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

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

"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.

Study Overview

• Status: Unknown
• Conditions: Accidental Falls; Wearable Electronic Devices
• Intervention / Treatment: Device: Wearable watch device

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • TO
    • Torino, TO, Italy, 10126
      • S.C. Geriatria e Malattie Metaboliche dell'Osso U, A.O.U. Città della Salute e della Scienza di Torino

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intervention; Single arm, receiving the experimental device

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.; Other Names: ADAMO

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera Città della Salute e della Scienza di Torino
• Collaborators: Consoft Sistemi S.p.A. Turin, Italy; Caretek S.r.l. Turin, Italy
• Investigators: Principal Investigator: Renata Marinello, MD, PhD, OAU Città della Salute e della Scienza di Torino, Turin, Italy

Publications and helpful links

General Publications

• Kempen GI, Yardley L, van Haastregt JC, Zijlstra GA, Beyer N, Hauer K, Todd C. The Short FES-I: a shortened version of the falls efficacy scale-international to assess fear of falling. Age Ageing. 2008 Jan;37(1):45-50. doi: 10.1093/ageing/afm157. Epub 2007 Nov 20.
• Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. doi: 10.1111/j.1532-5415.1991.tb01616.x.
• Scheffer AC, Schuurmans MJ, van Dijk N, van der Hooft T, de Rooij SE. Fear of falling: measurement strategy, prevalence, risk factors and consequences among older persons. Age Ageing. 2008 Jan;37(1):19-24. doi: 10.1093/ageing/afm169.
• Ganz DA, Higashi T, Rubenstein LZ. Monitoring falls in cohort studies of community-dwelling older people: effect of the recall interval. J Am Geriatr Soc. 2005 Dec;53(12):2190-4. doi: 10.1111/j.1532-5415.2005.00509.x.

Helpful Links

• EuroQol EQ-5D

Study record dates

Study Major Dates

• Study Start (Anticipated): May 25, 2020
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: May 15, 2020
• First Submitted That Met QC Criteria: May 20, 2020
• First Posted (Actual): May 21, 2020

Study Record Updates

• Last Update Posted (Actual): May 21, 2020
• Last Update Submitted That Met QC Criteria: May 20, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Aged; Wearable Electronic Devices; Telemetry; Fall detection
• Other Study ID Numbers: ADAMO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No