Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05885425 |
| Other study ID # |
OPII-VA/DP/2021/9.3-01 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2023 |
| Est. completion date |
September 1, 2024 |
Study information
| Verified date |
May 2023 |
| Source |
Trnava University in Trnava |
| Contact |
Silvia Putekova |
| Phone |
+421908835994 |
| Email |
silvia.putekova[@]truni.sk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
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.
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)
