The main objective of phase I of this study is to collect data which will be used to develop and train a frailty classification algorithm.Primary objective: The main objective is to determine the agreement of the frailty classification between the…
ID
Source
Brief title
Condition
- Heart failures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Frailty algorithm of Corsano Cardiowatch epoch agreement with corresponding G8
measured in overall accuracy and weighted kappa between Frailty algorithm of
Corsano Cardiowatch and the golden standard G8 questionnaire (frail or
non-frail) and the FRAIL score (frail, pre-frail and non-frail).
Secondary outcome
Frailty algorithm of Corsano Cardiowatch epoch agreement with 6MWT measured in
overall accuracy, sensitivity and specificity.
Background summary
Wrist wearables have the potential to continuously and accurately classify
frailty. The Corsano CardioWatch 287-2 is such a medical device with that
potential. The collection of clinical data in phase I of this study is required
to develop and train a frailty algorithm for the Corsano CardioWatch 287-2.
Study objective
The main objective of phase I of this study is to collect data which will be
used to develop and train a frailty classification algorithm.
Primary objective: The main objective is to determine the agreement of the
frailty classification between the Corsano CardioWatch and the gold standard
Geriatric 8 (G8) questionnaire, and the FRAIL scale.
Secondary objective: To determine the accuracy of frailty classification
between the Corsano CardioWatch and the 6-minute walk test (6MWT). In addition,
the 6MWT data will be used to further validate the Corsano gait algorithm.
Study design
These patients will be asked to undergo a G8 assessment, FRAIL scale
assessment, 6MWT and wear the Corsano CardioWatch 287-2 for 6 days, 3 days
approximately 2 weeks before the procedure and 3 days approximately 2 months
after the procedure. In the first set of patients (n=20) this data will be used
to train a classification algorithm for the Corsano CardioWatch 287-2 (stage
I). In a second set of patients (n=20), this data will be used to validate the
new classification algorithm of the Corsano CardioWatch 287-2 (stage II). The
current protocol focuses only on phase I. Later on, phase II will be
researched.
Study burden and risks
The study involves conducting two G8 questionnaires, two FRAIL scale
assessments, two 6MWT and wearing the Corsano CardioWatch 287-2 for 6 days in
total. Therefore, the study burden and risks are minimal. However, after
development of the Corsano CardioWatch 287-2 frailty classification algorithm,
the device has the potential to allow continuous and remote frailty monitoring.
Wilhelmina van Pruisenweg 35
Den Haag 2595 AN
NL
Wilhelmina van Pruisenweg 35
Den Haag 2595 AN
NL
Listed location countries
Age
Inclusion criteria
* >= 70 years old
* Able to provide consent
* Be scheduled to undergo on of the following procedures:
** Aortic valve replacement
** Mitral valve repair with MitraClip
** Implantation of a pacemaker
** Percutaneous coronary intervention (PCI)
Exclusion criteria
* 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)
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| CCMO | NL86687.058.24 |