Integration of Follow-up by First and Second Line Practitioners by Telemonitoring in Heart Failure.

NCT01696890 | Terminated Phase 2 DMC

• 1 other identifier: TEMAHF2
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 7

Brief Summary

The aim of this study is to evaluate this model of telemonitoring-assisted close supervision and interaction between first and second line health professionals versus a model of telemonitoring without this integrated approach.

Conditions

Chronic Heart Failure

Keywords

chronic heart failure; telemonitoring; first line practitioners; integrated approach; efficacy

Outcome Measures

Primary Outcomes (3)

• overall mortality

  6 months

• number of rehospitalizations

  6 months

• time investment by HF nurses

  6 months

Secondary Outcomes (2)

• quality of life

  6 months

• appearance of renal failure (glomerular filtration rate (GFR) <60 mL/min/1.73 m2)

  6 months

Study Arms (2)

integrated care

ACTIVE COMPARATOR

telemonitoring-assisted follow-up with intensive collaboration between general practitioner and specialized Heart failure clinic.

Device: integrated follow-up

standard care

ACTIVE COMPARATOR

telemonitoring- assisted follow-up with usual care by general practitioner, without supervision of heart failure clinic

Device: standard care

Interventions

integrated follow-up DEVICE

close interaction between HF clinic and general practitioner in response to telemonitoring alerts. All subjects will be monitored daily for heart rate, blood pressure, and body weight, after which these data are transferred automatically to the general practitioner. This device is custom-made.

integrated care

standard care DEVICE

no interaction between HF clinic and general practitioner in response to telemonitoring alerts. General practitioner is responsible for adaptations to therapy according to clinical presentation of the patient.

standard care

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients hospitalized for decompensation of systolic heart failure
• LVEF \< 40% during hospitalization.

You may not qualify if:

• reversible forms of acute heart failure (acute ischemia, myocarditis,..)
• heart failure due to severe aortic stenosis
• participation in cardiac rehabilitation after discharge
• previous or actual residency in a nursing home
• creatinine clearance \<15 ml/min
• planned dialysis in the next 6 months
• planned biventricular pacemaker or cardiac surgery
• life expectancy of less than 1 year due to other diseases
• severe obstructive pulmonary disease (Gold III)
• significant mental or cognitive problems interfering with the daily measurements or intake of medication.

Sponsors & Collaborators

• Jessa Hospital: lead

Study Sites (7)

Middelheim Ziekenhuis

Antwerp, Belgium

Location

UZ Brussel

Brussels, Belgium

Location

Ziekenhuis Oost-Limburg

Genk, Belgium

Location

AZ Maria Middelares

Ghent, 9000, Belgium

Location

Jessa Hospital

Hasselt, 3500, Belgium

Location

AZ Groeninge

Kortrijk, Belgium

Location

Chr.Citadelle

Liège, Belgium

Location

Study Officials

• paul dendale, MD, PhD

  Jessa Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof Dr

Study Record Dates

• First Submitted: March 29, 2012
• First Posted: October 1, 2012
• Study Start: October 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: December 1, 2013
• Last Updated: April 7, 2015

Record last verified: 2015-04

Locations

BE (7)