CareLink® Network Evaluation
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Medtronic CareLink® Network Evaluation Protocol|
- Comparison of Remote Device Check and In-clinic Device Assessment [ Time Frame: Baseline to max. 12 months ]"Investigators were asked the following question: how did the Medtronic CareLink system matched their personal expectation/goals and had to answer with multiple answer using the following ranking Significantly exceeded, Goals met, No expectations, Not met, Not met at all: Question 1) Newest technology for my patients. Q2) Increased patient safety. Q3) Increased patient satisfaction. Q4) Improved quality of life for my patients. Q5) Improved follow up after therapy/shock delivery of for symptomatic patients, adverse events. Q6) Increased hospital efficiency. Q7) Increased follow up quality. Q8) More flexible follow up schemes possible. Q9) Better management of the increased number of follow ups. Q10) Increased satisfaction of hospital personnel. Q11) Other goals"
- Patient Ease of Use of, and Satisfaction With the Medtronic CareLink® Monitor (Including Percentage of Patients Who Prefer Follow up With Medtronic CareLink® Compared to Traditional In-clinic Device Follow-up) [ Time Frame: Baseline to max. 12 months ]"Participants were asked questions to which they could have respond multiple answers. 1) Which form of device follow up do you prefer? Answers: Monitor from home and in hospital follow up is necessary; Follow up only in hospital; No preference, and 2) How would you judge the user friendliness of the monitor in total? Answers: Very easy; Easy; Difficult; Missing Data, and 3) How did the monitor changed your daily life? did you felt more or less safe? Answers: Much more safe; Safe; No influence; Unsafe; Missing data
- Clinician Ease of Use of, and Satisfaction With, the Medtronic CareLink® Monitor and Website (Including Clinician General Preference, if Any, for Medtronic CareLink® Compared to Traditional In-clinic Device Follow-up) [ Time Frame: Baseline to max. 12 months ]
- Clinic-specific Clinical Value of Medtronic CareLink® Network (Change of Workflow, Increase of Flexibility) [ Time Frame: Baseline to max. 12 months ]
- Time and Cost Savings for Patients [ Time Frame: Baseline to max. 12 months ]
- Time and Costs Savings for Physicians [ Time Frame: Baseline to max. 12 months ]
- Efficiency Through Increased Flexibility and Per Procedure Time [ Time Frame: Baseline to max. 12 months ]
- Handling of Unscheduled Activities (for Example, Symptoms and Events) [ Time Frame: Baseline to max. 12 months ]"Investigators were asked to classify reasons for unscheduled visits by marking all applicable answers. Answer: 1) patient symptoms 2) adequate therapy/shock 3) appearance of already known arrythmias 4) appearance of new arrythmias 5) need for reprogramming 6) in house Follow-up 7) device alert 8) inadequate therapy/shock 9) worsening of pump function 10) malfunction of the device 11) other"
|Study Start Date:||January 2010|
|Study Completion Date:||October 2013|
|Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
Medtronic CareLink® Network
Patients with implanted Implantable Cardioverter-Defibrillator (ICD) or Cardiac Resynchronization Therapy Defibrillator (CRT-D) devices, who will be monitored by the Medtronic CareLink® System.
The System consists of the Medtronic CareLink® Monitor and Medtronic CareLink® Clinician Website.
Other: Medtronic CareLink® Network
The Medtronic CareLink® Network consists of the Medtronic CareLink® Monitor and Medtronic CareLink® Clinician Website
Comparison of remote device check and in-clinic device assessment. To assess patient ease of use of, and satisfaction with, the Medtronic CareLink® Monitor To assess clinician ease of use of, and satisfaction with, the Medtronic CareLink® Monitor and Website To assess the clinic specific clinical value of Medtronic CareLink® Network Demonstrate time savings for patients Demonstrate time savings for physicians To show the increase of efficiency through increased flexibility and per procedure time To demonstrate better handling of unscheduled activities (symptoms, events, etc.)
Please refer to this study by its ClinicalTrials.gov identifier: NCT01023022
|John Paul II Hospital, Clinic of Electrocardiology|
|The University Hospital in Krakow; I Department of Cardiology|
|I Cardiology Clinic, Clinical University Center|
|I Department of Cardiology, Medical University in Poznan|
|Cardiology Clinic, Pomeranian Medical University SPSK-2|
|Public Independent Central Clinical Hospital - SP-CSK|
|The Cardinal Stefan Wyszynski Institute of Cardiology, 2nd Department of Coronary Artery Disease|
|The Cardinal Stefan Wyszynski Institute of Cardiology, Cardiac Arrhythmias Department|
|4th Military Clinical Hospital, Clinic of Cardiology|
|Silesian Medical University, Silesian Center for Heart Diseases, Clinic of Cardiology, Department of Cardiology and Inborn Defects of Heart and Electrotherapy|
|Principal Investigator:||Hanna Szwed, Prof.||Institute of Cardiology, Warsaw, Poland, Spartanska 1|