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

Azienda Ospedaliera Città della Salute e della Scienza di Torino

Status: Unknown

Conditions: Accidental Falls; Wearable Electronic Devices

Treatments: Device: Wearable watch device

Study type: Interventional

Funder types: Other

Identifiers

NCT04398615

ADAMO

Details and patient eligibility

About

"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.

Enrollment: 100 estimated patients

Sex: All

Ages: 75+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Aged 75 years and older
• At least 2 fall events during the 12 months previous to enrollment
• Signed written informed consent

Exclusion criteria

• Severe cognitive impairment
• Bedridden condition
• Patients unable to walk autonomously (walking aids allowed)

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Intervention

Experimental group

Description:

Single arm, receiving the experimental device

Treatment:

Device: Wearable watch device