Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04376983 |
| Other study ID # |
TELE-CRT1 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2020 |
| Est. completion date |
April 30, 2023 |
Study information
| Verified date |
March 2022 |
| Source |
Hasselt University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The TELE-RCT study is a prospective 2 arm randomized controlled trial recruiting patients
with an implanted CRT device in Jessa Hospital Hasselt in Belgium.
Description:
The TELE-RCT study is a prospective 2 arm randomized controlled trial recruiting patients
with an implanted CRT device in Jessa Hospital Hasselt in Belgium. Subjects that do not
violate any of the exclusion criteria and that have provided informed consent, will be asked
to participate in the study. Patients that enter the study will be randomly assigned in a 1:1
ratio to the intervention or control group. Given the nature of the study, no blinding can be
applied.
A cardiac resynchronization therapy (CRT) device is a battery operated device consisting of a
pulse generator and thin, insulated wires called leads. The device sends electrical impulses
throughout the heart to improve pump activity. This is particularly helpful in patients
suffering from chronic heart failure, given that the pump activity in these patients is
compromised.
Two types of CRT devices exist. On one hand a cardiac resynchronization therapy defibrillator
(CRT-D), which functions as a normal pacemaker but can also sense arrythmias that can lead to
sudden cardiac arrest. The device recognizes these arrhythmias and generates a defibrillation
to stop the abnormal rhythm. On the other hand a cardiac resynchronization therapy pacemaker
(CRT-P), which only functions as a pacemaker.
b. Study population
In order to be enrolled in the TELE-RCT study, subjects must meet all of the following
inclusion criteria:
- Patients with an implanted CRT-D or CRT-P device in which monitoring of physical
activity is possible
- CRT device must be implanted for at least three months
- Dutch speaking and understanding
- Evidence of a personally signed and dated informed consent, indicating that the subject
(or a legally-recognized representative) has been informed of all pertinent aspects of
the study
- Age ≥ 18 years
- CRT capable of transmitting data about physical activity in an interpretable manner
- Willingness and physically able to follow an email-based or SMS-based telemonitoring
program and other study procedures in a 12 weeks follow-up period.
- Clinically stable without inducible ischemia or high-risk ventricular arrhythmia,
confirmed by the last available maximal ergo-spirometry test
- Possession of smartphone or email address, which the patients regularly check, in order
to receive feedback from the research staff
Subjects presenting with any of the following will not be included in the study:
- The presence of an absolute or relative contraindication to moderate- intensity exercise
- Participation in a cardiac revalidation program in the months before enrollment in the
study
- Patients with planned interventional procedure or surgery in next three months
- Present cardiovascular complaints that might interfere with exertion: unstable angina,
recent ICD shock etc.
- Participation in other cardiac rehabilitation program trials, focusing on exercise
outcome
- Orthopedic, neurologic, or any other pathologic condition that makes the patient
physically unable to follow an email-based or SMS-based telemonitoring program
- Any condition, which, in the opinion of the investigator, would make it unsafe or
unsuitable for the patient to participate in this study or a life expectancy of less
than three months based on investigator's judgment
c. Recruitment All patients will be recruited from the department of Cardiology of Jessa
Hospital Hasselt or during the consultations in Heart Center Hasselt. Patients who are
eligible for participation will be contacted by the study staff to obtain further
information. They will receive a brochure which explains the study on one of their
appointments with their cardiologist.
Time schedule: First patient first visit (FPFV): 15th of November 2019 Last patient last
visit (LPLV): 31st of December 2020 4. Study procedures
1. Patient information Eligible participants must sign informed consent prior to undergoing
any study-specific procedures. They will be asked to read, understand and sign the
informed consent form during the first meeting.
At the start of the study, each patient enrolled in the trial will be assigned a unique
identification number in order to ensure the anonymity. In addition, it enables the
researchers to link all collected data (answers to questionnaires, test results etc.) to
the right patient and thus combine the data to gain insight into the results.
2. Randomization The randomization in this study will be varied out with sealed envelopes
to ensure concealed patient allocation. Patients will be randomized to either the
intervention group (group A) or the control group (group B) in a 1:1 ratio. Patients in
group A (intervention group) will receive the standard care for patients with chronic
heart failure at the Jessa Hospital Hasselt, supplemented with regular feedback by email
or SMS about their daily physical activity. Patients in group B (control group) will
only receive the standard care for patients with chronic heart failure at the Jessa
Hospital Hasselt.
3. Intervention Patients in the intervention group (group A) will receive standard care for
patients with chronic heart failure and an implanted CRT device at Jessa Hospital
Hasselt. The standard care consists of half-yearly appointments with a cardiologist and
telemonitoring for arrhythmia. In addition to the standard care, the patients in the
intervention group will also receive regular feedback about their physical activity.
During the first 6 weeks of the trial, the patients in the intervention group will
receive weekly feedback about their daily physical activity. During the following 6
weeks, patients will receive feedback every other week. The feedback will be given by
study staff and will be sent to the patient by email or SMS. The type of feedback a
patient will receive will be based on the minimum required daily physical activity for
patients with chronic heart failure. By looking at previous data, the study staff will
also try to motivate the patient to increase their daily physical activity. The
patiënt's daily physical activity will be telemonitored using the internal accelerometer
of their CRT device. They will be asked to manually transmit the data from their CRT
device to the Jessa Hospital every week.
Patients in the control group (group B) will only receive the standard care Jessa Hospital
Hasselt, being half-yearly appointments with a cardiologist and telemonitoring for
arrhythmia.
