Actively Recruiting
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
Led by University Hospital, Toulouse · Updated on 2026-03-23
1000
Participants Needed
6
Research Sites
2 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the World Health Organization's Integrated Care for Older People (ICOPE) program to see if it helps prevent age-related decline in older adults. This study compares the comprehensive ICOPE program with usual care from primary doctors. The goal is to determine if regular screening, personalized care plans, and follow-up can better maintain functions like mobility, cognition, and nutrition in people aged 65 and older living at home. The trial randomly assigns participants to either receive the full ICOPE program or usual care. The ICOPE program includes screening every six months using a digital tool, a thorough assessment of six key functions, a personalized intervention plan, and ongoing follow-up, including phone calls and annual visits over 60 months. After an initial 36-month intervention, all participants receive the ICOPE program during a 24-month extension phase. Participants have annual visits at 12, 24, 36, 48, and 60 months, during which a research nurse collects data while unaware of which group they are in. Phone calls occur between visits to support the care plan and gather information about life events. The primary outcome measured is functional decline at 36 months. The study runs until 2031, with continuous monitoring of participants' health and program adherence.
CONDITIONS
Brief Title
Effectiveness of the WHO ICOPE (Integrated Care for Older People) Program in Preventing Age-related Functional Decline (ICOPE Trial.Fr)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants aged 65 years and older
- Living independently at home with full daily living activities except occasional urinary issues allowed
- Showing functional decline in at least 2 of 6 areas: mobility, cognition, nutrition, vision, hearing, psychological well-being
- Affiliated with a social protection system
You will not qualify if you...
- Already participated in the ICOPE program or completed more than one isolated step
- Living in a dependent elderly care facility
- Having disabilities preventing reaching the trial center unaided, such as dementia or major mobility problems
- Hearing, vision, or speech impairments that prevent understanding instructions or communication
- Life-threatening illness with prognosis under 5 years
- Unable to provide written informed consent
- Under legal protection, guardianship, or trusteeship
- Participating in another interventional research study
- In a relationship with a person participating in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 36 months
Participants in the intervention group receive the complete ICOPE program personalized to their functional deficits. This includes repeated screenings every 6 months using the ICOPE tool, comprehensive assessments, personalized interventions to correct functional decline, and follow-up support including telephone calls to assist with intervention adherence. Control group participants receive usual care from their primary care physician during the first 36 months.
Annual visits at 12, 24, and 36 months; telephone follow-ups at 1.5, 6, 18, and 30 months
Duration - 24 months
After the initial 36-month treatment phase, all participants receive the complete ICOPE program during a 24-month extension phase with continued annual visits and telephone follow-ups to support ongoing intervention adherence and collect life events.
Annual visits at 48 and 60 months; telephone follow-ups at 42 and 54 months
Trial Site Locations
Total: 6 locations
1
CHIC
Castres, France, France, 81108
Actively Recruiting
2
Perpignan Hospital
Perpignan, France, France, 66046
Actively Recruiting
3
Bigorre Hospital
Tarbes, France, France, 65000
Actively Recruiting
4
CHU Toulouse
Toulouse, France, France, 31000
Actively Recruiting
5
Angers University hospital
Angers, France, 49933
Actively Recruiting
6
Limoges university hospital
Limoges, France, 87042
Actively Recruiting
Research Team
L
Laurent BALARDY, MD
E
Elodie LESTIME
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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