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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00502255
Other study ID # 072036
Secondary ID
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


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
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