Back to resultsTelemonitoring in Patients With Heart Failure (TEHAF2)
Primary Purpose
Heart Failure, Congestive
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Health Buddy system
Telemonitoring in patients with heart failure
Sponsored by
About this trial
This is an interventional health services research trial for Heart Failure, Congestive focused on measuring Telemonitoring, Cost-effectiveness, Heart failure, Case management
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.
Sites / Locations
- Atrium Medische Centrum
- Maastricht University Hospital
- Orbis Medische en Zorgconcern
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
telemonitoring
usual care
Arm Description
Health Buddy in patients home situation
patients receive care as usual
Outcomes
Primary Outcome Measures
To what extent does the use of Health Buddy result in a decrease in hospital admissions?
To what extent is Health Buddy® more cost-effective than usual care?
To what extent will the amount of planned contacts decrease without an increase of unplanned contacts?
Secondary Outcome Measures
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?
To what extent is it - based on patients' characteristics - possible to identify patient with benefits?
Full Information
NCT ID
NCT00502255
First Posted
July 16, 2007
Last Updated
April 7, 2015
Sponsor
Maastricht University Medical Center
Collaborators
Maastricht University
1. Study Identification
Unique Protocol Identification Number
NCT00502255
Brief Title
Telemonitoring in Patients With Heart Failure
Acronym
TEHAF2
Official Title
Telemonitoring in Patients With Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maastricht University Medical Center
Collaborators
Maastricht University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Congestive
Keywords
Telemonitoring, Cost-effectiveness, Heart failure, Case management
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
382 (Actual)
8. Arms, Groups, and Interventions
Arm Title
telemonitoring
Arm Type
Experimental
Arm Description
Health Buddy in patients home situation
Arm Title
usual care
Arm Type
Experimental
Arm Description
patients receive care as usual
Intervention Type
Device
Intervention Name(s)
Health Buddy system
Other Intervention Name(s)
TEHAF study, Therapy compliance in patients with heart failure, Cost effectiveness
Intervention Description
Patients are followed on distance by the Health Buddy system.
Intervention Type
Device
Intervention Name(s)
Telemonitoring in patients with heart failure
Other Intervention Name(s)
TEHAf study
Intervention Description
Health Buddy in patients home situation.
Primary Outcome Measure Information:
Title
To what extent does the use of Health Buddy result in a decrease in hospital admissions?
Time Frame
one year
Title
To what extent is Health Buddy® more cost-effective than usual care?
Time Frame
one year
Title
To what extent will the amount of planned contacts decrease without an increase of unplanned contacts?
Time Frame
one year
Secondary Outcome Measure Information:
Title
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?
Time Frame
one year
Title
To what extent is it - based on patients' characteristics - possible to identify patient with benefits?
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hubertus J Vrijhoef, Dr
Organizational Affiliation
University Maastricht
Official's Role
Study Chair
Facility Information:
Facility Name
Atrium Medische Centrum
City
Heerlen
State/Province
Limburg
Country
Netherlands
Facility Name
Maastricht University Hospital
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6202 AZ
Country
Netherlands
Facility Name
Orbis Medische en Zorgconcern
City
Sittard
State/Province
Limburg
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
22588319
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.
Results Reference
derived
PubMed Identifier
20615505
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.
Results Reference
derived
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Telemonitoring in Patients With Heart Failure
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