NCT06004557

Brief 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) in the context of hospital consultations.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 9, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 22, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2024

Completed
Last Updated

August 24, 2023

Status Verified

August 1, 2023

Enrollment Period

6 months

First QC Date

August 9, 2023

Last Update Submit

August 22, 2023

Conditions

Keywords

Tabletmultidimensional assessmentgeriatricsconsultationValidation of a measurement tool

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    about 3 months

Secondary Outcomes (1)

  • Qualitative assessment

    about 3 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpitaux Universitaires Pitié Salpêtrière - Charles Foix et Sorbonne Université

Ivry-sur-Seine, 94200, France

RECRUITING

Central Study Contacts

Joël Belmin, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2023

First Posted

August 22, 2023

Study Start

July 1, 2023

Primary Completion

December 30, 2023

Study Completion

February 28, 2024

Last Updated

August 24, 2023

Record last verified: 2023-08

Locations