Elderly People in a Consultation ContextNCT06004557
Validation of a Digital Multidimensional Assessment Tool for the Elderly in Geriatric Consultations
An observational study of Elderly People in a Consultation Context, run by RIVAGES at 1 site in France.
Trial summary
The aim of this study is to validate a digital multidimensional assessment tool for elderly people in geriatric consultations. The aim is to use a digital tablet to rapidly assess several risks (loss of functional independence, risk of falling, risk of malnutrition, risk of depression and risk of burden for the carer)… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Elderly People in a Consultation Context
- How many people
- 160 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2023to 28 Feb 2024
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: We would like to offer this study to patients who come to us with memory problems, in accordance with the inclusion criteria set out above. If they are unable to take part, and if family carers are available, they will be able to fill in the questionnaire on a tablet.
Who may be able to join
- People aged over 65 attending a geriatric consultation (if patient)
- Person agreeing to take part in the study and having signed the letter of consent (if patient)
- Person caring for an elderly person (if family caregiver)
- Someone who visits their relative at least once a week (if family caregiver)
- Person agreeing to take part in the study and to complete the evaluation tool in paper format and on a tablet for their relative (if family caregiver)
Who cannot join
- Incapacity to consent (if patient)
- Refusal to take part in the study (if patient)
- Person under legal protection (if patient)
- People in palliative care (if patient)
- Person who usually has little contact with the patient (if family caregiver)
- Refusal to take part in the study (if family caregiver)
- Incapacity to consent (if family caregiver)
- Person under legal protection (if family caregiver)
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpitaux Universitaires Pitié Salpêtrière - Charles Foix et Sorbonne Université
Ivry-sur-Seine, 94200
Joël Belmin, +33149594565, j.belmin@gmail.com
About this study
Official title: Validation d'un Outil numérique d'évaluation Multidimensionnelle Pour Les Personnes âgées Dans un Contexte de Consultations gériatriques
The aim of this study is to validate a digital multidimensional assessment tool for elderly people in geriatric consultations. The aim is to use a digital tablet to rapidly assess several risks (loss of functional independence, risk of falling, risk of malnutrition, risk of depression and risk of burden for the carer) in the context of hospital consultations.
Read the detailed description
The use of digital tools on tablets to gather information from patients is on the increase. Numerous computerised tools exist for identifying health problems and have been validated in the medical world. However, there are currently no digital tools adapted to the elderly in a consultation context. In this project, the investigators want to carry out a cross-sectional observational study to assess the validity of a multidimensional assessment tool on a tablet, self-administered by patients or carers, and also the appropriateness of using it with these groups.
Objectives Multidimensional assessment tools have the advantage of enabling several issues to be addressed systematically. In this research, the investigators want to assess the validity of a multidimensional assessment tool in digital format in a population of elderly people and carers. To do this, the investigators intend to use scales that already exist and are usually used in paper format: the ADL and IADL for dependency, the Mini MNA for nutrition, the Cornell and GDS-15 for depression, the mini Zarit for estimating the burden on carers and the Cetaf score and short FES-I for the risk of falling. These assessment tools have been adapted to digital format and brought together to form a comprehensive multidimensional assessment tool.
The investigators' first objective was to assess the validity of this set of scales in digital format compared with their original paper versions, but the investigators also want to measure the acceptability of this assessment tool in a geriatric population and among family carers. In addition, the investigators plan to assess the adaptability of this tool and its compatibility in a geriatric consultation setting. Finally, the investigators want to measure doctors' satisfaction with the collection of this information, as a time-saving tool for these professionals.
Methods Eighty patients and eighty carers will be included in this study, recruited from the geriatric consultation service (outpatient geriatrics department) at Charles Foix Hospital. These will be people aged over 65, and family carers if it is not possible to carry out the test on a self-administered basis.
To do this, the investigators are planning a quantitative study to compare the scores obtained by the digital version of the test with the data described by the doctors in the reports, and in particular the same scales systematically filled in by the medical profession. In addition, the investigators want to analyse what users say and assess their experience of practical issues (grip, legibility, impression of confidentiality when filling in the form in the waiting room, etc.).
Outlook A multi-theme self-questionnaire assessment of elderly people and their carers waiting for a consultation would save professionals time (in terms of completion time and calculation of results), make data more secure, save paper and provide a complete and systematic scan of a number of potentially serious risks.
- Conditions
- Elderly People in a Consultation Context
- Keywords
- Tablet, multidimensional assessment, geriatrics, consultation, Validation of a measurement tool
What is being measured
The primary outcome is the main question the study is designed to answer.
Tests used to compare results between the digital version (tablet) and results from healthcare profession
Calculation of the interclass correlation coefficient (ICC), a statistical method for estimating the equivalence of scores obtained from electronic versions.
Measured: about 3 months
Method used to compare and visualise discrepancies between the results of the digital version (tablet) and the results of healthcare professionals
Bland and Altman concordance method, graph showing the differences between the scores obtained by the two scales for each observation.
