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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Investigator, Outcomes Assessor)
  • Study Primary Completion Date: August 1, 2015

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.

Interventions

  • Other: Telemonitoring

Arms, Groups and Cohorts

  • Experimental: Telemonitoring group
    • 6 months of telemonitoring (t0-t1), followed by usual care up until common long-term stopping date (t1-t2).
  • No Intervention: Usual care group
    • Usual care from t0 up until the common stopping date (t2).

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • 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
  • 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
  • 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
  • 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
  • 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
  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hasselt University
  • Provider of Information About this Clinical Study
    • Principal Investigator: prof. dr. Paul Dendale, Prof. dr. – Hasselt University

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.