Program to prevent functional decline in older adults
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
This study tests whether a special program can help older adults living at home stay independent and healthy compared to regular care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | University Hospital, Toulouse Academic / other |
| Locations | 6 sites (Castres, France and 5 other locations) |
| Trial ID | NCT06676839 on ClinicalTrials.gov |
What this trial studies
The ICOPE program, developed by the World Health Organization, aims to maintain the autonomy of elderly individuals by addressing age-related functional decline. This multicenter, randomized trial compares the effectiveness of the comprehensive ICOPE intervention against usual care for individuals aged 70 and over living at home. Participants will undergo a screening process to identify deficits in six functional domains, followed by personalized care plans if needed. The study includes regular follow-ups to assess functional outcomes over a period of five years.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 65 and older who live independently and show functional decline in at least two of the six assessed domains.
Not a fit: Patients living in dependent care facilities or those with severe disabilities preventing participation will not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly enhance the quality of life and independence of older adults by preventing functional decline.
How similar studies have performed: Other studies have shown promise in integrated care approaches for elderly populations, suggesting potential success for this program.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Castres, France and 5 other locations
- Chic — Castres, France, France (Recruiting)
- Perpignan Hospital — Perpignan, France, France (Recruiting)
- Bigorre Hospital — Tarbes, France, France (Recruiting)
- CHU Toulouse — Toulouse, France, France (Recruiting)
- Angers University hospital — Angers, France (Recruiting)
- Limoges university hospital — Limoges, France (Recruiting)
Study contacts
- Principal investigator: Laurent BALARDY, MD — University Hospital, Toulouse
- Study coordinator: Laurent BALARDY, MD
- Email: balardy.l@chu-toulouse.fr
- Phone: 05 61 77 64 95
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.