Clinical trial NCT06983119: Case-Finding for Neurocognitive Disorders in Pavia
Official title: OPENING OF A MEMORY CLINIC IN THE PROVINCE OF PAVIA: Evaluation of Case-finding Strategies and Care for People With Cognitive Decline and Their Caregivers.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Dementia
Mild Cognitive Impairment
Keywords: Case-finding
Dementia
Mild Cognitive Impairment
Memory Clinic
Center for Cognitive Disorders and Dementia
Non-pharmacological intervention
Caregiver
Burden
Lead sponsor: IRCCS National Neurological Institute "C. Mondino" Foundation
Sponsor class: OTHER
First posted: 2025-05-21
Enrollment: 490
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed description: Dementia is currently one of the most urgent challenges that global public health must address, with a significant caregiving burden that deeply impacts families, communities, and healthcare systems. It is a key priority in healthcare and social care planning worldwide, with growing emphasis on early diagnosis and appropriate support throughout the course of the disease. According to the World Health Organization, more than 55 million people globally have been diagnosed with dementia, and this number is expected to rise to 139 million by 2050. In Italy, approximately one million people are affected by dementia, and around 900,000 have MCI, with more than three million people directly or indirectly involved in caregiving. However, in high-income countries, the proportion of diagnosed cases remains relatively low, with estimates suggesting that only 20-50% of documented cases are diagnosed in primary care settings. The province of Pavia has 539,239 inhabitants, with an estimated 11,300 individuals diagnosed with dementia and 9,000 with MCI. Consistent with international literature, the ratio of observed to expected cases of dementia and MCI suggests a significant underestimation. Timely diagnosis of the disease or risk of disease enables the person and their caregivers to make informed choices, plan for the future, and gain access to treatments that can help manage symptoms. Centers for Cognitive Disorders and Dementia (CCDD) are healthcare services that play a critical role in the management of dementia and cognitive disorders. Scientific evidence shows that timely access to a specialized cognitive assessment and diagnostic service can lead to better outcomes for individuals with cognitive decline and their families, and be cost-effective for the healthcare system. An accurate and timely diagnosis, support for individuals with dementia and their families, along with early intervention by a multidisciplinary team of healthcare professionals, can have a positive impact on maintaining functional abilities and delaying cognitive decline and institutionalization.

The overall goal of this study is to assess the social and health impact of various services and actions aimed at individuals with cognitive decline within two projects initiated in Italy, specifically in in the Pavia area located in northern Italy: the "Ricor-Dare: integrated territorial network for dementia" project and the opening of a new Cognitive Disorders and Dementia Center (CCDD) Lomellina by Fondazione Mondino in the city of Vigevano. Specifically, the primary goal of this study is to measure the effects of case-finding strategies for the timely detection of dementia in its prodromal or early stages across three different settings. The secondary aim of this study is to evaluate and monitor the social and care effects of the activities offered within the two projects, aimed at patients, caregivers, healthcare professionals, and the community, through a series of indicators reflecting social and health care. This objective will allow for the evaluation, through a set of indicators, of the impact of these complex social and health care, and social actions both on patients identified through case-finding activities and on patients attending the new CCDD Lomellina in the province of Pavia.

For the primary goal of this study, the investigators will evaluate the impact of different case-finding strategies in identifying patients with MCI or dementia. These strategies will be implemented across three different settings:

