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Validation of the ADAMO Watch for the Early Detection of Fall Events in Older Patients

NCT04398615 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2020-05-21

No results posted yet for this study

Summary

"La Casa nel Parco" (CANP) Project is a multidisciplinary project funded by the European Union and Regione Piemonte aimed to explore innovative technology application in the care of older subjects. In this context, ADAMO is a single arm open label trial evaluating the capability of a wearable watch device to correctly detect fall events in community-dwelling older subjects aged 75 years and older, at high risk of falls. Secondary objectives of the study are to identify specific patterns on telemetric measures and health status variations able to predict future fall events, and to evaluate the tolerability and the influence on patient's quality of life of this wearable device.

The main objectives of the study are to evaluate the impact of the intervention on 1) medication adherence after discharge 2) medication appropriateness.

Conditions

  • Accidental Falls
  • Wearable Electronic Devices

Interventions

DEVICE

Wearable watch device

Every study participant will be given a wearable watch device at the beginning of the study and will be instructed on how to use the device and to wear it continuously throughout the duration of the study (6 months total follow-up). The device will register biometric data and automatically archived. During the follow-up period both healthcare personnel and investigators will not be aware of data (including fall events) registered by the experimental device.

Sponsors & Collaborators

  • Caretek S.r.l. Turin, Italy

    collaborator UNKNOWN

  • Consoft Sistemi S.p.A. Turin, Italy

    collaborator UNKNOWN

  • A.O.U. Città della Salute e della Scienza

    lead OTHER

Principal Investigators

  • Renata Marinello, MD, PhD · OAU Città della Salute e della Scienza di Torino, Turin, Italy

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-05-25
Primary Completion
2020-12-31
Completion
2020-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04398615 on ClinicalTrials.gov