ElderlyFRAGIL-ITNCT03468647
Seamless Follow up and Support System for Frail Elderly Living at Home
A study testing soles, weighting machine and gripping force in people with Elderly, run by University Hospital, Toulouse at 1 site in France.
Trial summary
The object of the present project is to promote the prevention of disability by providing 1) a feedback and motivational coaching to the user, 2) relevant clinical parameters to the healthcare professionals in order to support the patient's follow-up, and 3) supporting the detection of preliminary signs of functional… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Elderly
- What is being tested?
- soles, weighting machine and gripping force
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 16 Oct 2017to 31 Dec 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 living at home;
- pre-frail or frail volunteers;
- Informed and written consent by the patient or the legal representative or the reliable person when appropriate.
Who cannot join
- patient's life expectancy less than 12 months; patient presenting disability with an Activity of Daily Living score < 4/6 ant/or a Mini - Mental State <20/30, not walking or walking with a technical support;
- Non agreement of study participation of patients or legal representative or the reliable person when appropriate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: FRAGIL-IT, Seamless Follow up and Support System for Frail Elderly Living at Home
The object of the present project is to promote the prevention of disability by providing 1) a feedback and motivational coaching to the user, 2) relevant clinical parameters to the healthcare professionals in order to support the patient's follow-up, and 3) supporting the detection of preliminary signs of functional loss. The technical solution will contain wearable (e.g. smart insole) and ambient unobtrusive devices (e.g. weigh scale including balance analysis), and analysis and diagnosis assistance software. The devices transmit wirelessly the collected data to a remote server through a tablet. Data will then be available remotely for consultations by users (i.e. patients or physicians). The clinical evaluation will be a multi-phased design with a first living lab evaluation followed by a real life home trial to finalize the evaluation. Comprehensive assessments will be conducted to highlight the feasibility and acceptability.
Read the detailed description
Functional decline challenges the sustainability of healthcare systems. There are difficulties in implementing effective interventions to prevent disability, to promote adherence to lifestyle recommendations and to perform seamless follow-up at home. A technological solution addressing this challenge and improving individual participation would be welcome. Our aim is to evaluate an instrument for supporting physical activity and monitoring multiple parameters of frailty (a pre-disability condition) in frail elderly persons. The investigator and collaborator are therefore developing a solution to monitor key parameters of frailty during subject daily life and to promote walking. This tools are :
- connected soles to evaluate different parameters of the volunteer walking
- connected weighing machine to evaluate the volunteer weight and equilibrate
- machine to measure gripping force because gripping force is correlated to physical condition.
The primary aim is to assess the acceptability of the solution for the follow up and the motivational coaching of frail patients at home. Results from this study will also be used to elaborate the design of a further larger national multicenter randomized control trial assessing the efficiency of the solution to prevent disability.
- Conditions
- Elderly
- Being tested
- soles, weighting machine, gripping force
- Keywords
- frailty, tele-monitoring, self-management
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
solesOther
Also called connected soles
Volunteer must walk this this connected seamless to measure different walking parameters
weighting machineOther
Also called connected weighting machine
This weighting machine measure weight evolution and equilibrate of volunteers
gripping forceOther
Also called gripping force machine
this machine measure the gripping force of volunteer
| Study group | Role | What they receive |
|---|---|---|
| FRAGIL-IT testing group | Experimental | FRAGIL-IT tools : connected soles, connected weighting machine and measure of gripping force Receives: Other: soles; Other: weighting machine; Other: gripping force |
What is being measured
The primary outcome is the main question the study is designed to answer.
acceptability of FRAGIL-IT tools
primary outcome is based on the acceptability of the FRAGIL-IT tools for the end-user : connected soles, connected weighting machine and measure of gripping force to control autonomy loss. The acceptability of this tools will be evaluate by questionnaire as The Short Form (36) Health Survey (SF36) questionnaire
Measured: 3 months
Secondary outcomes (4)
evaluation of life quality with SF36 questionnaire
the life quality will be assess with SF36 questionnaire
Measured: 3 months
functional status measure by ADL
functional status will be assess with Activity of Daily Living (ADL) score. The scale of ADL is between 0 to 6. 0 is worse than 6.
Measured: 3 months
functional status measure by iADL
functional status will be assess with instrumental Activity of Daily Living (iADL) score. The scale of IADL is between 0 to 8. 0 is worse than 8.
