Intrinsic CapacityICOPE-BRNCT06968702
Project ICOPE Brazil: Assessment of Intrinsic Capacity in Brazilian Older Adults
An observational study of Intrinsic Capacity and Frailty, run by University of Sao Paulo.
Trial summary
The ICOPE Brazil study aims to understand aging trajectories in Brazil, especially healthy aging trends based on intrinsic capacity, a collective of mental and physical capacities one may have to maintain their functional ability to execute daily life activities. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Intrinsic Capacity, Frailty, Aging
- How many people
- 3,838 participants
- Where
- No sites listed yet
- Study dates
- 15 May 2025to Nov 2029
- Phase
- Observational
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Community-dwelling people aged ≥ 60 years who are users of the public health system, and registered in the participating primary health care units domiciled in their respective coverage area.
Who may be able to join
- People aged ≥ 60 years, with no age limit;
- Being registered (with available contact information) in the participating health care units;
- Being available to go in person to the data collection sites for the assessments.
Who cannot join
- Inability to access the data collection site;
- Severe neurologic and/or cognitive impairments that preclude interaction with the evaluators to complete the proposed tests and data collections;
- Advanced serious illness or under palliative care:
- Clinical Frailty Scale (CFS)20 score of 8 (severely frail) or 9 (terminally ill).
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Project ICOPE Brazil: Assessment of Intrinsic Capacity in Older Adults as a Basis for Implementation of the WHO ICOPE Strategy in the Unified Health System.
The ICOPE Brazil study aims to understand aging trajectories in Brazil, especially healthy aging trends based on intrinsic capacity, a collective of mental and physical capacities one may have to maintain their functional ability to execute daily life activities. Tests and questionnaires will be applied to collect data on mobility capacity, cognitive capacity, nutritional status, vision, and hearing (sensorial) capacities, and mental health. These assessments are in consonance with what the World Health Organization proposed in the Integrated Care for Older People Program (ICOPE). Participants will be followed up for three years, and the primary outcomes of interest are loss of intrinsic capacity, mobility impairment, cognitive impairment, incident depressive symptoms, loss of functional ability, incident frailty, incident sarcopenia, incident falls, hospitalization, multimorbidity, and mortality.
Read the detailed description
The ICOPE Brazil study is a prospective, longitudinal cohort study designed to investigate the trajectories of aging among older adults in Brazil, with a particular emphasis on healthy aging as defined by the World Health Organization (WHO). The central conceptual framework guiding this study is "intrinsic capacity," a multidimensional construct encompassing an individual's physical and mental capacities that contribute to the maintenance of functional ability in later life.
Data collection will involve the administration of standardized tests and structured questionnaires to assess five core domains of intrinsic capacity: mobility, cognitive function, nutritional status, sensory capacities (vision and hearing), and psychological well-being. These domains reflect the recommendations outlined in the WHO's Integrated Care for Older People (ICOPE) program, which aims to promote healthy aging and support the functional ability of older populations globally.
Participants will be followed for a total duration of three years, with periodic assessments to monitor changes over time. The primary outcomes of interest include: decline in intrinsic capacity, mobility impairment, cognitive impairment, onset of depressive symptoms, loss of functional ability, incident frailty, incident sarcopenia, incidence of falls, hospitalizations, multimorbidity, and all-cause mortality. Data generated from this study will inform public health strategies, clinical guidelines, and policy development for aging populations in Brazil and other similar settings.
