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

Hasselt University

Status: Completed

Conditions: Telemonitoring in Coronary Artery Disease

Treatments: Other: Telemonitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT03171038

Jessa Hospital

Details and patient eligibility

About

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 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.

Enrollment: 160 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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160 participants in 2 patient groups

Telemonitoring group

Experimental group

Description:

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

Treatment:

Other: Telemonitoring

Usual care group

No Intervention group

Description:

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