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Compare use of Carelink system - monitoring system - with traditional in-clinic follow up, in patients with implantable cardiac defibrillator (ICD)
The objective of the PORTLink (PORTuguese Research on Telemonitoring with CareLink), a multicenter randomized study, is to assess the safety, functioning and costs of remote ICD monitoring when compared to traditional in-clinic follow-up. It will evaluate aspects such as the clinician and patient acceptance and satisfaction with the reviewing device data via the website, the complexity for troubleshooting calls to the support center, the utilization of emergency resources by symptomatic patients, the percentage of the unscheduled appointments after a remote interrogation, the levels of anxiety, depression and quality of life, and the main consumed resources with CareLink System.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| In office standard visit-New | Active Comparator | Patients with new implants who do not perform device data transmission through Carelink system |
|
| In office standard visit-Previous | Active Comparator | Patients with previous implants who do not perform device data transmission through Carelink system |
|
| Carelink - New Implants | Experimental | Patients with new implants who perform device data transmission through Carelink system |
|
| Carelink - Previous Implants | Experimental | Patients with previous implants who perform device data transmission through Carelink system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carelink System | Device | Patients start to perform device data transmission through Carelink system |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patient Satisfied or Very Satisfied With Carelink | through the semi-quantitative evaluation of patient satisfaction with Carelink System and their preference when compared to traditional in-clinic follow-up, the options were: 1) Very Satisfied; 2) Satisfied; 3) Not Satisfied nether Unsatisfied; 4) Unsatisfied; 5)Very Unsatisfied | 12 months visit |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Device Related Adverse Events | compare number of Device-related Adverse Events | 12 months visit |
| Physician Satisfaction With Carelink: Total Number of Transmissions With Satisfaction Ratings |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mário Oliveira, Doctor | Centro Hospitalar de Lisboa Central | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Hospitalar do Algarve | Faro | 8000-386 | Portugal | |||
| Centro Hospitalar de Alto Ave - Unidade de Guimarães |
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There were 7 screening failures;
Recruitment start - 01 Apr 2012 Recruitment end - 30 Apr 2015
Location - In Hospital
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| ID | Title | Description |
|---|---|---|
| FG000 | In Office Standard Visit-New | Patients with new implants who do not perform device data transmission through Carelink system In office standard visit: Patients start or maintain in office standard visits |
| FG001 | In Office Standard Visit-Previous | Patients with previous implants who do not perform device data transmission through Carelink system In office standard visit: Patients start or maintain in office standard visits |
| FG002 | Carelink - New Implants | Patients with new implants who perform device data transmission through Carelink system Carelink System: Patients start to perform device data transmission through Carelink system |
| FG003 | Carelink - Previous Implants | Patients with previous implants who perform device data transmission through Carelink system Carelink System: Patients start to perform device data transmission through Carelink system |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Randomization |
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| ||||||||||||||||||
| Follow-up |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | In Office Standard Visit-New | Patients with new implants who do not perform device data transmission through Carelink system In office standard visit: Patients start or maintain in office standard visits |
| BG001 | In Office Standard Visit-Previous |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patient Satisfied or Very Satisfied With Carelink | through the semi-quantitative evaluation of patient satisfaction with Carelink System and their preference when compared to traditional in-clinic follow-up, the options were: 1) Very Satisfied; 2) Satisfied; 3) Not Satisfied nether Unsatisfied; 4) Unsatisfied; 5)Very Unsatisfied | Only applicable for Carelink arms | Posted | Count of Participants | Participants | 12 months visit |
|
12 months visit
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | In Office Standard Visit-New | Patients with new implants who do not perform device data transmission through Carelink system In office standard visit: Patients start or maintain office standard visits |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Blood and lymphatic system disorders | Non-systematic Assessment | unknown death cause |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ventricular Tachycardia | Cardiac disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Drª. Milene Fernandes | IMP | 00351965751328 | milenefernandes@hotmail.com |
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| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| In office standard visit | Device | Patients start or maintain in office standard visits |
|
Through the semi-quantitative evaluation of physician satisfaction with CareLink System.
