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

ConditionAgeing
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorUniversity Hospital, Toulouse

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • the complete ICOPE program

    Other intervention

    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.

Treatment groups

1,000 Participants
are divided into 2 treatment groups
Group A: Intervention groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Functional decline

Global functional decline is a composite measure derived from averaging the Z-score of 6 validated components (mobility : Short Physical Performance Battery), cognition (Mini Mental State Examination), nutrition (Mini Nutritional Assessment), vision (Snellen and Raskin), hearing (Hearing Handicap Inventory for the Elderly-Screening), and psychological well-being (Patient Health Questionnaire-9). Raw scores of each of the 6 tests are converted to Z-scores using means and standard deviations at baseline for each test (to have a same unit for all test).

Time frame
36 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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