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

Last updated: February 10, 2025
Sponsor: University Hospital, Toulouse
Overall Status: Active - Recruiting

Phase

N/A

Condition

Aging

Treatment

the complete ICOPE program

Clinical Study ID

NCT06676839
RC31/23/0597
2024-A00892-45
  • Ages > 65
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Participants aged 65 years and older.

  2. Participants living independently at home (ADL = 6, except for an occasional urinaryabnormality which will be accepted).

  3. Participants showing functional decline in at least 2 of the 6 functional domains ofICOPE (mobility, cognition, nutrition, vision, hearing, and psychologicalwell-being) identified using the ICOPE screening tool.

  4. Participants affiliated with a social protection system.

Exclusion

Exclusion Criteria:

  1. Participants who has already benefited from the ICOPE program or who has completedmore than one isolated step 1

  2. Participants living in a dependent elderly care facility.

  3. Participants with a disability preventing them from reaching the trial examinationcenter without assistance (such as dementia or significant mobility impairment).

  4. Participants with hearing, visual, or speech impairments preventing them fromunderstanding instructions or communicating with study staff.

  5. Participants with a life-threatening illness with a prognosis of less than 5 years.

  6. Participants unable to provide informed written consent.

  7. Participants under legal protection, guardianship, or trusteeship.

  8. Participants participating in another interventional research study.

  9. Participants in a relationship with a person participating in the study.

Study Design

Total Participants: 1000
Treatment Group(s): 1
Primary Treatment: the complete ICOPE program
Phase:
Study Start date:
October 14, 2024
Estimated Completion Date:
October 31, 2031

Study Description

ICOPE Trail.Fr is a comparative, multicenter, randomized (1:1), two-arm parallel intervention trial, stratified by center and the number of impairments present at inclusion, open-label, controlled, comparing the effectiveness of the comprehensive ICOPE strategy in preventing functional decline in elderly individuals aged 70 and over living at home, versus the usual care provided by their primary care physician.

Participants will be randomized either 1) into the Intervention group, where they will receive the comprehensive ICOPE intervention program, adapted and personalized to their areas of deficit, or 2) into the Control group, where they will be referred to their primary care physician to receive usual care tailored to their health status.

Follow-up visits take place at the investigator's center at V2 (12 months), V3 (24 months), V4 (36 months), V5 (48 months), and V6 (60 months). Data related to functional scales are collected by the research nurse, who is blinded to the randomization results.

Phone calls will be at 6 (A1), 18 (A2), 30 (A3), 42 (A4), and 54 (A5) months to collect relevant life events.

The intervention duration is 36 months, followed by a 24-month extension phase during which all study participants will receive the comprehensive ICOPE intervention.

Connect with a study center

  • Angers University hospital

    Angers, 49933
    France

    Site Not Available

  • CHIC

    Castres, 81108
    France

    Site Not Available

  • Limoges university hospital

    Limoges, 87042
    France

    Active - Recruiting

  • Perpignan Hospital

    Perpignan, 66046
    France

    Active - Recruiting

  • Bigorre Hospital

    Tarbes, 65000
    France

    Active - Recruiting

  • CHU Toulouse

    Toulouse, 31000
    France

    Active - Recruiting

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