Management of Telemedicine Monitoring of Patients With Chronic Heart Failure

TELEHEART-Management of Telemedicine Monitoring of Patients With Chronic Heart Failure

Objective: to evaluate the possibilities and effect of telemedicine monitoring and management of patients with CHF (compared to patients with CHF without intensive telemedicine monitoring) on quality of life, prognosis and the presence of complications and hospitalisations.

Patients with a stable form of congestive heart failure will be gradually included in the study. Half of them will be defined by random selection to intervention group. Parameters, that can be measured at home will be periodically telemedical monitored. In according with at home monitored data, the own physician will be able to intervene with change of medical treatment in the case of non-physiological deviations in order to improve the health status as well as the prognosis of the patient with CHF.

Study Overview

• Status: Not yet recruiting
• Conditions: Congestive Heart Failure Chronic
• Intervention / Treatment: Behavioral: Telemedicine correction of medical treatment; Behavioral: Education for proper lifestyle

Detailed Description

Inclusion criteria:

• Age between 45 and 75
• Congestive heart failure (CHF), NYHA II - VI (any genesis)
• EF less then 45%, any rhythm (sinus or atrial fibrillation)
• More as two months stable condition
• Complete treatment according to recommendations (guidelines): ACEI (alternatively ARNI / sartan) + diuretics + betablockers (as alternative digitalis)
• Without hospitalization with CHF decompensation more as two months before enrolment
• No severe liver disease and hemodialysis treatment
• No planned any cardio-surgery intervention in the next six months
• No a serious valvular defects

Input and output surveys (measurements, tests) upon enrollment and after half a year ECHOCG (mandatory parameters: EF, LVDd, IVCT, E/A, LA diameter, LA area planimetrically) Blod pressure, frequency, ECG (PQ, QT, description: blockages, STT segment changes) Six minutes walking test Serum analysis: NTproBNP, CRP, natrium, potassium, urea, creatinine

Questionnaires:

• Kansas Quality of Life Questionnaire (KCCQ)
• Questionnaire SF 36 (perception of illness)
• Beck's Depression Inventory (21 questions) - depression questionnaire
• Beck's Anxiety Inventory (21 questions) - anxiety questionnaire (standardized questionnaires translated into Slovak)

Telemedicine monitoring: the patient will have at home devices for:

ECG recording Blood pressure and pulse sensor O2 saturation sensor Personal weight machine

Data will be transferred via smartphone software (supplied by the organizer) once a week too physician:

ECG recording on the patient's instructions

1. st morning in bed after waking up (stick electrodes for whole day)
2. nd. after breakfast (or an hour after getting out of bed)
3. th. around 12 o'clock (time of lunch)

In the same day morning, weight and other measurements (O2, blood pressure, pulse)

As part of the data transfer, the information for physician:

possibility to send a comment "how I feel" the number of urinations per night Data is entered into a standard table in the doctor's software (supplied by the organizer) Based on the obtained data, the doctor can correct the treatment at any time by telephone

Physician will control the transferred data from patient at least once every week.

The organizer will deliver Personal weight machine (new uniform) Questionnaires (in printed form) Informed consents devices for monitoring of physiological functions (ECG, O2, pulse, blood pressure) Application for the patient's smartphone (for simple data transfer) Software recording data from the patient to the PC at the physician's office Compensation 100,- € (motivation for each participant - intervened or non-intervened) similar compensation is assumed at the end of follow-up (for each patient) The ECG sensor will remain available to the physicians Included doctors will be co-authors of publications in foreign journals.

Monitored events ("end points"):

hospitalization for cardiac causes visit to the emergency room (urgent) calling Quick Medical Assistance at home unplanned visit by cardiologist / internist fundamental change of treatment (new type of drug, change of drug group, increased dose) fundamental changes (deterioration) in the perception of the disease (SF 36) major changes in quality of life (Kansas Questionnaire) fundamental changes in the perception of depression (Beck's Depression Inventory) fundamental changes in the perception of anxiety (Beck's Anxiety Inventory) Death

Evaluation in addition to endpoints:

long-term trend of resting frequency long-term trend of increased frequency after morning exercise and during the day long-term blood pressure and saturation trends number of telephone contacts by physicians with the patient in the case of using a "smart watch", also trends in sleep parameters (frequency, apnea, sleep quality, caloric expenditure / day)

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Silvia Putekova; Phone Number: +421908835994; Email: silvia.putekova@truni.sk
• Study Contact Backup: Name: Zuzana Kralova; Phone Number: +421917868088; Email: zuzana.kralova@truni.sk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with congestive heart failure with ejection fraction less than 45%

Description

Inclusion Criteria:

• Congestive heart failure (CHF), NYHA II - VI (any genesis)
• EF less then 45%, any rhythm (sinus or atrial fibrillation)
• More as two months stable condition
• Complete treatment according to recommendations (guidelines): ACEI (alternatively ARNI / sartan) + diuretics + betablockers (as alternative digitalis)
• Without hospitalization with CHF decompensation more as two months before enrolment

Exclusion Criteria:

• malignant diseases
• planned cardiac surgery

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
100 patients with stabile chronic heart failure with remote control; Group 1 is the intervention group, their health status will be monitored telemetrically for a half year by several electronic devices (for measurement of hearth frequency, blood pressure, blood saturation and periodically ECG recordings). Data will be periodically transmitted to the doctor in the ambulance. If measured data will indicated any worsening of heath (decompensation of circulation), physician will adjust the treatment remotely.	Behavioral: Telemedicine correction of medical treatment; On the basis of telemedicine data, the doctor will remotely correct medical treatment by adjusting the dose or supplementing or by omitting the medicine in order to improve the state of health, or to alleviate the symptoms of the disease monitored by telemedicine; Behavioral: Education for proper lifestyle; Based on telemedicine data, the doctor can consider periodic education of the patient with the innervated group in order to improve lifestyle
Non-intervention group: 100 patients with stabile chronic heart failure without remote control; Group 2 with patients with chronic heart failure in the non-intervention group, they will not be contacted by own physician for half a year - the planned periodic control will be scheduled after half a year.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Hospitalization for cardiac reasons	6 months
Visit to the emergency room (urgent)	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Unplanned visit to cardiology / internist	6 months
Calling Quick Medical Assistance home	6 months
Fundamental change of treatment (new type of drug, change of drug group, increased dose)	6 months
Fundamental changes in the quality of life according to questionnaires	6 months

Collaborators and Investigators

• Sponsor: Trnava University in Trnava
• Investigators: Principal Investigator: Eva Goncalvesova, National Institute of Vascular and Heart Diseases Bratislava; Study Chair: Fedor Lehocki, Slovak University of Technology in Bratislava; Study Director: Jozef Benacka, Trnava University in Trnava

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2023
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: May 22, 2023
• First Submitted That Met QC Criteria: May 22, 2023
• First Posted (Estimated): June 2, 2023

Study Record Updates

• Last Update Posted (Estimated): June 2, 2023
• Last Update Submitted That Met QC Criteria: May 22, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Congestive Heart Failure, Telemedicine
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: OPII-VA/DP/2021/9.3-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No