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Telemonitoring in Patients With Heart Failure (TEHAF2)

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ClinicalTrials.gov Identifier: NCT00502255
Recruitment Status : Completed
First Posted : July 17, 2007
Last Update Posted : April 8, 2015
Sponsor:
Collaborator:
Maastricht University
Information provided by (Responsible Party):
Josiane Boyne, Maastricht University Medical Center

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.

Condition or disease Intervention/treatment Phase
Heart Failure, Congestive Device: Health Buddy system Device: Telemonitoring in patients with heart failure Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 382 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Telemonitoring in Patients With Heart Failure
Study Start Date : October 2007
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure
U.S. FDA Resources

Arm Intervention/treatment
Experimental: telemonitoring
Health Buddy in patients home situation
Device: Health Buddy system
Patients are followed on distance by the Health Buddy system.
Other Names:
  • TEHAF study
  • Therapy compliance in patients with heart failure
  • Cost effectiveness
Experimental: usual care
patients receive care as usual
Device: Telemonitoring in patients with heart failure
Health Buddy in patients home situation.
Other Name: TEHAf study



Primary Outcome Measures :
  1. To what extent does the use of Health Buddy result in a decrease in hospital admissions? [ Time Frame: one year ]
  2. To what extent is Health Buddy® more cost-effective than usual care? [ Time Frame: one year ]
  3. To what extent will the amount of planned contacts decrease without an increase of unplanned contacts? [ Time Frame: one year ]

Secondary Outcome Measures :
  1. 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 ]
  2. To what extent is it - based on patients' characteristics - possible to identify patient with benefits? [ Time Frame: one year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00502255


Locations
Netherlands
Atrium Medische Centrum
Heerlen, Limburg, Netherlands
Maastricht University Hospital
Maastricht, Limburg, Netherlands, 6202 AZ
Orbis Medische en Zorgconcern
Sittard, Limburg, Netherlands
Sponsors and Collaborators
Maastricht University Medical Center
Maastricht University
Investigators
Study Chair: Hubertus J Vrijhoef, Dr University Maastricht

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Josiane Boyne, RN,MA, Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT00502255     History of Changes
Other Study ID Numbers: 072036
First Posted: July 17, 2007    Key Record Dates
Last Update Posted: April 8, 2015
Last Verified: April 2015

Keywords provided by Josiane Boyne, Maastricht University Medical Center:
Telemonitoring
Cost-effectiveness
Heart failure
Case management

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases