Clinical trial NCT06676839: Effectiveness of the WHO ICOPE (Integrated Care for Older People) Program in Preventing Age-related Functional Decline (ICOPE Trial.Fr)
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ageing
Keywords: ICOPE
PREVENTION
intrinsic capacity
healthy ageing
integrated care
elderly
functional decline
Multi component prevention program
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2024-11-06
Enrollment: 1000
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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 outcomes:
measure: Functional decline
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: Angers University hospital
city: Castres
country: France
facility: CHIC
city: Limoges
country: France
facility: Limoges university hospital
city: Perpignan
country: France
facility: Perpignan Hospital
city: Tarbes
country: France
facility: Bigorre Hospital
city: Toulouse
country: France
facility: CHU Toulouse
Study officials:
affiliation: CHU Toulouse
name: Laurent BALARDY, MD
role: PRINCIPAL_INVESTIGATOR
References: