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

Telemonitoring in Coronary Artery Disease Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03171038
• Other study ID #: Jessa Hospital
• Status: Completed
• Phase: N/A
• First received: May 25, 2017
• Last updated: May 31, 2017
• Start date: April 1, 2008
• Est. completion date: August 1, 2015

Study information

• Verified date: May 2017
• Source: Hasselt University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: August 1, 2015
• Est. primary completion date: August 1, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Heart Failure
• Myocardial Ischemia
• Telemonitoring in Coronary Artery Disease

Intervention

Other:
• Telemonitoring

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hasselt University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause mortality	All-cause mortality	Start of study to long-term follow-up (6.5 years).
Secondary	days lost due to heart failure readmissions	days lost due to heart failure readmissions	Start of study to long-term follow-up (6.5 years).
Secondary	days lost due to all readmissions	days lost due to all readmissions	Start of study to long-term follow-up (6.5 years).
Secondary	days lost due to death or heart failure readmissions	days lost due to death or heart failure readmissions	Start of study to long-term follow-up (6.5 years).
Secondary	percentage of follow-up time spent in hospital for heart failure	percentage of follow-up time spent in hospital for heart failure	Start of study to long-term follow-up (6.5 years).
Secondary	percentage of follow-up time spent in hospital for all reasons	percentage of follow-up time spent in hospital for all reasons	Start of study to long-term follow-up (6.5 years).
Secondary	percentage of follow-up time lost to death or heart failure readmissions	percentage of follow-up time lost to death or heart failure readmissions	Start of study to long-term follow-up (6.5 years).