms at 6 mo, respectively, 640 and 588 at 12 mo. Management, 166 and 141 at 6 mo, 166 and 104 at 12 mo.
There are 3 summary scale scores for the Self-Care of Heart Failure Index (SCHFI) form: self-care maintenance score (Section A), management score (Section B), and confidence score (Section C). Each scale score is standardized to a 0 to 100 range, with 0 indicating the worst and 100 indicating the best performance for each scale score. Here, changes in each scale score between 6 month follow-up and baseline and between 12 month follow-up and baseline are the secondary outcome measures. Specifically, change at 6 (or 12) month follow-up is calculated as a scale score at 6 (or 12) month follow-up subtracts that at baseline. These changes range from -100 to 100 with 0 indicating no change at all, -100 indicating maximum decrease and 100 indicating maximum increase that is possible from baseline for a self-care scale score.
Outcome measures
| Measure |
Monthly Review Arm
n=720 Participants
Patients enrolled at centers that are assigned to the monthly review arm will have their device data reviewed monthly
|
Quarterly Review Arm
n=640 Participants
Patients enrolled at centers that are assigned to the quarterly review arm will have their device data reviewed every 3 months
|
|---|---|---|
|
Compare Changes in Subject Self-care Over Time in the Monthly Review Arm vs. Quarterly Review Arm
Maintenance (6 mo)
|
1.94 units on a scale
Standard Deviation 13.31
|
-0.77 units on a scale
Standard Deviation 13.65
|
|
Compare Changes in Subject Self-care Over Time in the Monthly Review Arm vs. Quarterly Review Arm
Management (6 mo)
|
-1.72 units on a scale
Standard Deviation 24.33
|
-1.05 units on a scale
Standard Deviation 22.99
|
|
Compare Changes in Subject Self-care Over Time in the Monthly Review Arm vs. Quarterly Review Arm
Confidence (6 mo)
|
-1.19 units on a scale
Standard Deviation 20.71
|
-2.46 units on a scale
Standard Deviation 20.96
|
|
Compare Changes in Subject Self-care Over Time in the Monthly Review Arm vs. Quarterly Review Arm
Maintenance (12 mo)
|
1.1 units on a scale
Standard Deviation 13.16
|
-1.42 units on a scale
Standard Deviation 14.73
|
|
Compare Changes in Subject Self-care Over Time in the Monthly Review Arm vs. Quarterly Review Arm
Management (12 mo)
|
-2.32 units on a scale
Standard Deviation 24.96
|
-4.17 units on a scale
Standard Deviation 25.27
|
|
Compare Changes in Subject Self-care Over Time in the Monthly Review Arm vs. Quarterly Review Arm
Confidence (12 mo)
|
0.32 units on a scale
Standard Deviation 21.64
|
-1.74 units on a scale
Standard Deviation 22.65
|
SECONDARY outcome
Timeframe: 1 yearThe binary outcome of having clinical actions taken (Yes/No) is recorded within one month interval for the monthly review group, and within three months interval for the quarterly review group. To make the endpoints of both groups comparable, data from monthly review group are converted as they were collected quarterly. For example, the month 1, 2 and 3 visits of monthly review group are combined as one visit. If there is at least one action taken in any of these three monthly visits, the action taken variable for the combined visit will be recorded as 'yes'. Unscheduled visits in both groups are lumped to the next quarterly time point.
Outcome measures
| Measure |
Monthly Review Arm
n=3065 visits
Patients enrolled at centers that are assigned to the monthly review arm will have their device data reviewed monthly
|
Quarterly Review Arm
n=2732 visits
Patients enrolled at centers that are assigned to the quarterly review arm will have their device data reviewed every 3 months
|
|---|---|---|
|
Identify Patient Groups Who Are More Likely to Have Clinical Actions Triggered by Monthly Rather Than Quarterly Reviews
|
0.26 percentage of visits with action
Interval 0.24 to 0.28
|
0.19 percentage of visits with action
Interval 0.17 to 0.2
|
SECONDARY outcome
Timeframe: 1 yearOutcome measures
| Measure |
Monthly Review Arm
n=813 Participants
Patients enrolled at centers that are assigned to the monthly review arm will have their device data reviewed monthly
|
Quarterly Review Arm
n=780 Participants
Patients enrolled at centers that are assigned to the quarterly review arm will have their device data reviewed every 3 months
|
|---|---|---|
|
Compare the Time to Initiation of Clinical Action With or Without an OptiVol Threshold Crossing Between Monthly and Quarterly Review of Cardiac Compass Trends With OptiVol
|
9.0 months
Interval 7.2 to 10.8
|
13.2 months
Interval 12.6 to 16.3
|
Adverse Events
Monthly Review Arm
Quarterly Review Arm
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
OptiVol Care Pathway Clinical Team
Medtronic Cardiac Rhythm Disease Management
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER