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
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
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
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
Learn more about this trial
The TElemonitoring in the Management of Heart Failure (TEMA-HF) 1 Long-term Follow-up Study
We'll reach out to this number within 24 hrs