Clinical trial NCT04398615: Validation of the ADAMO Watch for the Early Detection of Fall Events in Older Patients
Official title: Validazione Dell'Orologio ADAMO Per l'Individuazione Precoce Delle Cadute Nel Paziente Anziano
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Accidental Falls
Wearable Electronic Devices
Keywords: Aged
Telemetry
Wearable Electronic Devices
Fall detection
Lead sponsor: A.O.U. Città della Salute e della Scienza
Sponsor class: OTHER
Collaborators: name: Caretek S.r.l. Turin, Italy
name: Consoft Sistemi S.p.A. Turin, Italy
First posted: 2020-05-21
Enrollment: 100
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Incidence of self-reported fall events
timeFrame: 6 months
measure: Incidence of device-reported fall events
timeFrame: 6 months
Secondary outcomes:
measure: Variation in quality of life reported at three levels EQ-5D (EQ-5D-5L) Questionnaire
timeFrame: At enrollment and at 6 months
measure: Variation in fear of falling evaluated with Short Falls Efficacy Scale International (Short FES-I)
timeFrame: At enrollment and at 6 months
Other outcomes:
Locations:
city: Torino
country: Italy
facility: S.C. Geriatria e Malattie Metaboliche dell'Osso U, A.O.U. Città della Salute e della Scienza di Torino
state: TO
Study officials:
affiliation: OAU Città della Salute e della Scienza di Torino, Turin, Italy
name: Renata Marinello, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.