1. General Practitioners (GPs) Offices: With their in-depth knowledge of their patients' medical histories, GPs play a crucial role in identifying those at risk of dementia or exhibiting cognitive symptoms. Using tools like the GP Cognitive Assessment of Cognition (GPcog), GPs can detect early signs of cognitive decline and refer patients for further evaluation at a CCDD. As part of the study, two annual conferences will be organized to train GPs on neurodegenerative diseases, dementia risk factors, and the GPcog. Patients scoring at the GPcog below 5 or in the borderline range (5-8) will be referred for a second-level neuropsychological evaluation at the CCDD. Additionally, a neuropsychologist will visit selected GP offices three times a year. During these visits, the neuropsychologist will conduct interviews, assess risk factors using the Lifestyle for BRAin health (LIBRA), and perform cognitive evaluations using the Addenbrooke's Cognitive Examination-III (ACE-III). Patients with below-normal or borderline ACE-III scores will be recommended for further CCDD evaluation. This initiative aims to enhance GPs' awareness of case-finding tools in their routine practice.
2. Information desk of the Dementia Operations Center (COD): The COD information desk offers a free public service aimed at the early management of citizens reporting subjective cognitive disturbances that may indicate prodromal or early-stage dementia. The case-finding strategy at the COD involves enrolling all citizens who independently report subjective cognitive disturbances without a prior diagnosis of cognitive decline. Specifically, a neuropsychologist will conduct an interview to collect demographic and medical history information, as well as dementia risk factors through the LIBRA Index, and carry out a first-level neuropsychological assessment through the ACE-III. Those scoring below the norm or borderline will be recommended for further evaluation at the CCDD.
3. Open Days: The Open Days are territorial initiatives for citizen designed for the early management of reports regarding subjective cognitive disturbances that could indicate prodromal or early-stage dementia. The case-finding strategy for Open Days involves organizing approximately two events per year, aimed at early detection of cognitive disturbances. During the Open Day, a neuropsychologist will conduct an interview to collect demographic and medical history information, as well as risk factors for dementia through the LIBRA Index, and perform a first-level neuropsychological assessment through the ACE-III. Those scoring below the norm or borderline will be recommended for further evaluation at the CCDD.

For the secondary goal of the study, the investigators will assess 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. Below a detailed description of the six secondary outcomes are presented:

1. Explore the effect of the opening of a new CCDD. Assessing the role and contribution of the new CCDD in the management and care of individuals with dementia and MCI comparing data with other CCDDs in the Lombardy region. At the new CCDD, various diagnostic and care services are offered for patients with cognitive impairment. These include a neurological consultation to assess cognitive deterioration, followed by additional tests such as neuropsychological evaluations, neuroimaging, and advanced diagnostics at the Mondino Foundation. Multidisciplinary consultations, such as geriatrics and psychiatry, may also be recommended based on the neurologist's discretion. After the diagnostic process, patients and their families receive a joint consultation with a neurologist and psychologist to discuss the diagnosis and define a care plan. This care plan encompasses pharmacological treatments, including regular follow-ups for adjusting medications, and non-pharmacological treatments, such as individual or group cognitive stimulation. To evaluate the impact of the new CCDD's activity, data will be collected on the number of patients assessed, their diagnoses, and the services provided. An online questionnaire based on the National Survey on Cognitive Disorders and Dementia Centers will be administered to the CCDD Mondino Lomellina and Mondino Pavia to gather this data. The responses will be compared with previous survey results and regional benchmarks.
2. Explore the experience of people with cognitive decline and their caregivers accessing the new CCDD to evaluate the social and healthcare impact of opening a new CCDD. This will provide insights into challenges and needs, helping improve support throughout the diagnostic and care process. To achieve this, two methods will be employed. The first involves administering tailored questionnaires to both patients with mild dementia or MCI and their caregivers after their first follow-up visit at the CCDD. The second method includes conducting an online focus group with at least 10 caregivers, providing an opportunity to discuss their experiences with the new clinical care setup.
3. Evaluate the impact and effectiveness of diagnostic and care pathways specifically designed for caregivers, offered in the "Ricor-Dare" project and through routine clinical practice at the new CCDD. This action involves three phases: an initial evaluation (pre-test) of caregivers' burden (Zarit Burden Interview) and caregivers' preparedness to assess their perceived readiness to manage the physical and emotional needs of their loved ones (Caregiver Preparedness Scale), followed by tailored support interventions (individual psychological support, psychoeducational groups, Alzheimer's café), and a final evaluation (post-test) with the same questionnaires use in the pre-test session to assess the effectiveness of the interventions.
4. Evaluate the social and healthcare impact of the "Dementia Operations Center (COD)" as a resource for people with dementia, caregivers, and healthcare and social-care professionals. The Dementia Operations Center (COD) is the central hub of the "Ricor-Dare" project. It serves as a key point of contact for dementia-related inquiries, facilitating early intervention by directing patients, caregivers, and healthcare professionals to the appropriate services within the territorial network. The COD receives referrals from healthcare providers such as general practitioners (GPs), hospitals, nursing homes, social services, and directly from patients, caregivers, or citizens. The initial contact is made via phone, and based on an analysis of the caller's needs, further physical consultations may be recommended at the COD's information desk. With a thorough mapping of the local healthcare and social service network, COD aims to meet the needs of patients, caregivers, and professionals by providing guidance on the best path for cognitive decline management. This includes assistance with the recommended pathway, non-pharmacological treatments, and caregiver support. The COD also provides information on local healthcare services, such as CCDD, nursing homes, home care, social services, and legal processes like disability procedures. The first contact with COD is through a phone number, answered by trained psychologists or staff. If necessary, callers are referred to the physical COD desk for further evaluation.
5. Evaluate the impact of awareness and education activities on dementia. The goal is to promote social and cultural actions that improve inclusivity for people with dementia within the community. Awareness initiatives will be delivered through three annual events targeting citizens, third-sector personnel (e.g., police, firefighters), and middle and high school students.
6. Evaluate the effectiveness of training activities for healthcare and social care professionals. The objective is to assess the effectiveness of these training programs in enhancing professionals' understanding of dementia and their attitudes toward patients and caregivers. The training, provided within the Cariplo "Welfare in Aging" project - "Ricor-Dare: Integrated Territorial Dementia Network," includes annual sessions led by experts, tailored to different roles (e.g., GPs, pharmacists, nurses, healthcare assistants). To measure the training's effectiveness, participants will complete the Dementia Knowledge-20 (DK-20) and the Approaches to Dementia Questionnaire (ADQ) before (T0) and after (T1) the training. Additionally, a survey will assess the perceived utility and relevance of the training content in clinical practice.

