Actively Recruiting

Phase Not Applicable
Age: 65Years +
All Genders
NCT06676839

Effectiveness of the WHO ICOPE (Integrated Care for Older People) Program in Preventing Age-related Functional Decline (ICOPE Trial.Fr)

Led by University Hospital, Toulouse · Updated on 2026-03-23

1000

Participants Needed

6

Research Sites

367 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

The World Health Organization (WHO) has designed an integrated care program (ICOPE) aimed at maintaining the functions of elderly people to preserve their autonomy. It includes four steps (Screening, Comprehensive Assessment, Personalized Prevention and Care Plan, Follow-up). The screening tool assesses a person's intrinsic capacity in six key functional domains (mobility, cognition, nutrition, vision, hearing, psychological well-being). This screening can be conducted by a professional or through self-assessment using the digital application (ICOPE Monitor). If a deficit is detected, an alert is issued, and if confirmed by a healthcare professional trained in ICOPE, a comprehensive assessment of the impaired function and a personalized prevention and care plan is proposed by the physician. A trained nurse assists the person in implementing this plan in collaboration with the primary care physician and local professionals. When multiple functions are impaired, it is recommended to conduct a thorough evaluation of all six functions to implement an integrated approach. The clinical effectiveness of the program in preventing functional decline has not yet been established in a sufficiently long trial. The investigators propose to evaluate the effect and cost of the ICOPE program in France through a controlled trial. Our hypothesis is that, in the current primary care context, the comprehensive implementation of the program (combining regular screening, comprehensive assessment, prevention and care plan, and follow-up) is necessary to more effectively prevent age-related functional decline compared to the usual care provided by the primary care physician.

CONDITIONS

Official Title

Effectiveness of the WHO ICOPE (Integrated Care for Older People) Program in Preventing Age-related Functional Decline (ICOPE Trial.Fr)

Who Can Participate

Age: 65Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants aged 65 years and older.
  • Participants living independently at home with full ability to perform daily activities (ADL = 6), except occasional urinary abnormalities.
  • Participants showing functional decline in at least two of the six ICOPE functional domains (mobility, cognition, nutrition, vision, hearing, psychological well-being) identified by the ICOPE screening tool.
  • Participants affiliated with a social protection system.
Not Eligible

You will not qualify if you...

  • Participants who have already received the ICOPE program or completed more than one isolated step.
  • Participants living in dependent elderly care facilities.
  • Participants with disabilities preventing them from reaching the trial center without help (e.g., dementia or significant mobility impairment).
  • Participants with hearing, vision, or speech impairments that prevent understanding instructions or communicating with study staff.
  • Participants with a life-threatening illness with prognosis under 5 years.
  • Participants unable to provide informed written consent.
  • Participants under legal protection, guardianship, or trusteeship.
  • Participants currently in another interventional research study.
  • Participants in a relationship with another study participant.

AI-Screening

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Trial Site Locations

Total: 6 locations

1

CHIC

Castres, France, France, 81108

Actively Recruiting

2

Perpignan Hospital

Perpignan, France, France, 66046

Actively Recruiting

3

Bigorre Hospital

Tarbes, France, France, 65000

Actively Recruiting

4

CHU Toulouse

Toulouse, France, France, 31000

Actively Recruiting

5

Angers University hospital

Angers, France, 49933

Actively Recruiting

6

Limoges university hospital

Limoges, France, 87042

Actively Recruiting

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Research Team

L

Laurent BALARDY, MD

CONTACT

E

Elodie LESTIME

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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