AgeingICOPE FrNCT06676839
Effectiveness of the WHO ICOPE (Integrated Care for Older People) Program in Preventing Age-related Functional Decline (ICOPE Trial.Fr)
A study testing the complete ICOPE program in people with Ageing, run by University Hospital, Toulouse at 6 sites in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Ageing
- What is being tested?
- the complete ICOPE program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 6 sitesFrance
- Study dates
- 14 Oct 2024to 31 Oct 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
France6 sites, 6 recruiting
- Recruiting
Angers University hospital
Angers, 49933
Cédric Annweiler, MD, 02 41 35 47 25 ext. +33, cedric.Annweiler@chu-angers.fr
CEDRIC ANNWEILER, MD
- Recruiting
CHIC
Castres, France, 81108
Marie-Noëlle Cufi, MD, 05 63 71 62 72 ext. +33, marie-noelle.cufi@chic-cm.fr
Marie-Noëlle CUFI, MD
- Recruiting
Limoges university hospital
Limoges, 87042
Achille TCHALLA, MD, 05 55 05 86 26 ext. +33, achille.tchalla@unilim.fr
ACHILLE TCHALLA, MD
- Recruiting
Perpignan Hospital
Perpignan, France, 66046
Geneviève BARNIER-FIGUE, MD, 04 68 61 89 45 ext. +33, caroline.bonhoure@ch-perpignan.fr
Caroline BONHOURE, MD
- Recruiting
Bigorre Hospital
Tarbes, France, 65000
Yannick GASNIER, MD, 05 62 54 70 15 ext. +33, ygasnier@ch-tarbes-vic.fr
Yannick GASNIER, MD
- Recruiting
CHU Toulouse
Toulouse, France, 31000
Laurent BALARDY, MD, 05 61 77 64 95 ext. +33, balardy.l@chu-toulouse.fr
Elodie LESTIME, 05 61 77 84 16 ext. +33, lestime.e@chu-toulouse.fr
About this study
Official title: 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
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.
Read the detailed description
ICOPE Trail.Fr is a comparative, multicenter, randomized (1:1), two-arm parallel intervention trial, stratified by center and the number of impairments present at inclusion, open-label, controlled, comparing the effectiveness of the comprehensive ICOPE strategy in preventing functional decline in elderly individuals aged 70 and over living at home, versus the usual care provided by their primary care physician.
Participants will be randomized either 1) into the Intervention group, where they will receive the comprehensive ICOPE intervention program, adapted and personalized to their areas of deficit, or 2) into the Control group, where they will be referred to their primary care physician to receive usual care tailored to their health status.
Follow-up visits take place at the investigator's center at V2 (12 months), V3 (24 months), V4 (36 months), V5 (48 months), and V6 (60 months). Data related to functional scales are collected by the research nurse, who is blinded to the randomization results.
Phone calls will be at 6 (A1), 18 (A2), 30 (A3), 42 (A4), and 54 (A5) months to collect relevant life events.
The intervention duration is 36 months, followed by a 24-month extension phase during which all study participants will receive the comprehensive ICOPE intervention.
- Conditions
- Ageing
- Being tested
- the complete ICOPE program
- Keywords
- ICOPE, PREVENTION, intrinsic capacity, healthy ageing, integrated care, elderly, functional decline, Multi component prevention program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the complete ICOPE programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Participants will receive the complete ICOPE intervention, personalized to their deficit during 60 months (36 months, followed by a 24-month extension)
The intervention include : 1) a screening (every 6 months), using the ICOPE tool 2) a comprehensive assessment of the 6 functions; 3) a personalized intervention aimed at correcting the trajectory of functional decline, based on the participants' choices and preferences; 4) a follow-up of the intervention. All results are communicated to the primary care physician.
Follow-up visits take place annually at 12, 24, 36, 48 and 60 months. Data related to the outcomes are collected by the research nurse, blinded to the randomization arm.
