Project ICOPE Brazil: Assessment of Intrinsic Capacity in Brazilian Older Adults
ICOPE-BR
1 other identifier
observational
3,838
0 countries
N/A
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2025
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 5, 2025
CompletedFirst Posted
Study publicly available on registry
May 13, 2025
CompletedStudy Start
First participant enrolled
May 15, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2029
May 13, 2025
May 1, 2025
3.5 years
May 5, 2025
May 5, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
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
Telehealth monitoring at 6, 18, 30 months of follow up. In-person visits at 12, 24, 36 months of follow up
Study Arms (1)
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.
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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
BACKGROUND
Related Links
Biospecimen
Blood Plasma specimens
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Eduardo Ferriolli, MD, MSc, PhD
University of Sao Paulo
- STUDY DIRECTOR
Renato Bandeira de Mello, MD, MPH, PhD
Federal University of Rio Grande do Sul
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Full Professor
Study Record Dates
First Submitted
May 5, 2025
First Posted
May 13, 2025
Study Start
May 15, 2025
Primary Completion (Estimated)
November 1, 2028
Study Completion (Estimated)
November 1, 2029
Last Updated
May 13, 2025
Record last verified: 2025-05