Telemonitoring in Patients With Heart Failure

Heart Failure, Congestive Clinical Trial

— TEHAF2  

Official title:

Telemonitoring in Patients With Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00502255
• Other study ID #: 072036
• Status: Completed
• Phase: N/A
• First received: July 16, 2007
• Last updated: April 7, 2015
• Start date: October 2007
• Est. completion date: December 2013

Study information

• Verified date: April 2015
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 382
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure, Congestive

Intervention

Device:
• Health Buddy system
Patients are followed on distance by the Health Buddy system.
• Telemonitoring in patients with heart failure
Health Buddy in patients home situation.

Locations

Country	Name	City	State
Netherlands	Atrium Medische Centrum	Heerlen	Limburg
Netherlands	Maastricht University Hospital	Maastricht	Limburg
Netherlands	Orbis Medische en Zorgconcern	Sittard	Limburg

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	Maastricht University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To what extent does the use of Health Buddy result in a decrease in hospital admissions?		one year	No
Primary	To what extent is Health Buddy® more cost-effective than usual care?		one year	No
Primary	To what extent will the amount of planned contacts decrease without an increase of unplanned contacts?		one year	No
Secondary	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	No
Secondary	To what extent is it - based on patients' characteristics - possible to identify patient with benefits?		one year	No