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Health Economic Evaluation of Remote Follow up for Implantable Cardioverter Defibrillator (ICD) Patients (TARIFF)

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ClinicalTrials.gov Identifier: NCT01075516
Recruitment Status : Completed
First Posted : February 25, 2010
Results First Posted : March 3, 2021
Last Update Posted : March 3, 2021
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Devices

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Complication of Cardiac Defibrillator
Enrollment 209
Recruitment Details  
Pre-assignment Details The sample size defined at least 100 pts per arm. The protocol allows few patients over in each of the 2 arms.
Arm/Group Title Standard Follow Up Remote Follow Up
Hide Arm/Group Description ICD patients followed through periodic in-hospital visits ICD patients followed with remote transmitters (Merlin@Home) that periodically communicate correct system functioning
Period Title: Overall Study
Started 107 102
Completed 89 86
Not Completed 18 16
Reason Not Completed
Death             5             9
Lost to Follow-up             10             2
Withdrawal by Subject             3             5
Arm/Group Title Standard Follow-Up Remote Follow-Up Total
Hide Arm/Group Description Implantable cardioverter defibrillators (ICD) patients followed through periodic in-hospital visits ICD patients followed with remote transmitters (Merlin@Home) that periodically communicate correct system functioning Total of all reporting groups
Overall Number of Baseline Participants 107 102 209
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 107 participants 102 participants 209 participants
68.9  (11.5) 69.7  (10.2) 69.3  (10.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 107 participants 102 participants 209 participants
Female
15
  14.0%
16
  15.7%
31
  14.8%
Male
92
  86.0%
86
  84.3%
178
  85.2%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment   [1] 
Measure Type: Number
Unit of measure:  Participants
Italy Number Analyzed 107 participants 102 participants 209 participants
107 102 209
[1]
Measure Description: All Subjects enrolled in Italian centers. Number of subjects
Implant Indication  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 107 participants 102 participants 209 participants
Primary Prevention
83
  77.6%
82
  80.4%
165
  78.9%
Secondary Precention
24
  22.4%
20
  19.6%
44
  21.1%
New York Heart Association (NYHA)   [1] 
Measure Type: Number
Unit of measure:  Participants
I Number Analyzed 107 participants 102 participants 209 participants
25 30 55
II Number Analyzed 107 participants 102 participants 209 participants
51 33 84
III Number Analyzed 107 participants 102 participants 209 participants
28 38 66
IV Number Analyzed 107 participants 102 participants 209 participants
3 1 4
[1]
Measure Description: Count of participants in each grade. "NYHA Functional Class provides a classification of heart failure based on symptomatic limitations to activities of daily living and ranges from NYHA Functional Class I to IV: NYHA Functional Class I is defined as no limitations in physical activity and NYHA Functional Class IV is defined as the presence of heart failure symptoms resulting in inability to carry out any physical activity without discomfort
ejection fraction (EF)%   [1] 
Mean (Standard Deviation)
Unit of measure:  Percentage of blood
Number Analyzed 107 participants 102 participants 209 participants
32.2  (10.6) 31.8  (9.6) 32.0  (10.1)
[1]
Measure Description: EF% is an Echo derived measurements in percentage
1.Primary Outcome
Title Economic Impact of Remote Monitoring on Hospitals and Patients
Hide Description Costs analysis of remote monitoring using Merlin@home and Merlin.net compared to standard follow-up in an Italian real-life setting. Overall mean annual cost per patient: Health Care System (HCS) perspective.
