Telemonitoring in Patients With Heart Failure (TEHAF2)

Maastricht University Medical Centre (MUMC)

Status: Completed

Conditions: Heart Failure, Congestive

Treatments: Device: Telemonitoring in patients with heart failure; Device: Health Buddy system

Study type: Interventional

Funder types: Other

Identifiers

NCT00502255

072036

Details and patient eligibility

About

The purpose of this study is to investigate if telemonitoring results in a decrease in hospital admissions, with equal quality of care defined as mortality, quality of life and unplanned visits with caregivers. Telemonitoring is expected to be more cost-effective than usual care in patients with heart failure.

Enrollment: 382 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients > 18 years
• Patients with heart failure NYHA classification II-III-IV
• Patient experienced a period of fluid retention
• Patient is treated by a cardiologist
• Patient is followed-up by a heart failure nurse
• Adequate knowledge of the Dutch language
• Patient has an active telephone connection, preferably analogue
• Patient is mental competent
• Patient has the disposal of a balance

Exclusion criteria

• Patients suffering from COPD, Gold classification 3 or 4
• Patient is a dialysis patient
• Patient has a visual restriction to read the dialogues on the Health Buddy
• Patient is hard of hearing or deaf
• Patient suffers from a lethal sickness with a prognosis < 1 year
• Patient participates in another trial
• Patient needs a hospital admission on short time, i.e., < 3 months
• Patient used the Health Buddy in an earlier stage
• Patient is an illiterate person.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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382 participants in 2 patient groups

telemonitoring

Experimental group

Description:

Health Buddy in patients home situation

Treatment:

Device: Health Buddy system

usual care

Experimental group

Description:

patients receive care as usual

Treatment:

Device: Telemonitoring in patients with heart failure