Measured: about 3 months
Secondary outcomes (1)
Qualitative assessment
Final questionnaire to evaluate user experimentation
Measured: about 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2023
- Study start1 Jul 2023
- Primary completion30 Dec 2023 (estimated)
- Study completion28 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elderly People in a Consultation ContextStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RIVAGES
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06004557
- Sponsor's protocol ID
- 2022-A02818-35
- Status last verified
- Aug 2023
- First submitted
- 9 Aug 2023
- Last updated
- 24 Aug 2023
- 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 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation d'un Outil numérique d'évaluation Multidimensionnelle Pour Les Personnes âgées Dans un Contexte de Consultations gériatriques
- ClinicalTrials.gov ID
- NCT06004557
- Acronym / sponsor ID
- 2022-A02818-35
- Conditions
- Elderly People in a Consultation Context
- Keywords
- Tablet, multidimensional assessment, geriatrics, consultation, Validation of a measurement tool
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- RIVAGESUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 28 Feb 2024 (estimated)
- First posted
- 22 Aug 2023 (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 aim of this study is to validate a digital multidimensional assessment tool for elderly people in geriatric consultations. The aim is to use a digital tablet to rapidly assess several risks (loss of functional independence, risk of falling, risk of malnutrition, risk of depression and risk of burden for the carer) in the context of hospital consultations.
Detailed description
The use of digital tools on tablets to gather information from patients is on the increase. Numerous computerised tools exist for identifying health problems and have been validated in the medical world. However, there are currently no digital tools adapted to the elderly in a consultation context. In this project, the investigators want to carry out a cross-sectional observational study to assess the validity of a multidimensional assessment tool on a tablet, self-administered by patients or carers, and also the appropriateness of using it with these groups.
Objectives Multidimensional assessment tools have the advantage of enabling several issues to be addressed systematically. In this research, the investigators want to assess the validity of a multidimensional assessment tool in digital format in a population of elderly people and carers. To do this, the investigators intend to use scales that already exist and are usually used in paper format: the ADL and IADL for dependency, the Mini MNA for nutrition, the Cornell and GDS-15 for depression, the mini Zarit for estimating the burden on carers and the Cetaf score and short FES-I for the risk of falling. These assessment tools have been adapted to digital format and brought together to form a comprehensive multidimensional assessment tool.
The investigators' first objective was to assess the validity of this set of scales in digital format compared with their original paper versions, but the investigators also want to measure the acceptability of this assessment tool in a geriatric population and among family carers. In addition, the investigators plan to assess the adaptability of this tool and its compatibility in a geriatric consultation setting. Finally, the investigators want to measure doctors' satisfaction with the collection of this information, as a time-saving tool for these professionals.
Methods Eighty patients and eighty carers will be included in this study, recruited from the geriatric consultation service (outpatient geriatrics department) at Charles Foix Hospital. These will be people aged over 65, and family carers if it is not possible to carry out the test on a self-administered basis.
To do this, the investigators are planning a quantitative study to compare the scores obtained by the digital version of the test with the data described by the doctors in the reports, and in particular the same scales systematically filled in by the medical profession. In addition, the investigators want to analyse what users say and assess their experience of practical issues (grip, legibility, impression of confidentiality when filling in the form in the waiting room, etc.).
Outlook A multi-theme self-questionnaire assessment of elderly people and their carers waiting for a consultation would save professionals time (in terms of completion time and calculation of results), make data more secure, save paper and provide a complete and systematic scan of a number of potentially serious risks.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- We would like to offer this study to patients who come to us with memory problems, in accordance with the inclusion criteria set out above. If they are unable to take part, and if family carers are available, they will be able to fill in the questionnaire on a tablet.
Key inclusion criteria (5 listed)
- People aged over 65 attending a geriatric consultation (if patient)
- Person agreeing to take part in the study and having signed the letter of consent (if patient)
- Person caring for an elderly person (if family caregiver)
- Someone who visits their relative at least once a week (if family caregiver)
- Person agreeing to take part in the study and to complete the evaluation tool in paper format and on a tablet for their relative (if family caregiver)
Key exclusion criteria (8 listed)
- Incapacity to consent (if patient)
- Refusal to take part in the study (if patient)
- Person under legal protection (if patient)
- People in palliative care (if patient)
- Person who usually has little contact with the patient (if family caregiver)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Tests used to compare results between the digital version (tablet) and results from healthcare profession
Time frame: about 3 months
Calculation of the interclass correlation coefficient (ICC), a statistical method for estimating the equivalence of scores obtained from electronic versions.
Method used to compare and visualise discrepancies between the results of the digital version (tablet) and the results of healthcare professionals
Time frame: about 3 months
Bland and Altman concordance method, graph showing the differences between the scores obtained by the two scales for each observation.
1 secondary outcome
Qualitative assessment
Time frame: about 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2023.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Elderly People in a Consultation Context, run by RIVAGES 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 5 inclusion and 8 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 24 Aug 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joël Belmin, Professor (0033149594565, j.belmin@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tests used to compare results between the digital version (tablet) and results from healthcare profession (time frame: about 3 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?
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 24 Aug 2023; AzTrials last refreshed its copy on 30 Oct 2026.