Measured: 3 months
cognitive status
cognitive status will be assess with Mini Mental State (MMS)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2018
- Study start16 Oct 2017
- Primary completion31 Dec 2018
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ElderlyStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antoine PIAU, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03468647
- Sponsor's protocol ID
- RC31/15/0603
- Acronym
- FRAGIL-IT
- Status last verified
- Nov 2020
- First submitted
- 13 Oct 2017
- Last updated
- 9 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FRAGIL-IT, Seamless Follow up and Support System for Frail Elderly Living at Home
- ClinicalTrials.gov ID
- NCT03468647
- Acronym / sponsor ID
- FRAGIL-IT / RC31/15/0603
- Conditions
- Elderly
- Keywords
- frailty, tele-monitoring, self-management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 16 Oct 2017 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 16 Mar 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 object of the present project is to promote the prevention of disability by providing 1) a feedback and motivational coaching to the user, 2) relevant clinical parameters to the healthcare professionals in order to support the patient's follow-up, and 3) supporting the detection of preliminary signs of functional loss. The technical solution will contain wearable (e.g. smart insole) and ambient unobtrusive devices (e.g. weigh scale including balance analysis), and analysis and diagnosis assistance software. The devices transmit wirelessly the collected data to a remote server through a tablet. Data will then be available remotely for consultations by users (i.e. patients or physicians). The clinical evaluation will be a multi-phased design with a first living lab evaluation followed by a real life home trial to finalize the evaluation. Comprehensive assessments will be conducted to highlight the feasibility and acceptability.
Detailed description
Functional decline challenges the sustainability of healthcare systems. There are difficulties in implementing effective interventions to prevent disability, to promote adherence to lifestyle recommendations and to perform seamless follow-up at home. A technological solution addressing this challenge and improving individual participation would be welcome. Our aim is to evaluate an instrument for supporting physical activity and monitoring multiple parameters of frailty (a pre-disability condition) in frail elderly persons. The investigator and collaborator are therefore developing a solution to monitor key parameters of frailty during subject daily life and to promote walking. This tools are :
- connected soles to evaluate different parameters of the volunteer walking
- connected weighing machine to evaluate the volunteer weight and equilibrate
- machine to measure gripping force because gripping force is correlated to physical condition.
The primary aim is to assess the acceptability of the solution for the follow up and the motivational coaching of frail patients at home. Results from this study will also be used to elaborate the design of a further larger national multicenter randomized control trial assessing the efficiency of the solution to prevent disability.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FRAGIL-IT testing group | Experimental | Other: soles, Other: weighting machine, Other: gripping forceFRAGIL-IT tools : connected soles, connected weighting machine and measure of gripping force |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- patient living at home;
- pre-frail or frail volunteers;
- Informed and written consent by the patient or the legal representative or the reliable person when appropriate.
Key exclusion criteria (2 listed)
- patient's life expectancy less than 12 months; patient presenting disability with an Activity of Daily Living score < 4/6 ant/or a Mini - Mental State <20/30, not walking or walking with a technical support;
- Non agreement of study participation of patients or legal representative or the reliable person when appropriate.
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 |
|---|---|---|
| solesAlso: connected solesVolunteer must walk this this connected seamless to measure different walking parameters | Other | FRAGIL-IT testing group |
| weighting machineAlso: connected weighting machineThis weighting machine measure weight evolution and equilibrate of volunteers | Other | FRAGIL-IT testing group |
| gripping forceAlso: gripping force machinethis machine measure the gripping force of volunteer | Other | FRAGIL-IT testing group |
Primary outcome
acceptability of FRAGIL-IT tools
Time frame: 3 months
primary outcome is based on the acceptability of the FRAGIL-IT tools for the end-user : connected soles, connected weighting machine and measure of gripping force to control autonomy loss. The acceptability of this tools will be evaluate by questionnaire as The Short Form (36) Health Survey (SF36) questionnaire
4 secondary outcomes
evaluation of life quality with SF36 questionnaire
Time frame: 3 months
functional status measure by ADL
Time frame: 3 months
functional status measure by iADL
Time frame: 3 months
cognitive status
Time frame: 3 months
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 9 Nov 2020.
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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.
Antoine PIAU, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing soles, weighting machine and gripping force in people with Elderly, run by University Hospital, Toulouse at 1 site 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 3 inclusion and 2 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 9 Nov 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 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?
acceptability of FRAGIL-IT tools (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Nov 2020.