Telemonitoring in Patients With Heart Failure

Not Applicable

Completed

• Conditions: Heart Failure, Congestive
• Interventions: Device: Telemonitoring in patients with heart failure; Device: Health Buddy system

• Registration Number: NCT00502255
• Lead Sponsor: Maastricht University Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-07-16
• Study First Submitted QC: 2007-07-16
• Study First Posted: 2007-07-17
• Study Start: 2007-10
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-07
• Last Update Posted: 2015-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 382

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
usual care	Telemonitoring in patients with heart failure	patients receive care as usual
telemonitoring	Health Buddy system	Health Buddy in patients home situation

Primary Outcome Measures

Name	Time	Method
To what extent will the amount of planned contacts decrease without an increase of unplanned contacts?	one year
To what extent does the use of Health Buddy result in a decrease in hospital admissions?	one year
To what extent is Health Buddy® more cost-effective than usual care?	one year

Secondary Outcome Measures

Name	Time	Method
What is the effect of Health Buddy® in patients with heart failure in regard to drug consumption and therapy compliance and level of knowledge, and quality of life?	one year
To what extent is it - based on patients' characteristics - possible to identify patient with benefits?	one year

Trial Locations

Locations (3)

Atrium Medische Centrum; 🇳🇱 Heerlen, Limburg, Netherlands

Orbis Medische en Zorgconcern; 🇳🇱 Sittard, Limburg, Netherlands

Maastricht University Hospital; 🇳🇱 Maastricht, Limburg, Netherlands