Telemonitoring in Patients With Heart Failure

Study Overview
=================
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.

Official Title
-----------------
Telemonitoring in Patients With Heart Failure

Conditions
-----------------
Heart Failure, Congestive

Intervention / Treatment
-----------------
* Device: Health Buddy system
* Device: Telemonitoring in patients with heart failure


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: telemonitoring<br>Health Buddy in patients home situation | Device: Health Buddy system<br>* Patients are followed on distance by the Health Buddy system.<br>* Other names: Cost effectiveness;|
| Experimental: usual care<br>patients receive care as usual | Device: Telemonitoring in patients with heart failure<br>* Health Buddy in patients home situation.<br>* Other names: TEHAf study;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time 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 Outcome Measures

| Outcome Measure | Measure Description | Time 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Telemonitoring, Cost-effectiveness, Heart failure, Case management