- Conditions
- Intrinsic Capacity, Frailty, Aging, Healthy Aging, Functional Ability, Mobility and Independence
- Keywords
- Instrinsic Capacity, Functional Ability, ICOPE, Aging trends, Older Adults, Frailty, Cognitive Impairment, Mobility, Sensory, Vitality, Psychological, Cohort, healthy aging, public health
- Medical subject headings
- Frailty, Cognitive Dysfunction, Hearing Loss, Sensorineural, Vision Disorders, Mood Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Community-dwelling older adults | Population Community-dwelling people aged ≥ 60 years registered in the participating primary health care units, and domiciled in their respective coverage area. Participants do not have to be active patients to be invited. We will create a random order from the lists of users registered in each health care unit involved in the project to invite participants. This approach ensures a systematic random sampling strategy to avoid participants' enrollment by convenience and its related selection bias. Participants will be invited via telephone or home visits, following the order established by the randomization list, until we reach the minimum expected number of participants for each center. For centers that need to enroll participants from two or more health care units to achieve the minimum expected sample size of 202 participants, it is necessary to consolidate the user lists from these units into a single list before randomization. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Loss of Intrinsic Capacity
Changes from baseline in Intrinsic Capacity domains over time. Mobility: delta of the Short Physical Performance Battery and its criterion. Cognition: delta of the Montreal Cognitive Assessment Score Vision: changes in visual acuity category assessed by the Snellen visual chart Hearing: changes in the Hearing Handicap Inventory For The Elderly category Nutrition/Vitality: changes in the Mini-nutritional risk category and the delta of its scores.
Depressive Symptoms: changes in the Geriatric Depression Scale results.
Measured: Participants will be reassessed by a telehealth visit at 6, 18, 30 months using the ICOPE basic assessment strategy. In-person visits at 12, 24 and 36 months of follow up.
Secondary outcomes (1)
Major Geriatric Outcomes
Major Geriatric Outcomes are:
Loss of Functional Ability Incident Falls Incident Fractures Urinary Incontinence Incident Frailty Incident Sarcopenia Incident Dementia Moving to a long-term care or Nursing Home facility Hospitalization ED visits Death
Measured: Telehealth monitoring at 6, 18, 30 months of follow up. In-person visits at 12, 24, 36 months of follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start15 May 2025 (estimated)
- Primary completionNov 2028 (estimated)
- Study completionNov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intrinsic CapacityStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,838 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eduardo Ferriolli, University of Sao Paulo
- Investigators
- Eduardo Ferriolli, MD, MSc, PhD, Study chair, University of Sao PauloRenato Bandeira de Mello, MD, MPH, PhD, Study director, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06968702
- Sponsor's protocol ID
- EFerriolli
- Acronym
- ICOPE-BR
- Status last verified
- May 2025
- First submitted
- 5 May 2025
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Assessment of intrinsic capacity in the Brazilian older population and the psychometric properties of the WHO/ ICOPE screening tool: a multicenter cohort study protocol. Geriatr Gerontol Aging. 2024; https://doi.org/10.53886/gga.e0000166_EN
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Project ICOPE Brazil: Assessment of Intrinsic Capacity in Older Adults as a Basis for Implementation of the WHO ICOPE Strategy in the Unified Health System.
- ClinicalTrials.gov ID
- NCT06968702
- Acronym / sponsor ID
- ICOPE-BR / EFerriolli
- Conditions
- Intrinsic Capacity, Frailty, Aging, Healthy Aging, Functional Ability, Mobility and Independence
- Keywords
- Instrinsic Capacity, Functional Ability, ICOPE, Aging trends, Older Adults, Frailty, Cognitive Impairment, Mobility
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 3,838 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 15 May 2025 (estimated)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Nov 2029 (estimated)
- First posted
- 13 May 2025 (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 ICOPE Brazil study aims to understand aging trajectories in Brazil, especially healthy aging trends based on intrinsic capacity, a collective of mental and physical capacities one may have to maintain their functional ability to execute daily life activities. Tests and questionnaires will be applied to collect data on mobility capacity, cognitive capacity, nutritional status, vision, and hearing (sensorial) capacities, and mental health. These assessments are in consonance with what the World Health Organization proposed in the Integrated Care for Older People Program (ICOPE). Participants will be followed up for three years, and the primary outcomes of interest are loss of intrinsic capacity, mobility impairment, cognitive impairment, incident depressive symptoms, loss of functional ability, incident frailty, incident sarcopenia, incident falls, hospitalization, multimorbidity, and mortality.
Detailed description
The ICOPE Brazil study is a prospective, longitudinal cohort study designed to investigate the trajectories of aging among older adults in Brazil, with a particular emphasis on healthy aging as defined by the World Health Organization (WHO). The central conceptual framework guiding this study is "intrinsic capacity," a multidimensional construct encompassing an individual's physical and mental capacities that contribute to the maintenance of functional ability in later life.
