Heart Failure
Conditions
Keywords
Heart Failure, Telemonitoring, medication up titration, automatic blood pressure device, medication dispenser
Brief summary
This is an open randomized clinical trial with two study arms. One group, receiving usual care for heart failure, will be compared to another group, receiving usual care plus active telemonitoring interference. When leaving the hospital, the usual care arm receives a document with a predefined medication scheme and advice for the general practitioner (like it is currently done in usual care). Besides the normal consultations at 2 and 5 weeks, no active interactions take place between the study nurse and the patient. The telemonitoring interference in the other study arm consists of an automatic blood pressure device and medication dispenser that transmit data to a central platform. During the first 12 weeks, the nurse of the call center will give incentive for medication up titration on the basis of the available data. Before up titration can be done, the patient needs to take blood pressure measurements 3 times in the morning and 3 times in the evening and at least 6 measurements a week.
Interventions
DEVICEBlood Pressure Monitor, medication dispenser, telemonitoring technology
The telemonitoring interference in the telemonitoring arm consists of an automatic blood pressure device and medication dispenser that transmit data to a central platform.
Sponsors
Ziekenhuis Oost-Limburg
WGK Limburg
Hasselt University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* \- Age ≥ 50 * Patient has to be followed in Ziekenhuis Oost-Limburg or Jessa Ziekenhuis Hasselt * The patient has to be able to live independently or in a service flat * The diagnosis of heart failure or severe myocardial infarction has to be done after September 1, 2013 according to: * Left ventricular ejection fraction (LVEF) \<40% * eGFR\>30ml/min/kg * Treatment minimally with ACE-I and BB * The general practitioner had to give his approval for the installation of telemonitoring On the basis of an interview between the heart failure nurse and patient, one will decide if the patient is eligibil to join the study. The patient also needs to speak sufficient Dutch to be communicative about his/her medical condition.
Exclusion criteria
* Reversible form of heart failure * Heart failure due to severe aortic stenosis * eGFR less than 30ml/min/kg * Presence of a cardiac resynchronization therapy (CRT) device * Palliative status following the RIZIV guidelines or according to the assessment of the cardiologist (\<1 year) * Patients staying in a nursing or retirement home * Active treatment with either ACE-I/ARB or BB
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean medication doses | week 12 | Define whether the mean medication doses of angiotensin-converting-enzyme inhibitor (ACE-I) and bètablockers (BB) in the group with telemonitoring is higher than in the group with usual care (without telemonitoring) after 12 weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality | Up to one year | All-cause mortality |
| All cardio-related hospitalisations (number and time) | Up to one year | * Arrythmogenic nature * Ischemic nature * Heart failure nature * Valvular/surgical nature * Elektrofysiological nature (implantation ICD, CRT,…) |
| All heart failure hospitalisations | Up to one year | * Treatment with (whether or not intravenous) diuretic therapy * Treatment with hemodynamic guided therapy (vasodilators) * Treatment with intravenous inotropics |
| Number of medical practitioner-patient contacts | Up to one year | * In hospital (medical record) * At patient home (WGK) |
| Medication titration | up to one year | Mean doses ACE-I/angiotensin receptor blockers (ARB) en BB after 6 months |
| Number of (telephone) contacts for the encouragement of medication compliance | Up to one year | Number of (telephone) contacts for the encouragement of medication compliance |
| Evolution of heart failure and comorbidities | up to one year | * Blood collection with: kidney function determinations, electrolytes, heart markers (NT-proBNP) * Echo parameters (cardiac output, LVEF, diameters end systolic and diastolic) * Exercise stress tests (VO2max, maximal wattage, maximal heart rate) * Weight, length, blood pressure, ECG |
| Quality of life according to the HeartQoL questionnaire | day 1, month 12 | — |
| Satisfaction survey | month 12 | Satisfaction survey about the received care (anonymous) |
| Number of (telephone) contacts, registered by the heart failure nurse | Up to one year | Number of (telephone) contacts, registered by the heart failure nurse |
Countries
Belgium
Outcome results
None listed