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One Heart to Care for

NCT04753398 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2021-02-15

No results posted yet for this study

Summary

This is an open randomized clinical trial with two study arms. One group, receiving usual care for heart failure, will be compared to another group, receiving usual care plus active telemonitoring interference.

When leaving the hospital, the usual care arm receives a document with a predefined medication scheme and advice for the general practitioner (like it is currently done in usual care). Besides the normal consultations at 2 and 5 weeks, no active interactions take place between the study nurse and the patient.

The telemonitoring interference in the other study arm consists of an automatic blood pressure device and medication dispenser that transmit data to a central platform. During the first 12 weeks, the nurse of the call center will give incentive for medication up titration on the basis of the available data. Before up titration can be done, the patient needs to take blood pressure measurements 3 times in the morning and 3 times in the evening and at least 6 measurements a week.

Conditions

Interventions

DEVICE

Blood Pressure Monitor, medication dispenser, telemonitoring technology

The telemonitoring interference in the telemonitoring arm consists of an automatic blood pressure device and medication dispenser that transmit data to a central platform.

Sponsors & Collaborators

  • Ziekenhuis Oost-Limburg

    collaborator OTHER

  • WGK Limburg

    collaborator UNKNOWN

  • Hasselt University

    lead OTHER

Principal Investigators

  • Pieter Vandervoort, prof. dr. · Ziekenhuis Oost-Limburg

  • Brenda Aendekerk, MSc · Wit Gele Kruis Limburg, Genk, Belgium

  • Valerie Storms, dr. · Hasselt University

  • Lars Grieten, dr. · Hasselt University

  • Christophe Smeets, MSc · Hasselt University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2015-12-31
Completion
2016-12-31

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04753398 on ClinicalTrials.gov