Used rating: "Very Satisfied"; "Satisfied"; "neither satisfied nor dissatisfied"; "dissatisfied" and "very dissatisfied"
| 12 months visit |
| Health Care Consumed Resources Between Groups Relative to Unscheduled Visits | Number of in office unscheduled visits will be calculated per arm and compared with each other | 12 months visit |
| Compare Patient Consumed Resources Between Groups | Attribute patient travel costs to low, middle and high costs and then compare patient travel costs between the group with in office visits versus Carelink, measured at baseline | Baseline |
| Compare Patient Consumed Resources Between Groups | Patient time consumption in visits between the groups at baseline visit Arms were combine:
| Baseline |
| Improvement in Quality of Life | Health-related quality of life was measured with an adapted version of the SF-12 questionnaire, a 12-item generic measure derived from the Short-Form 36. It evaluates physical functioning, limitations due to physical health problems, bodily pain, energy/fatigue, social functioning, limitations due to emotional problems, and psychological distress and well-being. Physica lcomponent summary and mental component summary measures were estimated, with higher scores indicating better health status (range from 0 to 100). Mental health wellbeing was measured with the Hospital Anxiety and Depression Scale (HADS), which consists of a series of 14 questions, seven related to anxiety (HAD-A) plus other seven questions related to depression (HAD-D). Scores of 0-7 for the two subscales are regarded as normal, scores of 8-10 suggest the presence of a mood disorder and scores ≥11 suggest a probable mood disorder. | 12 months visit |
| Number of Unanticipated Serious Adverse Device Effects (USADE) Rate | compare number of Unanticipated Serious Adverse Device Effects (USADE) Arms were combine:
| 12 months visit |
| Guimarães |
| 4835-044 |
| Portugal |
| Centro Hospitalar Lisboa Central- Hospital de Santa Marta | Lisbon | 1169-1024 | Portugal |
| Centro Hospitalar do Porto | Porto | 4099-001 | Portugal |
| Centro Hospitalar de Setúbal | Setúbal | 2910 - 446 | Portugal |
| Centro Hospitalar Vila Nova de Gaia/Espinho | Vila Nova de Gaia | 4434-502 | Portugal |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Patients with previous implants who do not perform device data transmission through Carelink system In office standard visit: Patients start or maintain in office standard visits |
| BG002 | Carelink - New Implants | Patients with new implants who perform device data transmission through Carelink system Carelink System: Patients start to perform device data transmission through Carelink system |
| BG003 | Carelink - Previous Implants | Patients with previous implants who perform device data transmission through Carelink system Carelink System: Patients start to perform device data transmission through Carelink system |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Type of Device | Count of Participants | Participants |
|
Patients with previous implants who perform device data transmission through Carelink system Carelink System: Patients start to perform device data transmission through Carelink system |
|
|
| Secondary | Number of Device Related Adverse Events | compare number of Device-related Adverse Events | Posted | Count of Participants | Participants | 12 months visit |
|
|
|
| Secondary | Physician Satisfaction With Carelink: Total Number of Transmissions With Satisfaction Ratings | Through the semi-quantitative evaluation of physician satisfaction with CareLink System. Used rating: "Very Satisfied"; "Satisfied"; "neither satisfied nor dissatisfied"; "dissatisfied" and "very dissatisfied" | Posted | Number | satisfaction at each transmission | 12 months visit |
|
|
|
| Secondary | Health Care Consumed Resources Between Groups Relative to Unscheduled Visits | Number of in office unscheduled visits will be calculated per arm and compared with each other | It was pre-specified to combine "In Office Standard Visit-New" and "In Office Standard Visit-Previous" Arms/Groups and "Carelink - New Implants" and "Carelink - Previous Implants" Arms/Groups for this analysis | Posted | Mean | Standard Deviation | visits | 12 months visit |
|
|
|
