Telemonitoring in Patients With Heart Failure (TEHAF2)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Maastricht University
Information provided by (Responsible Party):
Josiane Boyne, Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00502255
First received: July 16, 2007
Last updated: May 2, 2013
Last verified: May 2013
  Purpose

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 Intervention
Heart Failure, Congestive
Device: Health Buddy system
Device: Telemonitoring in patients with heart failure

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Telemonitoring in Patients With Heart Failure

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • To what extent does the use of Health Buddy result in a decrease in hospital admissions? [ Time Frame: one year ] [ Designated as safety issue: No ]
  • To what extent is Health Buddy® more cost-effective than usual care? [ Time Frame: one year ] [ Designated as safety issue: No ]
  • To what extent will the amount of planned contacts decrease without an increase of unplanned contacts? [ Time Frame: one year ] [ Designated as safety issue: No ]

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? [ Time Frame: one year ] [ Designated as safety issue: No ]
  • To what extent is it - based on patients' characteristics - possible to identify patient with benefits? [ Time Frame: one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 382
Study Start Date: October 2007
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by Maastricht University Medical Center

Additional 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
Study First Received: July 16, 2007
Last Updated: May 2, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 24, 2014