Data collection will involve the administration of standardized tests and structured questionnaires to assess five core domains of intrinsic capacity: mobility, cognitive function, nutritional status, sensory capacities (vision and hearing), and psychological well-being. These domains reflect the recommendations outlined in the WHO's Integrated Care for Older People (ICOPE) program, which aims to promote healthy aging and support the functional ability of older populations globally.
Participants will be followed for a total duration of three years, with periodic assessments to monitor changes over time. The primary outcomes of interest include: decline in intrinsic capacity, mobility impairment, cognitive impairment, onset of depressive symptoms, loss of functional ability, incident frailty, incident sarcopenia, incidence of falls, hospitalizations, multimorbidity, and all-cause mortality. Data generated from this study will inform public health strategies, clinical guidelines, and policy development for aging populations in Brazil and other similar settings.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Community-dwelling older adults | – | –Population Community-dwelling people aged ≥ 60 years registered in the participating primary health care units, and domiciled in their respective coverage area. Participants do not have to be active patients to be invited. We will create a random order from the lists of users registered in each health care unit involved in the project to invite participants. This approach ensures a systematic random sampling strategy to avoid participants' enrollment by convenience and its related selection bias. Participants will be invited via telephone or home visits, following the order established by the randomization list, until we reach the minimum expected number of participants for each center. For centers that need to enroll participants from two or more health care units to achieve the minimum expected sample size of 202 participants, it is necessary to consolidate the user lists from these units into a single list before randomization. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Community-dwelling people aged ≥ 60 years who are users of the public health system, and registered in the participating primary health care units domiciled in their respective coverage area.
Key inclusion criteria (3 listed)
- People aged ≥ 60 years, with no age limit;
- Being registered (with available contact information) in the participating health care units;
- Being available to go in person to the data collection sites for the assessments.
Key exclusion criteria (4 listed)
- Inability to access the data collection site;
- Severe neurologic and/or cognitive impairments that preclude interaction with the evaluators to complete the proposed tests and data collections;
- Advanced serious illness or under palliative care:
- Clinical Frailty Scale (CFS)20 score of 8 (severely frail) or 9 (terminally ill).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Loss of Intrinsic Capacity
Time frame: Participants will be reassessed by a telehealth visit at 6, 18, 30 months using the ICOPE basic assessment strategy. In-person visits at 12, 24 and 36 months of follow up.
Changes from baseline in Intrinsic Capacity domains over time. Mobility: delta of the Short Physical Performance Battery and its criterion. Cognition: delta of the Montreal Cognitive Assessment Score Vision: changes in visual acuity category assessed by the Snellen visual chart Hearing: changes in the Hearing Handicap Inventory For The Elderly category Nutrition/Vitality: changes in the Mini-nutritional risk category and the delta of its scores. Depressive Symptoms: changes in the Geriatric Depression Scale results.
1 secondary outcome
Major Geriatric Outcomes
Time frame: Telehealth monitoring at 6, 18, 30 months of follow up. In-person visits at 12, 24, 36 months of follow up
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 13 May 2025.
- BackgroundAssessment of intrinsic capacity in the Brazilian older population and the psychometric properties of the WHO/ ICOPE screening tool: a multicenter cohort study protocol. Geriatr Gerontol Aging. 2024; https://doi.org/10.53886/gga.e0000166_EN
- Study websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Eduardo Ferriolli, MD, MSc, PhD study chair
University of Sao Paulo
Renato Bandeira de Mello, MD, MPH, PhD study director
Federal University of Rio Grande do Sul
Questions about this trial
What is this clinical trial studying?
An observational study of Intrinsic Capacity and Frailty, run by University of Sao Paulo.
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 3 inclusion and 4 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: opening soon, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Eduardo Ferriolli, MD. MSc. PhD (5511 30616483, eferriol@fmrp.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Loss of Intrinsic Capacity (time frame: Participants will be reassessed by a telehealth visit at 6, 18, 30 months using the ICOPE basic assessment strategy. In-person visits at 12, 24 and 36 months of follow up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06968702, which also lists 1 linked publication.
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 13 May 2025.