Trial Outcomes & Findings for PORTuguese Research on Telemonitoring With CareLink® (PORTLink) (NCT NCT03125382)

NCT ID: NCT03125382

Last Updated: 2025-07-02

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 141 participants
• Primary outcome timeframe: 12 months visit
• Results posted on: 2025-07-02

Participant Flow

Recruitment start - 01 Apr 2012 Recruitment end - 30 Apr 2015 Location - In Hospital

There were 7 screening failures;

Participant milestones

Measure	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	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	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	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
Randomization STARTED	38	32	37	34
Randomization COMPLETED	37	28	35	34
Randomization NOT COMPLETED	1	4	2	0
Follow-up STARTED	37	28	35	34
Follow-up COMPLETED	35	22	31	31
Follow-up NOT COMPLETED	2	6	4	3

Reasons for withdrawal

Measure	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	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	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	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
Randomization screening failure	1	4	2	0
Follow-up Death	1	2	1	2
Follow-up Lost to Follow-up	1	4	3	1

Baseline Characteristics

PORTuguese Research on Telemonitoring With CareLink® (PORTLink)

Baseline characteristics by cohort

Measure	In Office Standard Visit-New n=37 Participants 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	In Office Standard Visit-Previous n=28 Participants 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	Carelink - New Implants n=35 Participants Patients with new implants who perform device data transmission through Carelink system Carelink System: Patients start to perform device data transmission through Carelink system	Carelink - Previous Implants n=34 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	Total n=134 Participants Total of all reporting groups
Age, Continuous	57.9 years STANDARD_DEVIATION 11.3 • n=5 Participants	62.0 years STANDARD_DEVIATION 15.2 • n=7 Participants	56.5 years STANDARD_DEVIATION 13.7 • n=5 Participants	63.8 years STANDARD_DEVIATION 10.9 • n=4 Participants	59.9 years STANDARD_DEVIATION 13 • n=21 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants	4 Participants n=4 Participants	27 Participants n=21 Participants
Sex: Female, Male Male	30 Participants n=5 Participants	22 Participants n=7 Participants	25 Participants n=5 Participants	30 Participants n=4 Participants	107 Participants n=21 Participants
Type of Device Implantable Cardioverter Defibrillator	26 Participants n=5 Participants	19 Participants n=7 Participants	27 Participants n=5 Participants	24 Participants n=4 Participants	96 Participants n=21 Participants
Type of Device Cardiac Resynchronization Therapy Defibrillator	11 Participants n=5 Participants	9 Participants n=7 Participants	8 Participants n=5 Participants	10 Participants n=4 Participants	38 Participants n=21 Participants

PRIMARY outcome

Timeframe: 12 months visit

Population: Only applicable for Carelink arms

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

Outcome measures

Measure	Carelink - New Implants n=35 Participants Patients with new implants who perform device data transmission through Carelink system Carelink System: Patients start to perform device data transmission through Carelink system	Carelink - Previous Implants n=34 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	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	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
Number of Patient Satisfied or Very Satisfied With Carelink	34 Participants	34 Participants	—	—

SECONDARY outcome

Timeframe: 12 months visit

compare number of Device-related Adverse Events

Outcome measures

Measure	Carelink - New Implants n=37 Participants Patients with new implants who perform device data transmission through Carelink system Carelink System: Patients start to perform device data transmission through Carelink system	Carelink - Previous Implants n=28 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	Carelink - New Implants n=35 Participants Patients with new implants who perform device data transmission through Carelink system Carelink System: Patients start to perform device data transmission through Carelink system	Carelink - Previous Implants n=34 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
Number of Device Related Adverse Events	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 12 months visit

Through the semi-quantitative evaluation of physician satisfaction with CareLink System.

