Fall PatientsPARCNCT03545529

Clinical and Medico-economic Evaluation of the Cohort "People at Risk of Falling"

A study testing Innovativ supported in people with Fall Patients, run by University Hospital, Grenoble at 3 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The goal of this study is to evaluate the effectiveness of the IsereADOM service package compared to conventional follow-up on the risk of recurrence of falls at 6 months in frail elderly subjects. Read more about this study

Who is it for?: Ages 65 years and older
Conditions the study is for: Fall Patients
What is being tested?: Innovativ supported
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 14 participants
Where: 3 sitesFrance
Study dates: 16 Feb 2018to 12 Oct 2019
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 65 years and older
All sexes
No healthy volunteers
Older adult

Who may be able to join

Patient falling at least 2 times in the year preceding the inclusion, one of them has been reported or consulted by a health care service ;
Patient fragile and loss of autonomy: level of dependence with GIR 3, 4 and 5 ;
Patient domiciled in the department of Isère ;
Patient who can be followed regularly for 6 months ;
Patient benefiting from an assistance plan : APA, PAP, CARSAT ;
Patient affiliated with social security or beneficiary of such a scheme ;
Patient able to read, write and understand French ;
Patient having signed informed consent to participate.

Who cannot join

Patient without professional or family carer of proximity ;
Patient with moderate to severe cognitive impairment defined by MMS <23 ;
Patient residing in a nursing home or institution for dependent person ;
Persons referred to in Articles L1121-5 to L1121-8 of the CSP (corresponds to all persons protected: pregnant woman, parturient, mother who is breastfeeding, person deprived of liberty by judicial or administrative decision, person subject of a legal protection measure).

Trial locations and contacts

3 sites in 1 country.

France3 sites

Centre Hospitalier Pierre Oudot
Bourgoin, 38300
CHU Grenoble-Alpes
Grenoble, 38043
Centre Hospitalier de Voiron
Voiron, 38500

Other trials in France

About this study

Official title: Medico-economic Assessment of a "IsereADOM" Package of Services Versus Conventional Monitoring in the Care of a Population of Frail Elderly People With Loss of Autonomy.

The goal of this study is to evaluate the effectiveness of the IsereADOM service package compared to conventional follow-up on the risk of recurrence of falls at 6 months in frail elderly subjects.

There is a medico-economic goal too, is to conduct a cost-utility analysis of the IsereADOM service bundle compared to conventional 6-month follow-up from the community perspective in the cheat population at risk of re-offending.

Conditions: Fall Patients
Being tested: Innovativ supported

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Innovativ supportedOther
addition of connected tools and stronger accompaniment to prevent falls

Study groups in NCT03545529
Study group	Role	What they receive
Innovative supported	Experimental	In addition to usual care, patients benefit from connected tools (telealarm, numeric communication diary...) and from a strong accompaniment with a referent person who help better the patient. Receives: Other: Innovativ supported
conventional supported	No intervention	Patients benefit from usual care

What is being measured

The primary outcome is the main question the study is designed to answer.

comparison of the number of falls according to the innovative or non-innovative care of frail elderly people
The outcome measure is the number of falls with hospitalization collected through administrative data from health facilities
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Feb 201812 Oct 2019

First posted4 Jun 2018
Study start16 Feb 2018
Primary completion12 Apr 2019
Study completion12 Oct 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Fall PatientsStudies of the same condition, open and under way.
More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
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: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03545529
Sponsor's protocol ID: 38RC16.044
Acronym: PARC
Status last verified: Dec 2019
First submitted: 28 Feb 2018
Last updated: 27 Dec 2019
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Gillespie LD, Robertson MC, Gillespie WJ, Sherrington C, Gates S, Clemson LM, Lamb SE. Interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2012 Sep 12;2012(9):CD007146. doi: 10.1002/14651858.CD007146.pub3.
PubMed 22972103
Moyer VA; U.S. Preventive Services Task Force. Prevention of falls in community-dwelling older adults: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2012 Aug 7;157(3):197-204. doi: 10.7326/0003-4819-157-3-201208070-00462.
PubMed 22868837
Gates S, Smith LA, Fisher JD, Lamb SE. Systematic review of accuracy of screening instruments for predicting fall risk among independently living older adults. J Rehabil Res Dev. 2008;45(8):1105-16.
PubMed 19235113
Payen JF, Chanques G, Mantz J, Hercule C, Auriant I, Leguillou JL, Binhas M, Genty C, Rolland C, Bosson JL. Current practices in sedation and analgesia for mechanically ventilated critically ill patients: a prospective multicenter patient-based study. Anesthesiology. 2007 Apr;106(4):687-95; quiz 891-2. doi: 10.1097/01.anes.0000264747.09017.da.
PubMed 17413906
Manca A, Hawkins N, Sculpher MJ. Estimating mean QALYs in trial-based cost-effectiveness analysis: the importance of controlling for baseline utility. Health Econ. 2005 May;14(5):487-96. doi: 10.1002/hec.944.
PubMed 15497198

