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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON33608
Enrollment
450
Registered
2009-03-23
Start date
2010-01-14
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

Chronic Heart Failure

Interventions

Two types of interventions will be compared to a control group. - Patients in the control group (n=225) will receive care as usual . - Patients in intervention group 1 (n=150) will receive care drive

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: •Patients are diagnosed with systolic heart failure (NYHA III- IV) •Evidence for structural underlying heart disease •Patients are intravenously treated with diuretics during their hospitalisation •Documented Ejection Fraction = 18 years •Patients have to be able to understand content of and willing to provide informed consent

Exclusion criteria

Exclusion criteria: •Patients

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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 contr

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)