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

NCT06676839 | Recruiting

• 2 other identifiers: RC31/23/05972024-A00892-45
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Ageing

Keywords

ICOPE; PREVENTION; intrinsic capacity; healthy ageing; integrated care; elderly; functional decline; Multi component prevention program

Outcome Measures

Primary Outcomes (1)

• Functional decline

  Global functional decline is a composite measure derived from averaging the Z-score of 6 validated components (mobility : Short Physical Performance Battery), cognition (Mini Mental State Examination), nutrition (Mini Nutritional Assessment), vision (Snellen and Raskin), hearing (Hearing Handicap Inventory for the Elderly-Screening), and psychological well-being (Patient Health Questionnaire-9). Raw scores of each of the 6 tests are converted to Z-scores using means and standard deviations at baseline for each test (to have a same unit for all test).

  36 months

Study Arms (2)

Intervention group

EXPERIMENTAL

Participants will receive the complete ICOPE intervention, personalized to their deficit during 60 months (36 months, followed by a 24-month extension) The intervention include : 1) a screening (every 6 months), using the ICOPE tool 2) a comprehensive assessment of the 6 functions; 3) a personalized intervention aimed at correcting the trajectory of functional decline, based on the participants' choices and preferences; 4) a follow-up of the intervention. All results are communicated to the primary care physician. Follow-up visits take place annually at 12, 24, 36, 48 and 60 months. Data related to the outcomes are collected by the research nurse, blinded to the randomization arm. Participants will benefit from telephone follow-up 1.5 months after the inclusion visit and between each visit at 6, 18, 30, 42, and 54 months, to support them in implementing their personalized intervention plan and to collect life events occurred between the 2 visits.

Other: the complete ICOPE program

Control group

NO INTERVENTION

During the comparative phase, participants randomized into the Control group will be referred to their primary care physician to receive usual care tailored to their health status. During the 24 months-extension phase they will benefit from the complete ICOPE as defined in the intervention group. Follow-up visits take place annually at 12, 24, 36, 48 and 60 months. Data related to the outcomes are collected by the research nurse, blinded to the randomization arm. The team will schedule phone calls for all participants at 6, 18, 30, 42, and 54 months to record life events. During the extension phase, participants will benefit from phone call follow-up between each annual visit at 42 months and 54 months, to support their personalized intervention plan.

Interventions

the complete ICOPE program OTHER

The participant benefits from a personalized intervention, including 1) a screening to be repeated every 6 months, based on the use of the ICOPE tool, allowing an assessment of the 6 functions necessary for an autonomous lifestyle; 2) a comprehensive assessment step for the 6 functions 3) a personalized intervention step aimed at correcting the trajectory of functional decline, based on the participants' preferences; 4) a follow-up step for this intervention. Participants will benefit from telephone follow-up 1.5 months after the start of the program and between each annual visit to support them in implementing their personalized intervention plan. At each contact, the ICOPE nurse reviews the participant's implementation of the personalized intervention plan recommendations and their adherence to the program. The results of the assessment and the proposed intervention are communicated and discussed with the primary care physician and a summary letter is also sent.

Intervention group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Participants aged 65 years and older.
• Participants living independently at home (ADL = 6, except for an occasional urinary abnormality which will be accepted).
• Participants showing functional decline in at least 2 of the 6 functional domains of ICOPE (mobility, cognition, nutrition, vision, hearing, and psychological well-being) identified using the ICOPE screening tool.
• Participants affiliated with a social protection system.

You may not qualify if:

• Participants who has already benefited from the ICOPE program or who has completed more than one isolated step 1
• Participants living in a dependent elderly care facility.
• Participants with a disability preventing them from reaching the trial examination center without assistance (such as dementia or significant mobility impairment).
• Participants with hearing, visual, or speech impairments preventing them from understanding instructions or communicating with study staff.
• Participants with a life-threatening illness with a prognosis of less than 5 years.
• Participants unable to provide informed written consent.
• Participants under legal protection, guardianship, or trusteeship.
• Participants participating in another interventional research study.
• Participants in a relationship with a person participating in the study.

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (6)

CHIC

Castres, France, 81108, France

RECRUITING

Perpignan Hospital

Perpignan, France, 66046, France

RECRUITING

Bigorre Hospital

Tarbes, France, 65000, France

RECRUITING

CHU Toulouse

Toulouse, France, 31000, France

RECRUITING

Angers University hospital

Angers, 49933, France

RECRUITING

Limoges university hospital

Limoges, 87042, France

RECRUITING

Study Officials

• Laurent BALARDY, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laurent BALARDY, MD

CONTACT

05 61 77 64 95; balardy.l@chu-toulouse.fr

Elodie LESTIME

CONTACT

05 61 77 84 16; lestime.e@chu-toulouse.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants, physicians, and healthcare professionals will be informed of the allocation of the subjects' group membership after randomization. However, research nurses who will collect data on the primary and secondary outcomes during visits common to all subjects in the trial will be blinded to the subjects' group assignment. Participants and their caregivers will be asked to avoid mentioning the type of treatment they are receiving to the research nurse conducting the interview.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2024
• First Posted: November 6, 2024
• Study Start: October 14, 2024
• Primary Completion (Estimated): October 14, 2031
• Study Completion (Estimated): October 31, 2031
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (6)