The value of INnovative ICT guided Disease Management combined with Telemonitoring in OUt patient clinics for Chronic Heart failure patients

Primary endpoint of the study is a composite score made up of weighted values

for;

•Death from any cause;

•First readmission for heart failure, defined as an overnight stay in a

hospital (with different dates for admission and discharge) for progression of

heart failure or directly related to heart failure;

•Change in quality of life at end of study compared to baseline, assessed by

the Minnesota Living with Heart Failure Questionnaire.

Secondary endpoints of the study are the separate components of the first

primary endpoint;

•Death from any cause.

•First readmission for heart failure, defined as an overnight stay in a

hospital (with different dates for admission and discharge) for progression of

heart failure or directly related to heart failure.

•Change in Quality of life at end of study compared to baseline measured with

the Minnesota Living with Heart Failure Questionnaire.



In addition, data will be collected on the following secondary endpoints:



•The number of days a patient was alive and out of the hospital after discharge.

•Total number and duration of hospital admissions related to heart failure.

•Total number and duration of all hospital admissions.

•Treatment according to guidelines using the criteria of the Guidelines

Adherence Indicator-3 and 9 months after discharge. This instrument assesses 4

relevant groups of medication, dependent of New York Heart Association (NYHA)

functional class; ACE-Inhibitors (ACE-I) or angiotensine receptor blockers

(ARB), beta blockers (BB) and aldosteronantagonists (AA). Two aspects of

Guideline Adherence will be evaluated;

- Is the patient on the type of medication described according to ESC

guidelines

- Is the patient on optimal dose of medication according to ESC Guidelines.

Actual daily doses for every medication from the drug classes ACE-I, ARB , BB

and AA will be calculated in percent of daily target doses. Data will be

adjusted for relative contraindications (COPD, bradycardia, symptomatic

hypotension, renal dysfunction, hyperkalemia)

•The number of days necessary to establish optimal medication treatment, e.g.

optimal dose of ACE-I or ARB, BB and AA, calculated from the day of discharge

until the day a patient is on optimal medication. The maximum dose of

medication which is tolerated by the patient.

•In both intervention groups, the moment optimal medication is reached will be

assessed by ICT guided DMS. In the control hospitals, this moment will be

assessed by the supervising cardiologist of the HF clinic.

•Number of days from discharge of the index hospitalisation until the moment

that a patient is on optimal heart failure medication (ACE-I, ARB, BB and AA).

The moment of optimal heart failure medication is defined as the moment that

the patient endures the maximum dose of heart failure medication (ACE-I, ARB,

BB and AA) which is prescribed according to latest ESC guidelines on acute and

chronic heart failure.

•Number of visits to the outpatient HF clinic.

•Number of visits to the emergency department.

•Patient and carer satisfaction at end of study compared with baseline.

•HF knowledge and self-care behavioural end of study compared with baseline.

•Patients sense of control at end of study compared with baseline.

•Cost-benefit ratio