FRAILTY Classification Algorithm for the Corsano CARDIOWATCH 287-2: a Development and Validation Study
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age70+
SponsorCorsano Health B.V.
About this trial
The FRAILTY-CARDIOWATCH study is investigating how well the Corsano CardioWatch 287-2, a wrist-worn medical device, can classify frailty in patients. Frailty is a condition often seen in older adults, characterized by decreased strength, endurance, and overall health, which can make individuals more vulnerable to illness or injury. The goal of this study is to develop an algorithm that can accurately assess frailty using the device. In phase 1 of the study, data will be collected from patients aged 70 or older who are scheduled for heart-related procedures, such as valve replacements or pacemaker implantation.
The study aims to compare the frailty classifications of the CardioWatch with two established methods: the Geriatric 8 (G8) questionnaire and the FRAIL scale. It will also compare the CardioWatch with the 6-minute walk test. Patients will wear the CardioWatch for six days-three days before their procedure and three days after-and complete the G8, FRAIL, and 6-minute walk tests. The collected data will help develop and train the frailty classification algorithm.
The main focus is to evaluate how well the frailty classifications from the CardioWatch match those from the other tests. This research could potentially lead to a more accurate and continuous way to monitor frailty in patients using wearable technology.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥ 70 years old
Be able to provide consent
Aortic valve replacement
Mitral valve repair with MitraClip
Disqualifiers
Unable to wear the Corsano CardioWatch 287-2 due to reasons such as allergic reactions, wounds, amputations etc.;
Unable or unwilling to sign informed consent;
Significant mental or cognitive impairment;
Cardiovascular disease where heart rate is not measurable (e.g. LVAD)
Trial population
Patients ≥ 70 years of age who are scheduled to undergo aortic valve replacement, mitral valve repair with MitraClip, implantation of a pacemaker or percutaneous coronary intervention (PCI) at the Reinier de Graaf Gasthuis Cardiology department.
Trial design
Design model
Case-crossover
Time perspective
Prospective
Treatments tested in this trial
Corsano CardioWatch 287-2
DeviceEligible patients are asked to wear the Corsano CardioWatch 287-2 for 6 days, of which 3 days approximately 2 weeks before the procedure and 3 days approximately 2 months after the procedure.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Patients undergoing cardiac surgical intervention1 intervention
Trial outcomes
Primary outcomes
1
Frailty score agreement between Geriatric-8 questionnaire and CardioWatch 287-2
G8 questionnaire: when a G8 score ≤ 14 is obtained the patient is considered as frail. When a G8 score \> 14 is obtained the patient is considered as non-frail The following parameters will be calculated: * Accuracy: the proportion of correctly classified frailty stages compared to the total number of frailty stages. This accuracy will be calculated for every participant separately and will thereafter be averaged over all patients. o Accuracy: (TP + TN) / (TP + TN + FP + FN) * For comparing the G8 score outcomes and the CardioWatch frailty scores the (frail vs. non-frail) the following parameters will be calculated: * Specificity: TN / (TN + FP) * Sensitivity: TP / (TP + FN)
Time frame
From start to end of first CardioWatch 287-2 measurement (~2 week prior to surgery) and from start to end of second CardioWatch 287-2 measurement ('~2 months after surgery)2
Frailty score agreement between FRAIL questionnaire and CardioWatch 287-2
FRAIL score: when a FRAIL score ≥ 3 is obtained the patient is considered as frail. When a FRAIL score of 1-2 is obtained the patient is considered as pre-frail, and when a FRAIL score of 0 is obtained the patient is considered as non-frail. The following parameters will be calculated: * Accuracy: the proportion of correctly classified frailty stages compared to the total number of frailty stages. This accuracy will be calculated for every participant separately and will thereafter be averaged over all patients. o Accuracy: (TP + TN) / (TP + TN + FP + FN) * For comparing the FRAIL score outcomes and the CardioWatch frailty scores (frail, pre-frail and non-frail) the following parameters will be calculated for every outcome possibility (CardioWatch: frail; pre-frail; non-frail) and participant separately and will thereafter be averaged per outcome possibility over all patients: * Specificity: TN / (TN + FP) * Sensitivity: TP / (TP + FN)
Time frame
From start to end of first CardioWatch 287-2 measurement (~2 week prior to surgery) and from start to end of second CardioWatch 287-2 measurement ('~2 months after surgery)Secondary outcomes
1
Frailty score agreement between 6-minute walking test and CardioWatch 287-2
Participants will be categorized based on the 6MWT. If the 6MWT is less than 300 meters, the participant is categorized as low endurance (LE). If the 6MWT is greater than 300 meters, the participant is classified as normal endurance (NE). The 300 meter cut off point ismchosen because it is widely used in literature. The following parameters will be calculated for every participant separately and will thereafter be averaged over all patients:. * Accuracy: (TP + TN) / (TP + TN + FP + FN) * Specificity: TN / (TN + FP) * Sensitivity: TP / (TP + FN)
Time frame
From start to end of first CardioWatch 287-2 measurement (~2 week prior to surgery) and from start to end of second CardioWatch 287-2 measurement ('~2 months after surgery)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: