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

Sponsor
University of Sao Paulo
Study ID
NCT06968702
Status
Not Yet Recruiting

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Conditions

  • Aging
  • Cognitive Ability, General
  • Cognitive Impairment
  • Depressive Symptoms
  • Frailty
  • Functional Ability
  • Healthy Aging
  • Intrinsic Capacity
  • Mobility and Independence
  • Mood Disorders
  • Nutrition Assessment
  • Nutritional Risk
  • Sensory Deficits
  • Sensory Hearing Loss
  • Visual Acuity
  • Visual Impairment
  • Vitality

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

First listed
May 13, 2025
Start date
May 15, 2025
Status verified
May 2025
Primary completion
Nov 30, 2028
Completion
Nov 30, 2029

Study Design

Enrollment
3,838 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

Loss of Intrinsic Capacity [ 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. ]

Central Contacts

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