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Telemonitoring in Patients With Heart Failure

Telemonitoring in Patients With Heart Failure

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00502255
Acronym
TEHAF2
Enrollment
382
Registered
2007-07-17
Start date
2007-10-31
Completion date
2013-12-31
Last updated
2015-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Failure, Congestive

Keywords

Telemonitoring, Cost-effectiveness, Heart failure, Case management

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.

Interventions

DEVICEHealth Buddy system

Patients are followed on distance by the Health Buddy system.

DEVICETelemonitoring in patients with heart failure

Health Buddy in patients home situation.

Sponsors

Maastricht University
CollaboratorOTHER
Maastricht University Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
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
To what extent will the amount of planned contacts decrease without an increase of unplanned contacts?one year

Secondary

MeasureTime frame
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

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026