Eligibility criteria: For the Primary Outcome the inclusion criteria are:

* 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

For the Primary Outcome the exclusion criteria are:

* Age under 50
* Presence of a diagnosis of cognitive decline
* Limited knowledge of the Italian language

For the secondary outcome the inclusion criteria are:

Patient:

* 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;
* Ability to understand the aims of the study and to sign an informed consent

Caregiver:

* Age equal to or greater than 18 years
* Informal caregiver of a family member with a suspected or confirmed diagnosis of dementia who is 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;
* Acceptance of informed consent and voluntary participation in the study.

Healthcare professionals:

* All healthcare and social healthcare professionals (GPs, pharmacists, nurses, nurses auxiliary) who practice in the cities of Pavia and Vigevano who participate in the project and agree to undergo assessments and training;
* Acceptance of informed consent and voluntary participation in the study.

Fo the Secondary Outcome the exclusion criteria are:

Patient:

- Inability to understand the aims of the study and to sign an informed consent

Caregiver:

* Age under 18
* Formal caregivers, i.e. any person who provides assistance to the patient in exchange for payment of a fee;
* Caregivers with limited knowledge of the Italian language.

Primary outcomes:
measure: Effects of the case-finding strategy for the early detection of dementia in its prodromal or initial stages.
timeFrame: Up to 26 months
Secondary outcomes:
measure: The impact of the new CCDD on clinical care in an area that previously lacked such services.
timeFrame: Up to 26 months
measure: Patient and caregiver satisfaction with accessing the new CCDD.
timeFrame: Up to 26 months
measure: The impact of the diagnostic-care pathway for caregivers at CCDD and "Ricor-Dare" project.
timeFrame: Up to 26 months
measure: The impact of the "Dementia Operations Center (COD)" pathway of the "Ricor-Dare" project.
timeFrame: Up to 26 months
measure: The impact of education activities on dementia promoted by the "Ricor-Dare" project.
timeFrame: Up to 26 months
measure: Effectiveness of training activities for healthcare and social care professionals promoted by the "Ricor-Dare" project.
timeFrame: Up to 26 months
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: IRCCS National Neurological Institute "C. Mondino" Foundation
Study officials:
affiliation: IRCCS National Neurological Institute "C. Mondino" Foundation
name: Alfredo Costa, MD
role: STUDY_DIRECTOR
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