Heart Failure, Congestive Clinical Trial
— TEHAF2Official title:
Telemonitoring in Patients With Heart Failure
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.
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. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
Country | Name | City | State |
---|---|---|---|
Netherlands | Atrium Medische Centrum | Heerlen | Limburg |
Netherlands | Maastricht University Hospital | Maastricht | Limburg |
Netherlands | Orbis Medische en Zorgconcern | Sittard | Limburg |
Lead Sponsor | Collaborator |
---|---|
Maastricht University Medical Center | Maastricht University |
Netherlands,
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 |
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