Case-Finding for Neurocognitive Disorders in Pavia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIRCCS National Neurological Institute "C. Mondino" Foundation
About this trial
Dementia is a global public health challenge with a heavy caregiving burden, impacting families, communities, and healthcare systems. It is a priority in healthcare planning, with focus on early diagnosis and ongoing support. This research project addresses the global public health challenge posed by dementia, focusing on early detection and comprehensive care. The research evaluates the clinical, social, and healthcare impact of two dementia-related projects in Italy:
1. the first "Ricor-Dare," aims to create an integrated network for identifying new cases of dementia or Mild Cognitive Impairment (MCI) and providing care to patients and caregivers; 2. the second involves establishing a new Center for Cognitive Disorders and Dementia (CCDD) in an area previously lacking such services.
The primary goal of this study is to assess the effectiveness of case-finding strategies promoted by the "Ricor-Dare" project for the early detection of cognitive decline. Researchers will compare three different settings in which case-finding will be conducted: at the general practitioners' offices, at the Dementia Operations Center, and at Open Days for the general population. The aim is to measure how many individuals in these three settings are diagnosed with Mild Cognitive Impairment (MCI) or dementia, compared to those identified as potential cases through cognitive testing.
The secondary goal of the study is to assess the social, care, and prevention impact of the activities offered within the two projects. This includes evaluating the experiences of patients and families who access the new CCDD in the province of Pavia, the impact of care pathways on caregivers, and comparing the effectiveness of the new CCDD with existing ones in the region of Lombardia. The study will also assess the role of the "Ricor-Dare" project in addressing the needs of patients, caregivers, and professionals, as well as the effectiveness of awareness-raising and training activities on dementia. Overall, the study aims to provide valuable insights into improving care for people with dementia and supporting their families and caregivers.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 50 or older
Assessment conducted using GPcog/ACE-III depending on the setting
No prior diagnosis of cognitive decline
Ability to understand the study objectives and sign an informed consent
Disqualifiers
Age under 50
Presence of a diagnosis of cognitive decline
Limited knowledge of the Italian language
All patients/people who are included in one of the actions provided through the "Ricor-Dare" Project or who are attending a visit scheduled in the clinical-care pathway of the CDCD Fondazione Mondino Pavia or Lomellina;
Trial design
Design model
Single group
Treatments tested in this trial
Case-finding for Neurocognitive Disorders
Other interventionThe intervention targets individuals reporting cognitive concerns without a prior diagnosis of MCI or dementia, with participants accessing three different settings for evaluation. The first setting involves General Practitioner (GP) offices, where GPs, trained in dementia risk factors and cognitive assessment tools (such as GPcog), will identify at-risk patients and refer them for further evaluation at a Center for Cognitive Disorders and Dementia (CCDD). The second setting is the Dementia Operations Center (COD) Information Desk, a public service where neuropsychologists assess citizens who independently report cognitive disturbances. The third setting includes Open Days, public events aimed at detecting early signs of cognitive decline, where neuropsychologists will assess participants using the Addenbrooke's Cognitive Examination-III (ACE-III) and the LIBRA Index. Individuals identified as at-risk in any of the three settings will be referred for further evaluation at a CCDD.
Treatment groups
490 Participants
are divided into 1 treatment groupGroup A: Detection of people reporting cognitive concernsOther 1 intervention
Trial outcomes
Primary outcomes
1
Effects of the case-finding strategy for the early detection of dementia in its prodromal or initial stages.
The number of individuals, from the three case-finding settings, diagnosed at the CCDD with Mild Cognitive Impairment (MCI) or dementia within 26 months following assessment at case-finding compared to the total number of people identified as positive cases through GPcog and/or ACE-III and assessed within the three different case-finding settings.
Time frame
Up to 26 monthsSecondary outcomes
1
The impact of the new CCDD on clinical care in an area that previously lacked such services.
Number of patients managed at the new CDCD during the study period, all of whom underwent a baseline neurological examination, a comprehensive neuropsychological assessment, and a follow-up neurological evaluation.
Time frame
Up to 26 months2
Patient and caregiver satisfaction with accessing the new CCDD.
Number of completed satisfaction questionnaires from both patients and caregivers and their satisfaction regarding waiting times for the first medical appointments, satisfaction with the initial consultation, fulfillment of needs, and quality of services provided. For each item minimum score is 1 and maximum score is 5, where a higher score indicates higher satisfaction.
Time frame
Up to 26 months3
The impact of the diagnostic-care pathway for caregivers at CCDD and "Ricor-Dare" project.
Number of caregivers who completed the initial and final assessments and received support interventions. The efficacy of these interventions is assessed by measuring changes in caregiver burden using the validated Zarit Burden Interview. The minimum score is 0 and the maximum score is 88, where a higher score indicates a greater caregiver burden.
Time frame
Up to 26 months4
The impact of the "Dementia Operations Center (COD)" pathway of the "Ricor-Dare" project.
Number of requests received and successfully addressed through the Dementia Operations Center (COD) pathway of the 'Ricor-Dare' project.
Time frame
Up to 26 monthsSponsors and contacts
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Source ClinicalTrials.gov