| Secondary | Compare Patient Consumed Resources Between Groups | Attribute patient travel costs to low, middle and high costs and then compare patient travel costs between the group with in office visits versus Carelink, measured at baseline | It was pre-specified to combine "In Office Standard Visit-New" and "In Office Standard Visit-Previous" Arms/Groups and "Carelink - New Implants" and "Carelink - Previous Implants" Arms/Groups for this analysis | Posted | Count of Participants | Participants | Baseline |
|
|
|
| Secondary | Compare Patient Consumed Resources Between Groups | Patient time consumption in visits between the groups at baseline visit Arms were combine:
| It was pre-specified to combine "In Office Standard Visit-New" and "In Office Standard Visit-Previous" Arms/Groups and "Carelink - New Implants" and "Carelink - Previous Implants" Arms/Groups for this analysis | Posted | Median | Inter-Quartile Range | Minutes | Baseline |
|
|
|
| Secondary | Improvement in Quality of Life | Health-related quality of life was measured with an adapted version of the SF-12 questionnaire, a 12-item generic measure derived from the Short-Form 36. It evaluates physical functioning, limitations due to physical health problems, bodily pain, energy/fatigue, social functioning, limitations due to emotional problems, and psychological distress and well-being. Physica lcomponent summary and mental component summary measures were estimated, with higher scores indicating better health status (range from 0 to 100). Mental health wellbeing was measured with the Hospital Anxiety and Depression Scale (HADS), which consists of a series of 14 questions, seven related to anxiety (HAD-A) plus other seven questions related to depression (HAD-D). Scores of 0-7 for the two subscales are regarded as normal, scores of 8-10 suggest the presence of a mood disorder and scores ≥11 suggest a probable mood disorder. | It was pre-specified to combine "In Office Standard Visit-New" and "In Office Standard Visit-Previous" Arms/Groups and "Carelink - New Implants" and "Carelink - Previous Implants" Arms/Groups for this analysis Within each group, nonparametric Wilcoxon rank-sum test for paired samples was used to determine the statistical significance of changes on anxiety, depression and SF-12 scores. Changes in HADS anxiety and depression scores, SF-12 were evaluated by analysis of covariance (ANCOVA) models | Posted | Mean | 95% Confidence Interval | score change | 12 months visit |
|
|
|
| Secondary | Number of Unanticipated Serious Adverse Device Effects (USADE) Rate | compare number of Unanticipated Serious Adverse Device Effects (USADE) Arms were combine:
| It was pre-specified to combine "In Office Standard Visit-New" and "In Office Standard Visit-Previous" Arms/Groups and "Carelink - New Implants" and "Carelink - Previous Implants" Arms/Groups for this analysis | Posted | Number | adverse event | 12 months visit |
|
|
|
| 1 |
| 37 |
| 1 |
| 37 |
| 1 |
| 37 |
| EG001 | In Office Standard Visit-Previous | Patients with previous implants who do not perform device data transmission through Carelink system In office standard visit: Patients start or maintain in office standard visits | 2 | 28 | 2 | 28 | 2 | 28 |
| EG002 | Carelink - New Implants | Patients with new implants who perform device data transmission through Carelink system Carelink System: Patients start to perform device data transmission through Carelink system | 1 | 35 | 1 | 35 | 0 | 35 |
| EG003 | Carelink - Previous Implants | Patients with previous implants who perform device data transmission through Carelink system Carelink System: Patients start to perform device data transmission through Carelink system | 2 | 34 | 2 | 34 | 1 | 34 |
|
| pulmonary edema | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | resulted in the death |
|
| Exarcebation chronic kidney disease | Cardiac disorders | Non-systematic Assessment | resulted in the death |
|
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | resulted in the death |
|
| AF with fast ventricular response | Cardiac disorders | Non-systematic Assessment |
|
| Decompesated cardiac failure episode | Cardiac disorders | Non-systematic Assessment |
|
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| neither satisfied nor dissatisfied |
|
| dissatisfied |
|
| Neither satisfied nor dissatisfied |
|
| More than 15€ |
|
| SF12 physical component |
|
| SF12 mental component |
|