RecruitingNot ApplicableNCT06676839

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

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


Sponsor

University Hospital, Toulouse

Enrollment

1,000 participants

Start Date

Oct 14, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 65 Years

Inclusion Criteria4

  • Participants aged 65 years and older.
  • Participants living independently at home (ADL = 6, except for an occasional urinary abnormality which will be accepted).
  • 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.
  • Participants affiliated with a social protection system.

Exclusion Criteria9

  • Participants who has already benefited from the ICOPE program or who has completed more than one isolated step 1
  • Participants living in a dependent elderly care facility.
  • Participants with a disability preventing them from reaching the trial examination center without assistance (such as dementia or significant mobility impairment).
  • Participants with hearing, visual, or speech impairments preventing them from understanding instructions or communicating with study staff.
  • Participants with a life-threatening illness with a prognosis of less than 5 years.
  • Participants unable to provide informed written consent.
  • Participants under legal protection, guardianship, or trusteeship.
  • Participants participating in another interventional research study.
  • Participants in a relationship with a person participating in the study.

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Interventions

OTHERthe 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.


Locations(6)

CHIC

Castres, France, France

Perpignan Hospital

Perpignan, France, France

Bigorre Hospital

Tarbes, France, France

CHU Toulouse

Toulouse, France, France

Angers University hospital

Angers, France

Limoges university hospital

Limoges, France

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NCT06676839


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