NCT06676839

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

Effectiveness of the WHO ICOPE (Integrated Care for Older People) Program in Preventing Age-related Functional Decline: a 36-month Randomized Controlled Trial With a 24-month Extension

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,000 (estimated)
• Sponsor: University Hospital, Toulouse · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Ageing

Interventions

Type	Name	Description
OTHER	the complete ICOPE program	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.

Timeline

• Start date: 2024-10-14
• Primary completion: 2031-10-14
• Completion: 2031-10-31
• First posted: 2024-11-06
• Last updated: 2026-03-23

Locations

6 sites across 1 country: France