Accidental Falls, Wearable Electronic Devices
Conditions
Keywords
Aged, Telemetry, Wearable Electronic Devices, Fall detection
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.
Interventions
DEVICEWearable 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.
Sponsors
Caretek S.r.l. Turin, Italy
Consoft Sistemi S.p.A. Turin, Italy
A.O.U. Città della Salute e della Scienza
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
During the follow-up period both healthcare personnel and investigators will not be aware of data (including fall events) registered by the experimental device.
Eligibility
Sex/Gender
ALL
Age
75 Years to No maximum
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of self-reported fall events | 6 months | 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. |
| Incidence of device-reported fall events | 6 months | Fall event incidence automatically evaluated by the wearable watch device, based on biometric data continuously recorded from enrollment through to 6 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Variation in quality of life reported at three levels EQ-5D (EQ-5D-5L) Questionnaire | At enrollment and at 6 months | 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) |
| Variation in fear of falling evaluated with Short Falls Efficacy Scale International (Short FES-I) | At enrollment and at 6 months | 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) |
Countries
Italy
Contacts
Primary ContactRenata Marinello, MD, PhD
Outcome results
None listed