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

Study acronym: DemRefImprov
StatusUnknown
PhaseNot applicable
Started

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.

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Record History

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  1. Minor Changed Registry marked status Unknown (sponsor has not verified the record since May 2023); last known: Not Yet Recruiting
  2. Notable Primary completion date: Dec 31, 2025 to Jun 30, 2026v4 Show 6 more changesShow less
    • Start date: Dec 1, 2023 to Mar 1, 2024
    • Primary endpoints: 2 to 9
    • Study completion date: Jun 30, 2026 to Sep 30, 2026
    • Eligibility criteria shortened, about 11 words
    • Secondary endpoints: 13 to 2
    • Study description shortened, about 69 words
  3. Notable Start date: Jul 1, 2023 to Dec 1, 2023v3
  4. Minor Secondary endpoints: 9 to 13
    • Eligibility criteria expanded, about 2 words
    • Study description shortened, about 2 words
    v2
  5. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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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 .
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
(from sponsor)
Cognitive Dysfunction, Mild Cognitive Impairment
Related terms Cognitive Dysfunction, Dementia
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov