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

NCT ID: NCT04398615

Last Updated: 2020-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-25

Study Completion Date

2020-12-31

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.

Detailed Description

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Conditions

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Accidental Falls Wearable Electronic Devices

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

During the follow-up period both healthcare personnel and investigators will not be aware of data (including fall events) registered by the experimental device.

Study Groups

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Intervention

Single arm, receiving the experimental device

Group Type EXPERIMENTAL

Wearable watch device

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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ADAMO

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)
Minimum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Caretek S.r.l. Turin, Italy

UNKNOWN

Sponsor Role collaborator

Consoft Sistemi S.p.A. Turin, Italy

UNKNOWN

Sponsor Role collaborator

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

OTHER

Sponsor Role lead

Responsible Party

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Dott.ssa RENATA MARINELLO

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Renata Marinello, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

OAU Città della Salute e della Scienza di Torino, Turin, Italy

Locations

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

Torino, TO, Italy

Site Status

Countries

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Italy

Central Contacts

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Renata Marinello, MD, PhD

Role: CONTACT

0116334771 ext. +39

Facility Contacts

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Renata Marinello, MD, PhD

Role: primary

0116334771 ext. +39

References

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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.

Reference Type BACKGROUND
PMID: 18194967 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18032400 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 1991946 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16398908 (View on PubMed)

Related Links

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Other Identifiers

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ADAMO

Identifier Type: -

Identifier Source: org_study_id

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