Used rating: "Very Satisfied"; "Satisfied"; "neither satisfied nor dissatisfied"; "dissatisfied" and "very dissatisfied"

Outcome measures

Measure	Carelink - New Implants n=35 Participants Patients with new implants who perform device data transmission through Carelink system Carelink System: Patients start to perform device data transmission through Carelink system	Carelink - Previous Implants n=34 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	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	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
Physician Satisfaction With Carelink: Total Number of Transmissions With Satisfaction Ratings very satisfied	98 satisfaction at each transmission	80 satisfaction at each transmission	—	—
Physician Satisfaction With Carelink: Total Number of Transmissions With Satisfaction Ratings satisfied	25 satisfaction at each transmission	47 satisfaction at each transmission	—	—
Physician Satisfaction With Carelink: Total Number of Transmissions With Satisfaction Ratings neither satisfied nor dissatisfied	0 satisfaction at each transmission	0 satisfaction at each transmission	—	—
Physician Satisfaction With Carelink: Total Number of Transmissions With Satisfaction Ratings dissatisfied	0 satisfaction at each transmission	0 satisfaction at each transmission	—	—
Physician Satisfaction With Carelink: Total Number of Transmissions With Satisfaction Ratings Neither satisfied nor dissatisfied	0 satisfaction at each transmission	0 satisfaction at each transmission	—	—

SECONDARY outcome

Timeframe: 12 months visit

Population: 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

Number of in office unscheduled visits will be calculated per arm and compared with each other

Outcome measures

Measure	Carelink - New Implants n=65 Participants Patients with new implants who perform device data transmission through Carelink system Carelink System: Patients start to perform device data transmission through Carelink system	Carelink - Previous Implants n=69 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	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	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
Health Care Consumed Resources Between Groups Relative to Unscheduled Visits	1.1 visits Standard Deviation 0.9	0.4 visits Standard Deviation 0.6	—	—

SECONDARY outcome

Timeframe: Baseline

Population: 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

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

Outcome measures

Measure	Carelink - New Implants n=64 Participants Patients with new implants who perform device data transmission through Carelink system Carelink System: Patients start to perform device data transmission through Carelink system	Carelink - Previous Implants n=69 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	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	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
Compare Patient Consumed Resources Between Groups Up to 5 €	23 Participants	23 Participants	—	—
Compare Patient Consumed Resources Between Groups 5 - 15 €	21 Participants	26 Participants	—	—
Compare Patient Consumed Resources Between Groups More than 15€	20 Participants	20 Participants	—	—

SECONDARY outcome

Timeframe: Baseline

Population: 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

Patient time consumption in visits between the groups at baseline visit

Arms were combine:

• In office standard visit combined: Office Standard Visit-New + In Office Standard Visit-Previous
• Carelink combine: Carelink - New Implants & Carelink - Previous

Outcome measures

Measure	Carelink - New Implants n=65 Participants Patients with new implants who perform device data transmission through Carelink system Carelink System: Patients start to perform device data transmission through Carelink system	Carelink - Previous Implants n=69 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	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	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
Compare Patient Consumed Resources Between Groups Travel time	30 Minutes Interval 15.0 to 60.0	30 Minutes Interval 20.0 to 60.0	—	—
Compare Patient Consumed Resources Between Groups Time at the hospital	80 Minutes Interval 50.0 to 110.0	95 Minutes Interval 60.0 to 140.0	—	—

SECONDARY outcome

Timeframe: 12 months visit

Population: 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

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.

Outcome measures

Measure	Carelink - New Implants n=65 Participants Patients with new implants who perform device data transmission through Carelink system Carelink System: Patients start to perform device data transmission through Carelink system	Carelink - Previous Implants n=69 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	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	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
Improvement in Quality of Life HADS anxiety	0 score change Interval -3.0 to 0.0	0 score change Interval -3.0 to 1.0	—	—
Improvement in Quality of Life HADS depression	0 score change Interval -2.0 to 1.0	0 score change Interval -2.0 to 1.0	—	—
Improvement in Quality of Life SF12 physical component	-1.1 score change Interval -8.1 to 2.6	0.0 score change Interval -4.5 to 4.9	—	—
Improvement in Quality of Life SF12 mental component	0.4 score change Interval -3.9 to 7.5	0.0 score change Interval -9.5 to 5.6	—	—

