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

NCT04398615 | Unknown

• 1 other identifier: ADAMO
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Aged; Telemetry; Wearable Electronic Devices; Fall detection

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Variation in quality of life reported at three levels EQ-5D (EQ-5D-5L) Questionnaire

  At enrollment and at 6 months

• Variation in fear of falling evaluated with Short Falls Efficacy Scale International (Short FES-I)

  At enrollment and at 6 months

Study Arms (1)

Intervention

EXPERIMENTAL

Single arm, receiving the experimental device

Device: Wearable watch device

Interventions

Wearable watch device 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.

Also known as: ADAMO

Intervention

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• A.O.U. Città della Salute e della Scienza: lead
• Caretek S.r.l. Turin, Italy: collaborator
• Consoft Sistemi S.p.A. Turin, Italy: collaborator

Study Sites (1)

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

Torino, TO, 10126, Italy

Location

Related Publications (4)

• 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.

  PMID: 18194967 BACKGROUND

• 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.

  PMID: 18032400 BACKGROUND

• 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.

  PMID: 1991946 BACKGROUND

• 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.

  PMID: 16398908 BACKGROUND

Related Links

• EuroQol EQ-5D

Study Officials

• Renata Marinello, MD, PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Renata Marinello, MD, PhD

CONTACT

0116334771; rmarinello@cittadellasalute.to.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: During the follow-up period both healthcare personnel and investigators will not be aware of data (including fall events) registered by the experimental device.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 15, 2020
• First Posted: May 21, 2020
• Study Start: May 25, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: May 21, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)