OptiVol® Care Pathway
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|ClinicalTrials.gov Identifier: NCT00847288|
Recruitment Status : Completed
First Posted : February 19, 2009
Results First Posted : May 3, 2013
Last Update Posted : May 3, 2013
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure||Other: Monthly Review Arm Other: Quarterly Review Arm||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1682 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||OptiVol® Care Pathway|
|Study Start Date :||March 2009|
|Actual Primary Completion Date :||March 2011|
|Actual Study Completion Date :||May 2011|
Experimental: Monthly Review Arm
Patients enrolled at centers that are assigned to the monthly review arm will have their device data reviewed monthly
Other: Monthly Review Arm
Monthly review of Cardiac Compass Trends with OptiVol. This intervention is related to disease management.
Active Comparator: Quarterly Review Arm
Patients enrolled at centers that are assigned to the quarterly review arm will have their device data reviewed every 3 months
Other: Quarterly Review Arm
Quarterly review of Cardiac Compass Trends with OptiVol. This intervention is related to disease management.
- 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 [ Time Frame: 1 year ]
- Compare Changes in Subject Self-care Over Time in the Monthly Review Arm vs. Quarterly Review Arm [ Time Frame: 1 year ]
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.
- Identify Patient Groups Who Are More Likely to Have Clinical Actions Triggered by Monthly Rather Than Quarterly Reviews [ Time Frame: 1 year ]The 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.
- 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 [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00847288
Show 108 Study Locations
|Principal Investigator:||Wilson Tang, MD||Department of Cardiovascular Medicine, Cleveland Clinic|