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

Study Overview
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Brief Summary
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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.

Official Title
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Validazione Dell'Orologio ADAMO Per l'Individuazione Precoce Delle Cadute Nel Paziente Anziano

Conditions
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Accidental Falls, Wearable Electronic Devices

Intervention / Treatment
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* Device: Wearable watch device


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Single arm, receiving the experimental device | Device: Wearable watch device<br>* 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.<br>* Other names: ADAMO;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of self-reported fall events | Fall event incidence evaluated through scheduled phone call interviews with the patient or the caregiver, from enrollment every 15 days through to 6 months, recording also timing and context of event, environmental factors, health status at the moment of the event, health consequences, therapeutic modifications. | 6 months | 
| Incidence of device-reported fall events | Fall event incidence automatically evaluated by the wearable watch device, based on biometric data continuously recorded from enrollment through to 6 months. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation in quality of life reported at three levels EQ-5D (EQ-5D-5L) Questionnaire | Patient's quality of life will be evaluated both at enrollment and at 6 months through the five levels EQ-5D (EQ-5D-3L) Questionnaire, exploring the five dimensions of mobility, self-care, usual activities, pain/discomfort and anxiety depression (each dimension scored 1-3, with 3 indicating worse problems), and a general measure of perceived health on a Visual Analogue Scale (EQ-VAS), scored 0-100 (with 100 indicating the best perceived health possible) | At enrollment and at 6 months | 
| Variation in fear of falling evaluated with Short Falls Efficacy Scale International (Short FES-I) | Patient's fear of falling be evaluated both at enrollment and at 6 months through the Short Falls Efficacy Scale International (Short FES-I) Status (minimum 7-maximum 28, higher levels indicating most severe concern about falling) | At enrollment and at 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Telemetry, Aged, Wearable Electronic Devices, Fall detection