Clinical trial NCT06968702: Project ICOPE Brazil: Assessment of Intrinsic Capacity in Brazilian Older Adults
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.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
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
Keywords: Instrinsic Capacity
Functional Ability
ICOPE
Aging trends
Older Adults
Frailty
Cognitive Impairment
Mobility
Sensory
Vitality
Psychological
Cohort
healthy aging
public health
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2025-05-13
Enrollment: 3838
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Loss of Intrinsic Capacity
timeFrame: 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:
measure: Major Geriatric Outcomes
timeFrame: Telehealth monitoring at 6, 18, 30 months of follow up. In-person visits at 12, 24, 36 months of follow up
Other outcomes:
Locations:
Study officials:
affiliation: University of Sao Paulo
name: Eduardo Ferriolli, MD, MSc, PhD
role: STUDY_CHAIR
affiliation: Federal University of Rio Grande do Sul
name: Renato Bandeira de Mello, MD, MPH, PhD
role: STUDY_DIRECTOR
References:
citation: 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