Heart Failure Hypertensive diseases
Conditions
Interventions
This is an open-label, non-randomized study without masking, consisting of two groups, G1 and G2, with 12 participants in each group. Participants will receive continuous remote monitoring of vital si
Sponsors
Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Eligibility
Inclusion criteria
Inclusion criteria: Older adults with moderate to severe frailty (Fried et al., 2001) and/or impaired mobility will be included in the study; including bedridden or wheelchair-bound patients; patients or their caregivers who have the cognitive and motor ability to use the telemonitoring platform and application, or who may be trained to do so; participants must present relevant chronic conditions; such as heart failure or hypertension; it is important that patients have stable internet access in their homes or in the locations where the devices will be used, through Wi-Fi or mobile data connections.
Exclusion criteria
Exclusion criteria: Participants already using any other type of telemonitoring device will be excluded from the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A reduction in the frequency of healthcare service utilization among frail older adults undergoing continuous telemonitoring is expected, verified through comparison of the number of emergency department visits, unscheduled medical visits, and hospitalizations before and after the intervention, considering a minimum reduction of 20% in these events throughout the follow-up period. | — |
Secondary
| Measure | Time frame |
|---|---|
| An increase in the implementation of early therapeutic adjustments in patients undergoing continuous telemonitoring is expected, verified through clinical records of interventions performed by the healthcare team, considering a minimum increase of 15% in the frequency of therapeutic adjustments compared with the pre-intervention period;An improvement in chronic disease management, overall clinical condition, and participants’ well-being is expected, verified through the analysis of clinical parameters, monitored vital signs, and validated quality of life and health assessment instruments, considering a minimum improvement of 10% in the evaluated indicators after the intervention;The usability, acceptability, and adherence to the wearable device and mobile application by participants and/or caregivers are expected to be evaluated, verified through standardized user experience questionnaires and platform usage rates, considering a minimum adherence rate of 80% to continuous use of the technology during the study;Technical and operational difficulties related to the use of telemonitoring technology are expected to be identified, verified through technical support records, participant reports, and the frequency of operational failures, considering the occurrence and categorization of the main issues identified throughout the follow-up period;The accuracy and reliability of the measurements obtained by the wearable device under real-world conditions are expected to be validated, verified through comparison between data obtained from the device and reference equipment used in clinical practice, considering a minimum agreement rate of 90% between the measurements performed | — |
Countries
BR
Contacts
Public ContactCarlos Carvalho
Instituto do Coração, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
Outcome results
None listed