NCT06676839 Effectiveness of the WHO ICOPE (Integrated Care for Older People) Program in Preventing Age-related Functional Decline (ICOPE Trial.Fr)
| NCT ID | NCT06676839 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Toulouse |
| Condition | Ageing |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2024-10-14 |
| Primary Completion | 2031-10-14 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,000 participants in total. It began in 2024-10-14 with a primary completion date of 2031-10-14.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Laurent BALARDY, MD
PRINCIPAL INVESTIGATOR
University Hospital, Toulouse
Frequently Asked Questions
Who can join the NCT06676839 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Ageing. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06676839 currently recruiting?
Yes, NCT06676839 is actively recruiting participants. Contact the research team at balardy.l@chu-toulouse.fr for enrollment information.
Where is the NCT06676839 trial being conducted?
This trial is being conducted at Castres, France, Perpignan, France, Tarbes, France, Toulouse, France and 2 additional locations.
Who is sponsoring the NCT06676839 clinical trial?
NCT06676839 is sponsored by University Hospital, Toulouse. The principal investigator is Laurent BALARDY, MD at University Hospital, Toulouse. The trial plans to enroll 1,000 participants.