Accidental FallsADAMONCT04398615
Validation of the ADAMO Watch for the Early Detection of Fall Events in Older Patients
A study testing Wearable watch device in people with Accidental Falls and Wearable Electronic Devices, run by A.O.U. Città della Salute e della Scienza at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 75 years and olderHealthy volunteers can take part
- Conditions the study is for
- Accidental Falls, Wearable Electronic Devices
- What is being tested?
- Wearable watch device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 25 May 2020to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Aged 75 years and older
- At least 2 fall events during the 12 months previous to enrollment
- Signed written informed consent
Who cannot join
- Severe cognitive impairment
- Bedridden condition
- Patients unable to walk autonomously (walking aids allowed)
Trial locations and contacts
1 site in 1 country.
Italy1 site
S.C. Geriatria e Malattie Metaboliche dell'Osso U, A.O.U. Città della Salute e della Scienza di Torino
Torino, TO, 10126
Renata Marinello, MD, PhD, 0116334771 ext. +39, rmarinello@cittadellasalute.to.it
About this study
Official title: Validazione Dell'Orologio ADAMO Per l'Individuazione Precoce Delle Cadute Nel Paziente Anziano
"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
- Being tested
- Wearable watch device
- Keywords
- Aged, Telemetry, Wearable Electronic Devices, Fall detection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable watch deviceDevice
Also called ADAMO
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Single arm, receiving the experimental device Receives: Device: Wearable watch device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 months
Secondary outcomes (2)
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)
Measured: At enrollment and at 6 months
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)
Measured: At enrollment and at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start25 May 2020 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Accidental FallsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- A.O.U. Città della Salute e della Scienza
- Sponsor type
- University, hospital or other
- Collaborators
- Caretek S.r.l. Turin, Italy, Consoft Sistemi S.p.A. Turin, Italy
- Responsible party
- Principal investigator, Dott.ssa RENATA MARINELLO, A.O.U. Città della Salute e della Scienza
- Investigators
- Renata Marinello, MD, PhD, Principal investigator, OAU Città della Salute e della Scienza di Torino, Turin, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04398615
- Sponsor's protocol ID
- ADAMO
- Acronym
- ADAMO
- Status last verified
- May 2020
- First submitted
- 15 May 2020
- Last updated
- 21 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 18194967Kempen 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.
PubMed 18032400Podsiadlo 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.
PubMed 1991946Ganz 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.
PubMed 16398908
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validazione Dell'Orologio ADAMO Per l'Individuazione Precoce Delle Cadute Nel Paziente Anziano
- ClinicalTrials.gov ID
- NCT04398615
- Acronym / sponsor ID
- ADAMO / ADAMO
- Conditions
- Accidental Falls, Wearable Electronic Devices
- Keywords
- Aged, Telemetry, Wearable Electronic Devices, Fall detection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- A.O.U. Città della Salute e della ScienzaUniversity, hospital or other
- Collaborators
- Caretek S.r.l. Turin, Italy, Consoft Sistemi S.p.A. Turin, Italy
- Study start
- 25 May 2020 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 21 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
"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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Wearable watch deviceSingle arm, receiving the experimental device |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Aged 75 years and older
- At least 2 fall events during the 12 months previous to enrollment
- Signed written informed consent
Key exclusion criteria (3 listed)
- Severe cognitive impairment
- Bedridden condition
- Patients unable to walk autonomously (walking aids allowed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wearable watch deviceAlso: ADAMOEvery 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. | Device | Intervention |
Primary outcome
Incidence of self-reported fall events
Time frame: 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
Time frame: 6 months
Fall event incidence automatically evaluated by the wearable watch device, based on biometric data continuously recorded from enrollment through to 6 months.
2 secondary outcomes
Variation in quality of life reported at three levels EQ-5D (EQ-5D-5L) Questionnaire
Time frame: At enrollment and at 6 months
Variation in fear of falling evaluated with Short Falls Efficacy Scale International (Short FES-I)
Time frame: At enrollment and at 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2020.
- Background: PubMed 18194967Scheffer 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.
- Background: PubMed 18032400Kempen 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.
- Background: PubMed 1991946Podsiadlo 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.
- Background: PubMed 16398908Ganz 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.
- EuroQol EQ-5DLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Renata Marinello, MD, PhD principal investigator
OAU Città della Salute e della Scienza di Torino, Turin, Italy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wearable watch device in people with Accidental Falls and Wearable Electronic Devices, run by A.O.U. Città della Salute e della Scienza at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Renata Marinello, MD, PhD (0116334771 ext. +39, rmarinello@cittadellasalute.to.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of self-reported fall events (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04398615, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2020.