1H2C4: One Heart to Care for

Sponsor

Hasselt University (Other)

Overall Status

Withdrawn

CT.gov ID

NCT04753398

Collaborator

Ziekenhuis Oost-Limburg (Other), WGK Limburg (Other)

Enrollment

Location

Arms

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Heart Failure	Device: Blood Pressure Monitor, medication dispenser, telemonitoring technology	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Supportive Care

Official Title:

One Heart to Care for, Your Heart to Take Care of.

Actual Study Start Date :

Jan 1, 2014

Actual Primary Completion Date :

Dec 1, 2015

Actual Study Completion Date :

Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Telemonitoring group Additional telemonitoring devices: Blood Pressure Monitor, medication dispenser, telemonitoring technology	Device: Blood 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. Other Names: Telemedicine remote monitoring remote follow-up
No Intervention: Control group usual care, without telemonitoring

Arm

Intervention/Treatment

Experimental: Telemonitoring group

Additional telemonitoring devices: Blood Pressure Monitor, medication dispenser, telemonitoring technology

Device: Blood 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.

Other Names:

Telemedicine

remote monitoring

remote follow-up

No Intervention: Control group

usual care, without telemonitoring

Outcome Measures

Primary Outcome Measures

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.
Mean medication doses [week 24]
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 6 months

Secondary Outcome Measures

Medication titration [up to one year]
Mean doses ACE-I/angiotensin receptor blockers (ARB) en BB after 6 months
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)
Number of (telephone) contacts, registered by the heart failure nurse [Up to one year]
Number of (telephone) contacts, registered by the heart failure nurse
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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