Project ICOPE Brazil: Assessment of Intrinsic Capacity in Brazilian Older Adults

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age60+
SponsorUniversity of Sao Paulo

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

3,838 Participants
are grouped into 1 trial group
Group A: Community-dwelling older adults

Trial outcomes

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.

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.

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

Time frame
Telehealth monitoring at 6, 18, 30 months of follow up. In-person visits at 12, 24, 36 months of follow up

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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