Clinical trial NCT00502255: Telemonitoring in Patients With Heart Failure
Official title: Telemonitoring in Patients With Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure, Congestive
Keywords: Telemonitoring
Cost-effectiveness
Heart failure
Case management
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Maastricht University
First posted: 2007-07-17
Enrollment: 382
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


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.

Primary outcomes:
measure: To what extent does the use of Health Buddy result in a decrease in hospital admissions?
timeFrame: one year
measure: To what extent is Health Buddy® more cost-effective than usual care?
timeFrame: one year
measure: To what extent will the amount of planned contacts decrease without an increase of unplanned contacts?
timeFrame: one year
Secondary outcomes:
measure: 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?
timeFrame: one year
measure: To what extent is it - based on patients' characteristics - possible to identify patient with benefits?
timeFrame: one year
Other outcomes:
Locations:
city: Heerlen
country: Netherlands
facility: Atrium Medische Centrum
state: Limburg
city: Maastricht
country: Netherlands
facility: Maastricht University Hospital
state: Limburg
city: Sittard
country: Netherlands
facility: Orbis Medische en Zorgconcern
state: Limburg
Study officials:
affiliation: University Maastricht
name: Hubertus J Vrijhoef, Dr
role: STUDY_CHAIR
References:
citation: Boyne JJ, Vrijhoef HJ, Crijns HJ, De Weerd G, Kragten J, Gorgels AP; TEHAF investigators. Tailored telemonitoring in patients with heart failure: results of a multicentre randomized controlled trial. Eur J Heart Fail. 2012 Jul;14(7):791-801. doi: 10.1093/eurjhf/hfs058. Epub 2012 May 15.
citation: Boyne JJ, Vrijhoef HJ, Wit Rd, Gorgels AP. Telemonitoring in patients with heart failure, the TEHAF study: Study protocol of an ongoing prospective randomised trial. Int J Nurs Stud. 2011 Jan;48(1):94-9. doi: 10.1016/j.ijnurstu.2010.05.017. Epub 2010 Jul 7.