Clinical Trial

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

Study acronym: DemRefImprov
Not Yet Recruiting
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Record status
This record was last updated January 25, 2024 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.
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 .
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2023-05-25; most recent amendment 2024-01-24.
Trial Details
NCT Number NCT05890313
Lead Sponsor Universidade do Porto
Collaborators: Unidade Local de Saúde de Matosinhos, EPE, Instituto de Saude Publica da Universidade do Porto
Conditions Cognitive Dysfunction, Mild Cognitive Impairment
Enrollment 60 participants
Start Date 2024-03-01
Primary Completion 2026-06-30 (estimated)
Study Completion 2026-09-30 (estimated)
Updated on ClinicalTrials.gov 2024-01-25