The value of ICT guided disease management combined with telemonitoring for heart failure patients.

Conditions: Heart failure, disease management systems, ICT guided protocols, telemonitoring, telemedicine, telecare, cost effectiveness

Registration Number: NL-OMON20035

Lead Sponsor: niversity Medical Center Groningen (UMCG), department of cardiology

Brief Summary: /A

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 450

Inclusion Criteria

Patients are eligible when they are admitted to the IC/CCU or cardiology ward for heart failure, NYHA class III-IV, have evidence for structural underlying heart disease, are intravenously treated with diuretics during their hospitalisation, have a documented ejection fraction less or equal than 40% in the previous 3 months, are at least 18 years old, male or female and are able to understand content of and willing to provide informed consent.

Exclusion Criteria

Patients will be excluded from the study when they have a history of myocardial infarction in the previous 1 month, have a life expectation less then 1 year, have a history of valve replacement or surgery within the previous 6 months, have undergone cardiac invasive intervention within the last 6 months or planned to have such a procedure in the following 3 months, are evaluated for heart transplantation prior or during the study, are inable to fill out questionnaires, are inable to use telemedicine devices at home or participate at another clinical intervention trial.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. A composite end point for death;<br /><br>2. Readmission for heartfailure;<br /><br>3. Change in quality of life.

Secondary Outcome Measures

Name	Time	Method
1. Death from any cause;<br /><br>2. First readmission for heart failure;<br /><br>3. Change in quality of life;<br /><br>4. Treatment according to guidelines;<br /><br>5. Optimal dosage of medication;<br /><br>6. Number of visits to the heart failure clinic;<br /><br>7. HF knowledge and self-care behaviour;<br /><br>8. Cost-benefit ratio.