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Fall Patients trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Medico-economic Assessment of a "IsereADOM" Package of Services Versus Conventional Monitoring in the Care of a Population of Frail Elderly People With Loss of Autonomy.
ClinicalTrials.gov ID: NCT03545529
Acronym / sponsor ID: PARC / 38RC16.044
Conditions: Fall Patients
Study type: Interventional
Recruitment status: Completed
Enrolment: 14 participants (actual)
Lead sponsor: University Hospital, GrenobleUniversity, hospital or other
Study start: 16 Feb 2018 (actual)
Primary completion: 12 Apr 2019 (actual)
Study completion: 12 Oct 2019 (actual)
First posted: 4 Jun 2018 (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.

The goal of this study is to evaluate the effectiveness of the IsereADOM service package compared to conventional follow-up on the risk of recurrence of falls at 6 months in frail elderly subjects.

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Innovative supported	Experimental	Other: Innovativ supportedIn addition to usual care, patients benefit from connected tools (telealarm, numeric communication diary...) and from a strong accompaniment with a referent person who help better the patient.
conventional supported	No intervention	–Patients benefit from usual care

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult

Key inclusion criteria (8 listed)

Patient falling at least 2 times in the year preceding the inclusion, one of them has been reported or consulted by a health care service ;
Patient fragile and loss of autonomy: level of dependence with GIR 3, 4 and 5 ;
Patient domiciled in the department of Isère ;
Patient who can be followed regularly for 6 months ;
Patient benefiting from an assistance plan : APA, PAP, CARSAT ;

Key exclusion criteria (4 listed)

Patient without professional or family carer of proximity ;
Patient with moderate to severe cognitive impairment defined by MMS <23 ;
Patient residing in a nursing home or institution for dependent person ;
Persons referred to in Articles L1121-5 to L1121-8 of the CSP (corresponds to all persons protected: pregnant woman, parturient, mother who is breastfeeding, person deprived of liberty by judicial or administrative decision, person subject of a legal protection measure).

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
Innovativ supportedaddition of connected tools and stronger accompaniment to prevent falls	Other	Innovative supported

Primary outcome

comparison of the number of falls according to the innovative or non-innovative care of frail elderly people
Time frame: 6 months
The outcome measure is the number of falls with hospitalization collected through administrative data from health facilities

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2019.
Background: PubMed 22972103Gillespie LD, Robertson MC, Gillespie WJ, Sherrington C, Gates S, Clemson LM, Lamb SE. Interventions for preventing falls in older people living in the community. Cochrane Database Syst Rev. 2012 Sep 12;2012(9):CD007146. doi: 10.1002/14651858.CD007146.pub3.
Background: PubMed 22868837Moyer VA; U.S. Preventive Services Task Force. Prevention of falls in community-dwelling older adults: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2012 Aug 7;157(3):197-204. doi: 10.7326/0003-4819-157-3-201208070-00462.
Background: PubMed 19235113Gates S, Smith LA, Fisher JD, Lamb SE. Systematic review of accuracy of screening instruments for predicting fall risk among independently living older adults. J Rehabil Res Dev. 2008;45(8):1105-16.
Background: PubMed 17413906Payen JF, Chanques G, Mantz J, Hercule C, Auriant I, Leguillou JL, Binhas M, Genty C, Rolland C, Bosson JL. Current practices in sedation and analgesia for mechanically ventilated critically ill patients: a prospective multicenter patient-based study. Anesthesiology. 2007 Apr;106(4):687-95; quiz 891-2. doi: 10.1097/01.anes.0000264747.09017.da.
Background: PubMed 15497198Manca A, Hawkins N, Sculpher MJ. Estimating mean QALYs in trial-based cost-effectiveness analysis: the importance of controlling for baseline utility. Health Econ. 2005 May;14(5):487-96. doi: 10.1002/hec.944.
Repérage et maintien de l'autonomie des personnes agées fragilesLink 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.

Pascal COUTURIER, MD principal investigator

CHU Grenoble Alpes

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Innovativ supported in people with Fall Patients, run by University Hospital, Grenoble at 3 sites in France.

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 8 inclusion and 4 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: finished, as of the sponsor's last update on 27 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in France. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

comparison of the number of falls according to the innovative or non-innovative care of frail elderly people (time frame: 6 months). 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 NCT03545529, which also lists 5 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 27 Dec 2019.