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.
| Registry | NCT06968702, acronym ICOPE-BR |
|---|---|
| Status | Not yet recruiting |
| Study type | Observational |
| Enrollment | 3838 (Estimated) |
| Sponsor | University of Sao Paulo (Other) |
| Conditions | Intrinsic Capacity, Frailty, Aging, Healthy Aging, Functional Ability, Mobility and Independence, Cognitive Ability, General, Cognitive Impairment, Sensory Hearing Loss, Sensory Deficits, Visual Acuity, Visual Impairment, Mood Disorders, Depressive Symptoms, Vitality, Nutritional Risk, Nutrition Assessment |
| Dates | start 2025-05-15 (estimated), primary completion 2028-11-01 (estimated), completion 2029-11-01 (estimated), first posted 2025-05-13, last updated 2025-05-13 |
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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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| 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. |
Sex: All, ages: 60 Years to any
Inclusion Criteria: * 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. Exclusion criteria * 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).