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Clinical Trials in France / NCT06676839
Recruiting Not applicable

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

NCT06676839 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2024-10-14
Last updated
2026-03-23

Condition(s) studied

Ageing

Investigational drug(s) / intervention(s)

the complete ICOPE program

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.

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

Sex
ALL
Min age
65 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Participants aged 65 years and older. 2. Participants living independently at home (ADL = 6, except for an occasional urinary abnormality which will be accepted). 3. 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. 4. Participants affiliated with a social protection system. Exclusion Criteria: 1. Participants who has already benefited from the ICOPE program or who has completed more 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 examination center without assistance (such as dementia or significant mobility impairment). 4. Participants with hearing, visual, or speech impairments preventing them from understanding 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.

Primary outcome measure(s)

Trial sites (6)

FacilityCityRegionStatus
CHIC Castres France Recruiting
Perpignan Hospital Perpignan France Recruiting
Bigorre Hospital Tarbes France Recruiting
CHU Toulouse Toulouse France Recruiting
Angers University hospital Angers France Recruiting
Limoges university hospital Limoges France Recruiting

More University Hospital, Toulouse trials in France

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06676839 on ClinicalTrials.gov ↗ ← All trials in France