Project ICOPE Brazil: Assessment of Intrinsic Capacity in Brazilian Older Adults
- Conditions
- Depressive SymptomsVitalityNutritional RiskNutrition AssessmentIntrinsic CapacityCognitive Ability, GeneralFrailtyAgingHealthy AgingSensory Deficits
- Registration Number
- NCT06968702
- Lead Sponsor
- University of Sao Paulo
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 3838
- 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).
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Loss of Intrinsic Capacity 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.
- Secondary Outcome Measures
Name Time Method Major Geriatric Outcomes Telehealth monitoring at 6, 18, 30 months of follow up. In-person visits at 12, 24, 36 months of follow up 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