IMPROVE HF: Registry to Improve the Use of Evidence-Based Heart Failure Therapies in the Outpatient Setting (IMPROVE-HF)

This study has been completed.
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier:
NCT00303979
First received: March 15, 2006
Last updated: November 21, 2012
Last verified: November 2012
Results First Received: November 21, 2012  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Conditions: Heart Failure, Congestive
Myocardial Infarction
Ventricular Dysfunction, Left

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Cohort A (Longitudinal)

Longitudinal Cohort: Approximately 15,000 patients followed at baseline, 12 months and 24 months

Evidence based guidelines and tools : Education, guidelines, tools

Cohort B (6 Month)

6 Month Cohort: Approximately 10,000 patients reviewed at single time point

Evidence based guidelines and tools : Education, guidelines, tools

Cohort C (18 Month)

18 Month Cohort: Approximately 10,000 patients reviewed at single time point

Evidence based guidelines and tools : Education, guidelines, tools


Participant Flow for 3 periods

Period 1:   Longitudinal (Baseline, 12 and 24 Month)
    Cohort A (Longitudinal)     Cohort B (6 Month)     Cohort C (18 Month)  
STARTED     15177 [1]   0     0  
COMPLETED     7605 [2]   0     0  
NOT COMPLETED     7572     0     0  
[1] at Baseline
[2] at 24 Month

Period 2:   Single Time Point (6 Month)
    Cohort A (Longitudinal)     Cohort B (6 Month)     Cohort C (18 Month)  
STARTED     0     9992     0  
COMPLETED     0     9992     0  
NOT COMPLETED     0     0     0  

Period 3:   Single Time Point (18 Month)
    Cohort A (Longitudinal)     Cohort B (6 Month)     Cohort C (18 Month)  
STARTED     0     0     9641  
COMPLETED     0     0     9641  
NOT COMPLETED     0     0     0  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Cohort A (Longitudinal)

Longitudinal Cohort: Approximately 15,000 patients followed at baseline, 12 months and 24 months

Evidence based guidelines and tools : Education, guidelines, tools

Cohort B (6 Month)

6 Month Cohort: Approximately 10,000 patients reviewed at single time point

Evidence based guidelines and tools : Education, guidelines, tools

Cohort C (18 Month)

18 Month Cohort: Approximately 10,000 patients reviewed at single time point

Evidence based guidelines and tools : Education, guidelines, tools

Total Total of all reporting groups

Baseline Measures
    Cohort A (Longitudinal)     Cohort B (6 Month)     Cohort C (18 Month)     Total  
Number of Participants  
[units: participants]
  15177     9992     9641     34810  
Age  
[units: years]
Mean ± Standard Deviation
  68.7  ± 13.2     68.3  ± 13.2     68.2  ± 13.6     68.4  ± 13.3  
Age, Customized  
[units: participants]
       
<=64 years     5274     3606     3539     12419  
Between 64 and 76 years     5127     3344     3089     11560  
>76 years     4748     3041     3010     10799  
Missing     28     1     3     32  
Gender, Customized  
[units: participants]
       
Female     4383     2918     2827     10128  
Male     10787     7069     6814     24670  
Missing     7     5     0     12  
Region of Enrollment  
[units: participants]
       
United States     15177     9992     9641     34810  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   To Observe Over the Aggregate IMPROVE-HF Practice Sites a Relative 20% or Greater Improvement in at Least 2 of the 7 Performance Measures at 24 Months Compared With Baseline.   [ Time Frame: 24 Month ]

2.  Secondary:   Evaluate the Proportion of Sites That Demonstrate a Relative 20% or Greater Improvement in 2 or More of the 7 Performance Measures at 24 Months as Compared to Baseline.   [ Time Frame: Study Completion ]

3.  Secondary:   Observe the Relative Improvement From Baseline to 24M in Composite Score for the Aggregate Practices.   [ Time Frame: 24 months ]

4.  Secondary:   Observe the Relative Improvement From Baseline to 6M in Composite Score for the Aggregate Practices.   [ Time Frame: 6 Month ]

5.  Secondary:   Observe the Relative Improvement From Baseline to 18M in Composite Score for the Aggregate Practices.   [ Time Frame: 18 Month ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: IMPROVE HF, Clinical Research Specialist
Organization: Medtronic Cardiac Rhythm Disease Management
e-mail: medtronicCRMtrials@medtronic.com


No publications provided by Medtronic Cardiac Rhythm Disease Management

Publications automatically indexed to this study:


Responsible Party: Medtronic Cardiac Rhythm Disease Management
ClinicalTrials.gov Identifier: NCT00303979     History of Changes
Other Study ID Numbers: 258
Study First Received: March 15, 2006
Results First Received: November 21, 2012
Last Updated: November 21, 2012
Health Authority: United States: Institutional Review Board