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

NCT05890313 | Not Yet Recruiting

• 1 other identifier: DemRefImprov
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

mild cognitive impairment; early dementia; timely diagnosis; primary care; referral process

Outcome Measures

Primary Outcomes (9)

• Positive predictive value of the implemented interventional strategies

  To determine the capacity of MMSE, MoCA and Brain on Track of detecting the true positive cases of MCI among the total positive cases of suspected cognitive impairment

  18 months

• Adhesion of PCCs to the three cognitive interventions implemented

  Number of MoCA/MMSE/Brain on Track tests prescribed by PCCs to the recruited patients (with inclusion criteria and who accept to participate in the study) per month

  12 months

• Adhesion of patients to remote monitorization with Brain on Track

  Number of remote monitorization sessions with Brain on Track accomplished by each patient allocated to the follow-up period of 12 months/4

  12 months

• Referrals decided by PCCs in all study groups

  Number of referrals decided by PCCs in each study group of patients who are eligible and accept to participate in the study, per month

  24 months

• Average number of MoCA/MMSE/Brain on Track tests prescribed by PCCs in the 12-month period of implementation/Average number of MoCA/MMSE/Brain on Track tests prescribed by PCCs at baseline

  Evaluation of the adhesion to the cognitive tests implemented during the 12-month period of the study in comparison to the adhesion existent before the implementation of the study

  12 months

• Average number of referrals decided by PCCs in each group of the study in the total temporal period of the study/Average number of referrals decided by PCCs at baseline

  Evaluation of the impact of the implemented interventions on the quantity of referred patients suspected of a diagnosis of MCI or early dementia, during the 12-month period of implementation, taking into account the comparison to the same average quantity before the implementation of the study

  24 months

• Number of referrals decided by PCCs based mainly on the result of the cognitive intervention administered/Total number of decisions of referral * 100

  Evaluation of the impact of the result obtained from the cognitive interventions administered on the clinical decision of referral made by PCCs

  24 months

• Number of correct referrals decided by PCCs based mainly on the result of the cognitive intervention administered/Number of correct referrals decided by PCCs in the Control group * 100

  Evaluation of the impact of the cognitive interventions administered and their result on the clinical decision of referral made by PCCs in comparison to the impact of regular clinical practice on the same type of clinical decision

  36 months

• Proportion of new cases diagnosed with dementia, in the different stages of progression: mild, moderate and severe

  To determine the proportion of incident cases of dementia, from early to severe stages, among the patients referred to specialized care

  18 months

Secondary Outcomes (2)

• Adhesion to interventional strategies by health professionals

  At one-year of recruitment

• Adhesion to Brain on Track by patients allocated to remote follow-up

  At the end of the remote monitoring period of 12 months with Brain on Track

Study Arms (3)

Group MoCA/MMSE (Interventional Group)

EXPERIMENTAL

A training session about dementia management and standardized criteria for referral will be provided to participant PCCs, complemented with training in the administration of MMSE and MoCA, provided also to resident clinicians responsible for administration of the tests. MMSE will be administered if the patient has three to four years of schooling, and the MoCA will be used if the patient has more than four years of schooling. Patients with less than three years of education will be evaluated through regular clinical practice.

Diagnostic Test: Mini Mental State Examination; Diagnostic Test: Montreal Cognitive Assessment

Group Brain on Track/MoCA/MMSE (Interventional Group)

EXPERIMENTAL

The training sessions mentioned in group MoCA/MMSE will be similarly provided in this group. Brain on Track is a web-based platform, used to remotely monitor cognitive function. There will be a first assessment with the aim of training eligible patients to correctly use Brain on Track, and a second assessment, one week after the first session. Depending on the score obtained in the second assessment, patients will be immediately referred to a specialized consultation, will not be referred or will be followed up during a period of 12 months with remote self monitorization, every three months. According to the total score from the four self-assessments performed in the follow-up period, PCCs will decide whether to refer or not. Patients who are illiterate will be evaluated through regular clinical practice, or MMSE or MoCA tests, according to years of schooling, if they are literate, but do not gather the inclusion criteria for the administration of Brain on Track.

Diagnostic Test: Mini Mental State Examination; Diagnostic Test: Montreal Cognitive Assessment; Device: Brain on Track (version BOT.0.0.0 03.03.2023)

Control Group

NO INTERVENTION

Regular clinical practice complemented with the provision of standardized criteria for referring patients with a suspected diagnosis of MCI or early dementia to PCCs.

Interventions

Mini Mental State Examination DIAGNOSTIC_TEST

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.

Also known as: MMSE

Group Brain on Track/MoCA/MMSE (Interventional Group); Group MoCA/MMSE (Interventional Group)

Montreal Cognitive Assessment DIAGNOSTIC_TEST

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.

Also known as: MoCA

Group Brain on Track/MoCA/MMSE (Interventional Group); Group MoCA/MMSE (Interventional Group)

Brain on Track (version BOT.0.0.0 03.03.2023) DEVICE

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.

Also known as: BOT

Group Brain on Track/MoCA/MMSE (Interventional Group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults who are native from Portugal and fluent in Portuguese, have not already been diagnosed with dementia, have no motor, visual and/or hearing limitations and present to PCCs with cognitive complaints

You may not qualify if:

• Motor, visual and hearing limitations

Sponsors & Collaborators

• Universidade do Porto: lead
• Unidade Local de Saúde de Matosinhos, EPE: collaborator
• Instituto de Saude Publica da Universidade do Porto: collaborator

Study Sites (1)

Instituto de Saúde Pública da Universidade do Porto

Porto, 4050-600, Portugal

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Dementia

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Luís Ruano, PhD

  Institute of Public Health of University of Porto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Magda Fonseca, PhDc

CONTACT

(+351) 968027910; up199903167@edu.med.up.pt

Janete Santos, PhD

CONTACT

(+351) 225 513 600; investigaclinica@med.up.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: The pilot study is single blinded in the perspective of the Neurology consultation, regarding the origin and method of referral of each patient with a suspected diagnosis of MCI or early dementia from primary care.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The unit of study is the FHU. The six FHU recruited will be randomly allocated to the three study groups and each FHU will belong to the same group during the total period of the study. The study will be conducted simultaneously in all groups.

Study Record Dates

• First Submitted: May 15, 2023
• First Posted: June 6, 2023
• Study Start: March 1, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: January 25, 2024

Record last verified: 2023-05

Locations

PT (1)