Participants will benefit from telephone follow-up 1.5 months after the inclusion visit and between each visit at 6, 18, 30, 42, and 54 months, to support them in implementing their personalized intervention plan and to collect life events occurred between the 2 visits. Receives: Other: the complete ICOPE program |
| Control group | No intervention | During the comparative phase, participants randomized into the Control group will be referred to their primary care physician to receive usual care tailored to their health status. During the 24 months-extension phase they will benefit from the complete ICOPE as defined in the intervention group. Follow-up visits take place annually at 12, 24, 36, 48 and 60 months. Data related to the outcomes are collected by the research nurse, blinded to the randomization arm. The team will schedule phone calls for all participants at 6, 18, 30, 42, and 54 months to record life events. During the extension phase, participants will benefit from phone call follow-up between each annual visit at 42 months and 54 months, to support their personalized intervention plan. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2024
- Study start14 Oct 2024
- Primary completion14 Oct 2031 (estimated)
- Study completion31 Oct 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgeingStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurent BALARDY, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06676839
- Sponsor's protocol ID
- RC31/23/0597
- Other IDs
- 2024-A00892-45
- Acronym
- ICOPE Fr
- Status last verified
- Mar 2026
- First submitted
- 15 Oct 2024
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06676839
- Acronym / sponsor ID
- ICOPE Fr / RC31/23/0597
- Conditions
- Ageing
- Keywords
- ICOPE, PREVENTION, intrinsic capacity, healthy ageing, integrated care, elderly, functional decline, Multi component prevention program
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 14 Oct 2024 (actual)
- Primary completion
- 14 Oct 2031 (estimated)
- Study completion
- 31 Oct 2031 (estimated)
- First posted
- 6 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
ICOPE Trail.Fr is a comparative, multicenter, randomized (1:1), two-arm parallel intervention trial, stratified by center and the number of impairments present at inclusion, open-label, controlled, comparing the effectiveness of the comprehensive ICOPE strategy in preventing functional decline in elderly individuals aged 70 and over living at home, versus the usual care provided by their primary care physician.
Participants will be randomized either 1) into the Intervention group, where they will receive the comprehensive ICOPE intervention program, adapted and personalized to their areas of deficit, or 2) into the Control group, where they will be referred to their primary care physician to receive usual care tailored to their health status.
Follow-up visits take place at the investigator's center at V2 (12 months), V3 (24 months), V4 (36 months), V5 (48 months), and V6 (60 months). Data related to functional scales are collected by the research nurse, who is blinded to the randomization results.
Phone calls will be at 6 (A1), 18 (A2), 30 (A3), 42 (A4), and 54 (A5) months to collect relevant life events.
The intervention duration is 36 months, followed by a 24-month extension phase during which all study participants will receive the comprehensive ICOPE intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: the complete ICOPE programParticipants will receive the complete ICOPE intervention, personalized to their deficit during 60 months (36 months, followed by a 24-month extension) The intervention include : 1) a screening (every 6 months), using the ICOPE tool 2) a comprehensive assessment of the 6 functions; 3) a personalized intervention aimed at correcting the trajectory of functional decline, based on the participants' choices and preferences; 4) a follow-up of the intervention. All results are communicated to the primary care physician. Follow-up visits take place annually at 12, 24, 36, 48 and 60 months. Data related to the outcomes are collected by the research nurse, blinded to the randomization arm. Participants will benefit from telephone follow-up 1.5 months after the inclusion visit and between each visit at 6, 18, 30, 42, and 54 months, to support them in implementing their personalized intervention plan and to collect life events occurred between the 2 visits. |
| Control group | No intervention | –During the comparative phase, participants randomized into the Control group will be referred to their primary care physician to receive usual care tailored to their health status. During the 24 months-extension phase they will benefit from the complete ICOPE as defined in the intervention group. Follow-up visits take place annually at 12, 24, 36, 48 and 60 months. Data related to the outcomes are collected by the research nurse, blinded to the randomization arm. The team will schedule phone calls for all participants at 6, 18, 30, 42, and 54 months to record life events. During the extension phase, participants will benefit from phone call follow-up between each annual visit at 42 months and 54 months, to support their personalized intervention plan. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| the complete ICOPE programThe 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. | Other | Intervention group |
Primary outcome
Functional decline
Time frame: 36 months
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Laurent BALARDY, MD principal investigator
University Hospital, Toulouse
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the complete ICOPE program in people with Ageing, run by University Hospital, Toulouse at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laurent BALARDY, MD (05 61 77 64 95 ext. +33, balardy.l@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional decline (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2026.