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

Accidental Falls Clinical Trial

— ADAMO  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04398615
• Other study ID #: ADAMO
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 25, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: May 2020
• Source: Azienda Ospedaliera Città della Salute e della Scienza di Torino
• Contact: Renata Marinello, MD, PhD
• Phone: 0116334771
• Email: rmarinello[@]cittadellasalute.to.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 75 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Accidental Falls
• Wearable Electronic Devices

Intervention

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.

Locations

Country	Name	City	State
Italy	S.C. Geriatria e Malattie Metaboliche dell'Osso U, A.O.U. Città della Salute e della Scienza di Torino	Torino	TO

Sponsors (3)

Lead Sponsor	Collaborator
Azienda Ospedaliera Città della Salute e della Scienza di Torino	Caretek S.r.l. Turin, Italy, Consoft Sistemi S.p.A. Turin, Italy

Country where clinical trial is conducted

Italy, 

References & Publications (4)

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. Review. — View 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. Epub 2007 Nov 20. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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

External Links

•   EuroQol EQ-5D