SECONDARY outcome

Timeframe: 12 months visit

Population: 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

compare number of Unanticipated Serious Adverse Device Effects (USADE)

Arms were combine:

• In office standard visit combined: Office Standard Visit-New + In Office Standard Visit-Previous
• Carelink combine: Carelink - New Implants & Carelink - Previous

Outcome measures

Measure	Carelink - New Implants n=65 Participants Patients with new implants who perform device data transmission through Carelink system Carelink System: Patients start to perform device data transmission through Carelink system	Carelink - Previous Implants n=69 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	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	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
Number of Unanticipated Serious Adverse Device Effects (USADE) Rate	6 adverse event	4 adverse event	—	—

Adverse Events

In Office Standard Visit-New

Serious events: 1 serious events

Other events: 1 other events

Deaths: 1 deaths

In Office Standard Visit-Previous

Serious events: 2 serious events

Other events: 2 other events

Deaths: 2 deaths

Carelink - New Implants

Serious events: 1 serious events

Other events: 0 other events

Deaths: 1 deaths

Carelink - Previous Implants

Serious events: 2 serious events

Other events: 1 other events

Deaths: 2 deaths

Serious adverse events

Measure	In Office Standard Visit-New n=37 participants at risk 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	In Office Standard Visit-Previous n=28 participants at risk 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	Carelink - New Implants n=35 participants at risk Patients with new implants who perform device data transmission through Carelink system Carelink System: Patients start to perform device data transmission through Carelink system	Carelink - Previous Implants n=34 participants at risk Patients with previous implants who perform device data transmission through Carelink system Carelink System: Patients start to perform device data transmission through Carelink system
Blood and lymphatic system disorders Death	2.7% 1/37 • Number of events 1 • 12 months visit	0.00% 0/28 • 12 months visit	2.9% 1/35 • Number of events 1 • 12 months visit	2.9% 1/34 • Number of events 1 • 12 months visit
Respiratory, thoracic and mediastinal disorders pulmonary edema	0.00% 0/37 • 12 months visit	0.00% 0/28 • 12 months visit	0.00% 0/35 • 12 months visit	2.9% 1/34 • Number of events 1 • 12 months visit
Cardiac disorders Exarcebation chronic kidney disease	0.00% 0/37 • 12 months visit	3.6% 1/28 • Number of events 1 • 12 months visit	0.00% 0/35 • 12 months visit	0.00% 0/34 • 12 months visit
Respiratory, thoracic and mediastinal disorders Pulmonary Embolism	0.00% 0/37 • 12 months visit	3.6% 1/28 • Number of events 1 • 12 months visit	0.00% 0/35 • 12 months visit	0.00% 0/34 • 12 months visit

Other adverse events

Measure	In Office Standard Visit-New n=37 participants at risk 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	In Office Standard Visit-Previous n=28 participants at risk 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	Carelink - New Implants n=35 participants at risk Patients with new implants who perform device data transmission through Carelink system Carelink System: Patients start to perform device data transmission through Carelink system	Carelink - Previous Implants n=34 participants at risk Patients with previous implants who perform device data transmission through Carelink system Carelink System: Patients start to perform device data transmission through Carelink system
Cardiac disorders Ventricular Tachycardia	0.00% 0/37 • 12 months visit	7.1% 2/28 • Number of events 2 • 12 months visit	0.00% 0/35 • 12 months visit	0.00% 0/34 • 12 months visit
Cardiac disorders AF with fast ventricular response	2.7% 1/37 • Number of events 1 • 12 months visit	0.00% 0/28 • 12 months visit	0.00% 0/35 • 12 months visit	0.00% 0/34 • 12 months visit
Cardiac disorders Decompesated cardiac failure episode	0.00% 0/37 • 12 months visit	0.00% 0/28 • 12 months visit	0.00% 0/35 • 12 months visit	2.9% 1/34 • Number of events 1 • 12 months visit

Additional Information

Drª. Milene Fernandes

IMP

Phone: 00351965751328

Email: milenefernandes@hotmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place