Time Frame 12 months follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Follow Up Remote Follow Up
Hide Arm/Group Description:
ICD patients followed through periodic in-hospital visits
ICD patients followed with remote transmitters (Merlin@Home) that periodically communicate correct system functioning
Overall Number of Participants Analyzed 89 86
Mean (Standard Deviation)
Unit of Measure: Euro (€)
1044.89  (1990.47) 482.87  (2488.10)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard Follow Up, Remote Follow Up
Comments [Not Specified]
Type of Statistical Test Other
Comments Continuous data summarized as mean ± Standard Deviation (SD). For cost data Wilcoxon rank-sum test was used to compare costs across groups. The analysis evaluated HCS perspective of group membership impact (SC vs RM) on total health care cost, adjusting for covariates that were significantly different between the groups at the .2 significance level. Differences between the 2 groups were assessed using differences in sample means (point estimates) and t distributions (confidence intervals)
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Secondary Outcome
Title Impact of Remote Monitoring on Procedural Costs for the Italian Health Economic System (SSN)
Hide Description Comparison of Cardiovascular Hospitalizations costs for the Italian Health Economic System derived from the use of Merlin@Home system versus standard in clinic follow-up
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Standard Follow Up Remote Follow Up
Hide Arm/Group Description:
ICD patients followed through periodic in-hospital visits
ICD patients followed with remote transmitters (Merlin@Home) that periodically communicate correct system functioning
Overall Number of Participants Analyzed 89 86
Mean (Standard Deviation)
Unit of Measure: Euro (€)
886.67  (1979.13) 432.34  (2487.86)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard Follow Up, Remote Follow Up
Comments [Not Specified]
Type of Statistical Test Other
Comments Continuous data are summarized as mean ± SD. For cost data the Wilcoxon rank-sum test was used to compare costs across groups. This analysis evaluated the impact of group membership (SC vs RM) on cardiovascular hospitalization timeframe (outcome), adjusting for covariates that were significantly different between the groups at the .2 significance level. Differences between the 2 groups were assessed using differences in sample means (point estimates) and t distributions (confidence intervals).
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
3.Secondary Outcome
Title Impact of Remote Monitoring on Patients' Quality of Life
Hide Description

Evaluation of patient quality of life through Quality of Life (EQ-5D) questionnaire during follow up with/without using Merlin@Home system.

Utility (patients' preferences) and Quality-adjusted life-year (QALY) scales were used. QALYs were based on utility, the EuroQoL EQ-5D-3L questionnaire was administered to each patient at baseline and at 12 months in order to calculate utility values (both ranges from 0 to 1). High score means better outcomes.

One quality-adjusted life-year (QALY) is equal to 1 year of life in perfect health. QALYs are calculated by estimating the years of life remaining for a patient following a particular treatment or intervention and weighting each year with a quality-of-life score (on a 0 to 1 scale).

Time Frame baseline, 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
The clinical benefit for patients were evaluated through EQ-5D questionnaire. The results of the questionnaire were used to measure the quality-adjusted life years (QALY). It was considered costs and EQ-5D values only for the patients alive who completed the questionnaires (87 SC and 79 RM).
Arm/Group Title Standard Follow Up Remote Follow Up
Hide Arm/Group Description:
ICD patients followed through periodic in-hospital visits
ICD patients followed with remote transmitters (Merlin@Home) that periodically communicate correct system functioning
Overall Number of Participants Analyzed 87 79
Mean (Standard Deviation)
Unit of Measure: score on a scale
Utility at baseline 0.8621  (0.1853) 0.8686  (0.1342)
Utility at 12 months 0.8463  (0.1846) 0.8703  (0.1618)
Quality Adjusted Life Years (Method 1) 0.8542  (0.1689) 0.8694  (0.1329)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard Follow Up, Remote Follow Up
Comments For the patient perspective, the quality of life associated with the 2 strategies was assessed. Quality of life is reported as utility values from the EuroQoL Group 5-Dimension 3-Level Self-Report (EQ-5D-3L) questionnaire and quality adjusted life years (QALYs) were based on utility (patients' preferences). The EQ-5D-3L questionnaire was administered to each patient at baseline and at 12 months in order to calculate utility values (from 0 to 1).
