NCT04376983

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable heart-failure

Timeline
Completed

Started Mar 2020

Typical duration for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 4, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 6, 2020

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2023

Completed
Last Updated

March 15, 2022

Status Verified

March 1, 2022

Enrollment Period

3 years

First QC Date

May 4, 2020

Last Update Submit

March 14, 2022

Conditions

Heart FailureTelemedicineCardiac Resynchronisation Therapy

Outcome Measures

Primary Outcomes (1)

  • Increase in percentage active minutes per day measured by CRT device

    12 weeks

Secondary Outcomes (4)

  • International Physical Activity Questionnaire

    12 weeks

  • HeartQol questionnaire

    12 weeks

  • Satisfaction: questionnaire

    12 weeks

  • SUS questionnaire

    12 weeks

Study Arms (2)

Control

NO INTERVENTION

Patients will get no intervention

Intervention

EXPERIMENTAL

Patients will transmit their CRT data every week (first 6 weeks) and then every two week to the Heart Centre Hasselt. The physical activity data will be used to deliver a tailored motivational message to the patient to increase physical activity in this group.

Behavioral: Telerehabilitation for patients with a cardiac resynchronisation device

Interventions

Telerehabilitation for patients with a cardiac resynchronisation deviceBEHAVIORAL

Using the device-measured physical activity to create tailored motivational messages and tips to the patients to increase physical activity

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jessa Hospital

Hasselt, Limburg, 3500, Belgium

RECRUITING

MeSH Terms

Conditions

Heart Failure

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesTelemedicineDelivery of Health CarePatient Care ManagementHealth Services Administration

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: RCT
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

May 4, 2020

First Posted

May 6, 2020

Study Start

March 1, 2020

Primary Completion

February 28, 2023

Study Completion

April 30, 2023

Last Updated

March 15, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)