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
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