Type of Statistical Test Other
Comments Continuous data are summarized as mean ± SD. This analysis evaluated the impact of group membership (SC vs RM) on total health care cost (outcome), adjusting for covariates that were significantly different between the groups at the .2 significance level. However, as the arithmetic mean is the most informative measurement for policy decisions, differences between the 2 groups were assessed using differences in sample means (point estimates) and t distributions (confidence intervals).
Statistical Test of Hypothesis P-Value 0.80
Comments Comparison of utility at baseline from the EQ-5D-3L questionnaire.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Standard Follow Up, Remote Follow Up
Comments For the patient perspective, the quality of life associated with the 2 strategies was assessed. Quality of life is reported as utility values from the EQ-5D-3L questionnaire and quality adjusted life years (QALYs) were based on utility (patients' preferences). The EQ-5D-3L questionnaire was administered to each patient at baseline and at 12 months in order to calculate utility values (from 0 to 1).
Type of Statistical Test Other
Comments Continuous data are summarized as mean ± SD. This analysis evaluated the impact of group membership (SC vs RM) on total health care cost (outcome), adjusting for covariates that were significantly different between the groups at the .2 significance level. However, as the arithmetic mean is the most informative measurement for policy decisions, differences between the 2 groups were assessed using differences in sample means (point estimates) and t distributions (confidence intervals).
Statistical Test of Hypothesis P-Value 0.38
Comments Comparison of utility at 12 months from the EQ-5D-3L questionnaire.
Method t-test, 2 sided
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Standard Follow Up, Remote Follow Up
Comments For the patient perspective, the quality of life associated with the 2 strategies was assessed. Quality of life is reported as utility values from the EQ-5D-3L questionnaire and quality adjusted life years (QALYs) were based on utility (patients' preferences). The EQ-5D-3L questionnaire was administered to each patient at baseline and at 12 months in order to calculate utility values (from 0 to 1).
Type of Statistical Test Other
Comments Continuous data are summarized as mean ± SD. This analysis evaluated the impact of group membership (SC vs RM) on total health care cost (outcome), adjusting for covariates that were significantly different between the groups at the .2 significance level. However, as the arithmetic mean is the most informative measurement for policy decisions, differences between the 2 groups were assessed using differences in sample means (point estimates) and t distributions (confidence intervals).
Statistical Test of Hypothesis P-Value 0.53
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Standard Follow Up Remote Follow Up
Hide Arm/Group Description ICD patients followed through periodic in-hospital visits ICD patients followed with remote transmitters (Merlin@Home) that periodically communicate correct system functioning
All-Cause Mortality
Standard Follow Up Remote Follow Up
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Standard Follow Up Remote Follow Up
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   21/107 (19.63%)      34/102 (33.33%)    
Cardiac disorders     
Coronary Artery Disease  1  0/107 (0.00%)  0 1/102 (0.98%)  1
Heart Failure  1  8/107 (7.48%)  10 3/102 (2.94%)  3
General disorders     
Cardiac Death  1  0/107 (0.00%)  0 3/102 (2.94%)  3
Death  1  2/107 (1.87%)  2 2/102 (1.96%)  2
