The TElemonitoring in the Management of Heart Failure (TEMA-HF) 1 Long-term Follow-up Study (TEMA-HFLT)

May 31, 2017 updated by: prof. dr. Paul Dendale, Hasselt University

Long-term Impact of a 6-months Telemedical Care Program on Mortality, Readmissions and Healthcare Costs in Patients With Chronic Heart Failure The TElemonitoring in the Management of Heart Failure (TEMA-HF) 1 Long-term Follow-up Study

TEMA-HF 1 Long-Term Follow-up study is a follow-up study of TEMA-HF 1. It assessed the long-term impact of a 6-months telemonitoring program in chronic heart failure patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The telemonitoring (TM) group patients received a 6-months TM program, followed by standard heart failure care until the long-term follow-up evaluation.

The usual care (UC) patients received ususal care during the first six months, followed by standard heart failure care until the long-term follow-up evaluation.

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Chronic heart failure patients
  • Treated for heart failure according to current guidelines
  • ≥ 18 years of age
  • Able to provide informed consent

Exclusion Criteria:

  • Reversible forms of acute heart failure (myocarditis)
  • Presence of severe aortic stenosis
  • Previous residency in a nursing home
  • Inclusion in a cardiac rehabilitation program on discharge
  • Chronic kidney disease stage ≥ 4
  • Planned dialysis in the next six months
  • Life expectancy < 1 year due to non-heart failure related reasons
  • Severe chronic obstructive pulmonary disease, GOLD ≥ III
  • Cognitive and/or mental problems interfering with the performance of daily measurements and data transmission

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Telemonitoring group
6 months of telemonitoring (t0-t1), followed by usual care up until common long-term stopping date (t1-t2).
Other: Telemonitoring
NO_INTERVENTION: Usual care group
Usual care from t0 up until the common stopping date (t2).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause mortality
Time Frame: Start of study to long-term follow-up (6.5 years).
All-cause mortality
Start of study to long-term follow-up (6.5 years).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
days lost due to heart failure readmissions
Time Frame: Start of study to long-term follow-up (6.5 years).
days lost due to heart failure readmissions
Start of study to long-term follow-up (6.5 years).
days lost due to all readmissions
Time Frame: Start of study to long-term follow-up (6.5 years).
days lost due to all readmissions
Start of study to long-term follow-up (6.5 years).
days lost due to death or heart failure readmissions
Time Frame: Start of study to long-term follow-up (6.5 years).
days lost due to death or heart failure readmissions
Start of study to long-term follow-up (6.5 years).
percentage of follow-up time spent in hospital for heart failure
Time Frame: Start of study to long-term follow-up (6.5 years).
percentage of follow-up time spent in hospital for heart failure
Start of study to long-term follow-up (6.5 years).
percentage of follow-up time spent in hospital for all reasons
Time Frame: Start of study to long-term follow-up (6.5 years).
percentage of follow-up time spent in hospital for all reasons
Start of study to long-term follow-up (6.5 years).
percentage of follow-up time lost to death or heart failure readmissions
Time Frame: Start of study to long-term follow-up (6.5 years).
percentage of follow-up time lost to death or heart failure readmissions
Start of study to long-term follow-up (6.5 years).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hasselt University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2008

Primary Completion (ACTUAL)

August 1, 2015

Study Completion (ACTUAL)

August 1, 2015

Study Registration Dates

First Submitted

May 25, 2017

First Submitted That Met QC Criteria

May 26, 2017

First Posted (ACTUAL)

May 31, 2017

Study Record Updates

Last Update Posted (ACTUAL)

June 1, 2017

Last Update Submitted That Met QC Criteria

May 31, 2017

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Jessa Hospital

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Telemonitoring in Coronary Artery Disease

Clinical Trials on Telemonitoring

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hungary

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe