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

The value of innovative ICT guided disease management combined with telemonitoring in outpatient clinics for chronic heart failure patients.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON20035
Enrollment
450
Registered
2009-07-07
Start date
2009-09-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

1. ICT guided disease management without telemedicine. Patients will receive care with an ICT guided disease management system (CardioConsult). The patient will also recieve tailored information on li
2. ICT guided disease management with telemedicine. The above described disease management system will function together with telemedicine devices (weightscale, ECG, healthmonitor and blood pressure m

Sponsors

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

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
1. A composite end point for death; 2. Readmission for heartfailure; 3. Change in quality of life.

Secondary

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

Contacts

Public ContactA.E. Vries, de

Department of Cardiology University Medical Center Groningen

a.e.de.vries@umcg.nl+31 50 3612094

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)