Integration of Follow-up by First and Second Line Practit... | NCT01696890

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

NCT01696890

Sponsor

Jessa Hospital

Status

Terminated

Last Update Posted

Apr 7, 2015Estimated

Enrollment

50Actual

Phase

Phase 2

Conditions

Chronic Heart Failure

Interventions

integrated follow-up
standard care

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

lack of inclusions, sudden withdrawal of study coordinator

Expanded Access Info

Start Date

Oct 2011

Primary Completion Date

Sep 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

Mar 29, 2012

First Submission Date that Met QC Criteria

Sep 28, 2012

First Posted Date

Oct 1, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 6, 2015

Last Update Posted Date

Apr 7, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

The incidence of acute decompensated heart failure is increasing. Patients with severe heart failure are rehospitalised for decompensation several times each year, increasing the cost for health care. In these cases of recurrent decompensation, the medical intervention in hospital is often limited to increasing the dosage of diuretics or vasodilators until the patient reaches a compensated state. After discharge, a readmission can be expected within a few months. A multidisciplinary approach by primary physician, heart failure nurse, rehabilitation team and cardiologist has been shown to decrease rehospitalisation rate and increase quality of life.

Very recently, our study group showed that an intense collaboration between first line practitioner and heart failure clinic, facilitated by the use of telemonitoring, can reduce mortality and hospitalisation rate. This study was a RIZIV sponsored trial of 6 months follow-up in patients with chronic heart failure. However, a large randomised multicentre trial investigating the use of telemonitoring in a population of heart failure (NYHA II-III) patients did not find any difference between telemonitoring and usual care (Chaudry et al NEJM 2010). In contradiction with this study, a Cochrane meta-analysis (Ingliss 2010) in more than 5000 patients confirmed our finding with a reduction in mortality and morbidity. The question therefore remains which factors are responsible for success or failure of the use of telemonitoring. Based on our previous experience, the approach of close monitoring by telemonitoring, with first line intervention by the patient's general practitioner (GP) and supervision by the heart failure clinic, might be the critical success factor.

Therefore, 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
overall mortality		6 months
number of rehospitalizations		6 months
time investment by HF nurses		6 months

Secondary Outcomes

Measure	Description	Time Frame
quality of life		6 months
appearance of renal failure (glomerular filtration rate (GFR) <60 mL/min/1.73 m2)		6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
paul dendale, MD, PhD	Jessa Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Middelheim Ziekenhuis		Antwerp			Belgium
UZ Brussel