Improving the Referral of Patients With Suspected Cognitive Impairment and Early Dementia

Summary

The goal of this interventional study is to implement and evaluate the adhesion to two types of interventional strategies for assessing cognitive function, at Family Health Units (FHU), providing primary care clinicians (PCCs) with support to the decision process, regarding the referral of patients suspected of having mild cognitive impairment (MCI) or early dementia to the specialized consultation of Neurology at the public hospital services. The defined intervention strategies are the paper version of the cognitive tests MMSE and MoCA -group MoCA/MMSE -and the class I digital medical device web-based Brain on Track - group Brain on Track/MoCA/MMSE -, which will be compared with the regular clinical practice as the Control Group.

The main question it aims to answer is:

• the impact on the referral process of the implemented cognitive assessment strategies in the two interventional study groups compared with the Control Group.

Trained health professionals, at FHU, will administer the cognitive tests mentioned above to the eligible patients suspected of having MCI or early dementia, in the interventional groups and, according to the respective results and other criteria used during the consultation, PCCs will decide about the need of referral to the Neurology consultation. In the Control Group, health professionals will provide the regular clinical assistance practised in the respective FHU. If the referral occurs, the Neurology specialist will perform a complete clinical neuropsychological assessment of the referred patients and will validate the suspected diagnosis made at FHU.

Eligible patients with suspected MCI or early dementia will perform the cognitive tests according to the interventional study group, at the FHU or remotely. In the Control Group, eligible patients will be assisted through the daily clinical practice in the respective FHU.

The research team will compare the interventional study groups with the Control Group, to see if there is an improvement on the referral process in the interventional groups, compared with the Control Group .

Conditions

• Cognitive Dysfunction
• Mild Cognitive Impairment

Interventions

DIAGNOSTIC_TEST

Mini Mental State Examination

MMSE is a clinically validated cognitive test, broadly used in healthcare and scientific settings, and it is administered to individuals with cognitive complaints suspected of cognitive decline whose educational literacy is of three to four years of schooling. It is validated in the general Portuguese population and can discriminate normal cognition from dementia.

DIAGNOSTIC_TEST

Montreal Cognitive Assessment

MoCA is a clinically validated cognitive test, broadly used in healthcare and scientific settings, and it is administered to individuals with cognitive complaints suspected of cognitive decline whose educational literacy is, at least, of four years of schooling. It is validated in general Portuguese population and can discriminate MCI from dementia.

DEVICE

Brain on Track (version BOT.0.0.0 03.03.2023)

Brain on Track is a class I web-based software medical device, accessible on most platforms, including desktops and laptops. It is designed to allow periodic self-administered cognitive tests to be performed, enabling a cognitive assessment and continuous monitoring of the cognitive state of the patient remotely. It is based on the classic tests of neuropsychological assessment and allows assessing the main areas of cognition through a test lasting approximately 22 minutes. The stimuli that integrate each subtest are randomized between sessions, which reduces the effect of learning and allows the accomplishment of serial assessments.The test is available in three versions, adapted to different levels of schooling: 1-4 years, 5-9 years and 10+ years. The performance in each test is compared with normative population data and performance over time. For each test performed, Brain on Track presents a cumulative risk score for the presence of cognitive impairment.

Sponsors & Collaborators

• Unidade Local de Saúde de Matosinhos, EPE

  collaborator OTHER

• Instituto de Saude Publica da Universidade do Porto

  collaborator OTHER

• Universidade do Porto

  lead OTHER

Principal Investigators

• Luís Ruano, PhD · Institute of Public Health of University of Porto

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-03-01

Primary Completion

2026-06-30

Completion

2026-09-30

Countries

• Portugal

Study Locations