Project ICOPE Brazil: Assessment of Intrinsic Capacity in Brazilian Older Adults (ICOPE-BR)

May 5, 2025 updated by: Eduardo Ferriolli, University of Sao Paulo

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.

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.

Study Overview

Status

Not yet recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

3838

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Renato Bandeira de Mello, MD. MPH. PhD.
  • Phone Number: 555133598572
  • Email: rgmello@hcpa.edu.br

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.

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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Major Geriatric Outcomes
Time Frame: 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
Telehealth monitoring at 6, 18, 30 months of follow up. In-person visits at 12, 24, 36 months of follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Investigators

  • Study Chair: Eduardo Ferriolli, MD, MSc, PhD, University of São Paulo
  • Study Director: Renato Bandeira de Mello, MD, MPH, PhD, Federal University of Rio Grande do Sul

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 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

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 15, 2025

Primary Completion (Estimated)

November 1, 2028

Study Completion (Estimated)

November 1, 2029

Study Registration Dates

First Submitted

May 5, 2025

First Submitted That Met QC Criteria

May 5, 2025

First Posted (Actual)

May 13, 2025

Study Record Updates

Last Update Posted (Actual)

May 13, 2025

Last Update Submitted That Met QC Criteria

May 5, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EFerriolli

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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