Unknown cause of death  1  3/107 (2.80%)  3 4/102 (3.92%)  4
Immune system disorders     
Colitis ulcerative  1  1/107 (0.93%)  1 0/102 (0.00%)  0
Infections and infestations     
Infection  1  0/107 (0.00%)  0 1/102 (0.98%)  1
Injury, poisoning and procedural complications     
Implant site infection  1  0/107 (0.00%)  0 1/102 (0.98%)  1
Pocket formation of decubitus  1  2/107 (1.87%)  2 2/102 (1.96%)  3
Subdural Hematoma  1  1/107 (0.93%)  1 0/102 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Motor disfunction  1  0/107 (0.00%)  0 1/102 (0.98%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Basal cell carcinoma  1  0/107 (0.00%)  0 1/102 (0.98%)  1
Prostatic neoplasm  1  0/107 (0.00%)  0 1/102 (0.98%)  1
Renal Cancer  1  1/107 (0.93%)  1 1/102 (0.98%)  1
Nervous system disorders     
Cerebrovascular accident  1  0/107 (0.00%)  0 1/102 (0.98%)  1
Ischemic stroke  1  0/107 (0.00%)  0 1/102 (0.98%)  1
Product Issues     
Device inappropriate shock delivery  1  1/107 (0.93%)  1 3/102 (2.94%)  4
Device stimulation issue  1  0/107 (0.00%)  0 1/102 (0.98%)  1
Lead dislodgement  1  3/107 (2.80%)  3 6/102 (5.88%)  11
Device malfunction  1  1/107 (0.93%)  1 0/102 (0.00%)  0
Renal and urinary disorders     
Renal failure  1  0/107 (0.00%)  0 1/102 (0.98%)  1
Surgical and medical procedures     
Cardiac pacemaker insertion  1  0/107 (0.00%)  0 2/102 (1.96%)  2
Cardioversion  1  3/107 (2.80%)  3 2/102 (1.96%)  2
Hospitalization  1  2/107 (1.87%)  2 4/102 (3.92%)  5
Medical device repositioning  1  0/107 (0.00%)  0 1/102 (0.98%)  1
Mitral Valve replacement  1  0/107 (0.00%)  0 1/102 (0.98%)  1
Cardiovascular event prophylaxis  1  1/107 (0.93%)  1 0/102 (0.00%)  0
Vascular disorders     
Aortic Aneurysm  1  0/107 (0.00%)  0 1/102 (0.98%)  1
Arterial disorder  1  1/107 (0.93%)  1 0/102 (0.00%)  0
Peripheral ischemia  1  3/107 (2.80%)  3 0/102 (0.00%)  0
Syncope  1  0/107 (0.00%)  0 1/102 (0.98%)  1
Hemorrage  1  0/107 (0.00%)  0 1/102 (0.98%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Standard Follow Up Remote Follow Up
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   18/107 (16.82%)      18/102 (17.65%)    
Cardiac disorders     
Atrial fibrillation  1  1/107 (0.93%)  1 0/102 (0.00%)  0
Heart Failure  1  3/107 (2.80%)  3 1/102 (0.98%)  1
Ventricular tachycardia  1  1/107 (0.93%)  1 0/102 (0.00%)  0
Eye disorders     
Eye symptoms  1  2/107 (1.87%)  3 0/102 (0.00%)  0
Injury, poisoning and procedural complications     
Fall  1  1/107 (0.93%)  1 0/102 (0.00%)  0
Investigations     
Blood pressure dicreased  1  0/107 (0.00%)  0 1/102 (0.98%)  1
Product Issues     
Device capturing issue  1  0/107 (0.00%)  0 2/102 (1.96%)  2
Device electrical impedence issue  1  0/107 (0.00%)  0 1/102 (0.98%)  1
Device inappropriate shock delivery  1  3/107 (2.80%)  4 0/102 (0.00%)  0
Device malfunction  1  1/107 (0.93%)  1 1/102 (0.98%)  1
Device pacing issue  1  4/107 (3.74%)  6 5/102 (4.90%)  5
Device stimulation issue  1  2/107 (1.87%)  4 2/102 (1.96%)  2
Device telemetry issue  1  0/107 (0.00%)  0 5/102 (4.90%)  5
Oversensing  1  2/107 (1.87%)  2 1/102 (0.98%)  1
Undersensing  1  0/107 (0.00%)  0 1/102 (0.98%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Renato P. Ricci
Organization: Department of Cardiology, San Filippo Neri Hospital - Rome
EMail: renatopietroricci@tin.it
Other Publications:
Layout table for additonal information
Responsible Party: Abbott Medical Devices
ClinicalTrials.gov Identifier: NCT01075516    
Other Study ID Numbers: CR 09 021 IT RC
First Submitted: February 2, 2010
First Posted: February 25, 2010
Results First Submitted: June 9, 2020
Results First Posted: March 3, 2021
Last Update Posted: March 3, 2021