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

Primary Purpose

Telemonitoring in Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Telemonitoring
Sponsored by
Hasselt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Telemonitoring in Coronary Artery Disease focused on measuring Telemonitoring, Chronic Heart Failure, eHealth, Mortality

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Telemonitoring group

    Usual care group

    Arm Description

    6 months of telemonitoring (t0-t1), followed by usual care up until common long-term stopping date (t1-t2).

    Usual care from t0 up until the common stopping date (t2).

    Outcomes

    Primary Outcome Measures

    All-cause mortality
    All-cause mortality

    Secondary Outcome Measures

    days lost due to heart failure readmissions
    days lost due to heart failure readmissions
    days lost due to all readmissions
    days lost due to all readmissions
    days lost due to death or heart failure readmissions
    days lost due to death or heart failure readmissions
    percentage of follow-up time spent in hospital for heart failure
    percentage of follow-up time spent in hospital for heart failure
    percentage of follow-up time spent in hospital for all reasons
    percentage of follow-up time spent in hospital for all reasons
    percentage of follow-up time lost to death or heart failure readmissions
    percentage of follow-up time lost to death or heart failure readmissions

    Full Information

    First Posted
    May 25, 2017
    Last Updated
    May 31, 2017
    Sponsor
    Hasselt University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03171038
    Brief Title
    The TElemonitoring in the Management of Heart Failure (TEMA-HF) 1 Long-term Follow-up Study
    Acronym
    TEMA-HFLT
    Official Title
    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
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    April 1, 2008 (Actual)
    Primary Completion Date
    August 1, 2015 (Actual)
    Study Completion Date
    August 1, 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hasselt University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Telemonitoring in Coronary Artery Disease
    Keywords
    Telemonitoring, Chronic Heart Failure, eHealth, Mortality

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Prospective, multi-center randomized controlled trial
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    160 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Telemonitoring group
    Arm Type
    Experimental
    Arm Description
    6 months of telemonitoring (t0-t1), followed by usual care up until common long-term stopping date (t1-t2).
    Arm Title
    Usual care group
    Arm Type
    No Intervention
    Arm Description
    Usual care from t0 up until the common stopping date (t2).
    Intervention Type
    Other
    Intervention Name(s)
    Telemonitoring
    Primary Outcome Measure Information:
    Title
    All-cause mortality
    Description
    All-cause mortality
    Time Frame
    Start of study to long-term follow-up (6.5 years).
    Secondary Outcome Measure Information:
    Title
    days lost due to heart failure readmissions
    Description
    days lost due to heart failure readmissions
    Time Frame
    Start of study to long-term follow-up (6.5 years).
    Title
    days lost due to all readmissions
    Description
    days lost due to all readmissions
    Time Frame
    Start of study to long-term follow-up (6.5 years).
    Title
    days lost due to death or heart failure readmissions
    Description
    days lost due to death or heart failure readmissions
    Time Frame
    Start of study to long-term follow-up (6.5 years).
    Title
    percentage of follow-up time spent in hospital for heart failure
    Description
    percentage of follow-up time spent in hospital for heart failure
    Time Frame
    Start of study to long-term follow-up (6.5 years).
    Title
    percentage of follow-up time spent in hospital for all reasons
    Description
    percentage of follow-up time spent in hospital for all reasons
    Time Frame
    Start of study to long-term follow-up (6.5 years).
    Title
    percentage of follow-up time lost to death or heart failure readmissions
    Description
    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).

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    29742959
    Citation
    Frederix I, Vanderlinden L, Verboven AS, Welten M, Wouters D, De Keulenaer G, Ector B, Elegeert I, Troisfontaines P, Weytjens C, Mullens W, Dendale P. Long-term impact of a six-month telemedical care programme on mortality, heart failure readmissions and healthcare costs in patients with chronic heart failure. J Telemed Telecare. 2019 Jun;25(5):286-293. doi: 10.1177/1357633X18774632. Epub 2018 May 10.
    Results Reference
    derived

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

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