xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05966207</url>
    </required_header>
    <id_info>
      <org_study_id>FD3-2022</org_study_id>
      <nct_id>NCT05966207</nct_id>
    </id_info>
    <brief_title>Individual Intervention of Cognitive Stimulation</brief_title>
    <official_title>Making a Difference 3 - Individual Intervention of Cognitive Stimulation</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Escola Superior de Enfermagem de Coimbra</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Escola Superior de Enfermagem de Coimbra</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Population aging in Portugal has led to problematic social issues (American Psychiatric&#xD;
        Association, 2013; Spector, Woods &amp; Orrell, 2008; Wimo &amp; Prince, 2010). At the same time,&#xD;
        there is a noticeable increase in the prevalence of Neurocognitive Disorders (NCDs), commonly&#xD;
        referred to in clinical practice as mild cognitive impairment and dementia (Apóstolo,&#xD;
        Cardoso, Silva &amp; Costa, 2014; Apóstolo &amp; Cardoso, 2014).&#xD;
  &#xD;
        NCDs can be classified based on the degree of cognitive decline, ranging from mild to major,&#xD;
        and based on etiology, which includes Alzheimer's disease, Vascular dementia, Lewy body&#xD;
        dementia, Frontotemporal dementia, and others (American Psychiatric Association, 2013).&#xD;
  &#xD;
        In the European context, Portugal is among the minority of countries that do not have an&#xD;
        official strategy for the care of people with mild cognitive impairment and dementia.&#xD;
        Therefore, it is imperative to define national health policies that address the identified&#xD;
        needs (Knapp et al., 2006).&#xD;
  &#xD;
        Currently, non-pharmacological interventions, such as Individual Cognitive Stimulation (ICS),&#xD;
        are gaining relevance as treatment responses to the aforementioned syndromes, due to the&#xD;
        increasing clinical, social, and economic impact of mild cognitive impairment and dementia&#xD;
        (Aguirre, Hoare, Spector, Woods, &amp; Orrell, 2014; Apóstolo et al., 2014).&#xD;
  &#xD;
        ICS can be considered the implementation of a set of meaningful activities, carried out over&#xD;
        several sessions, usually in a social context, with the aim of stimulating various domains,&#xD;
        including attention, thinking, language, memory, and calculation (Aguirre et al., 2012;&#xD;
        Apóstolo et al., 2014; Yates, Orrell, Spector &amp; Orgeta, 2015).&#xD;
  &#xD;
        Current evidence supports the effectiveness of this intervention, indicating that ICS&#xD;
        programs are associated with health benefits, particularly in cognition, mood, well-being,&#xD;
        functional activity, quality of life, and communication skills (Apóstolo et al., 2014; Yates&#xD;
        et al., 2014).&#xD;
  &#xD;
        Providing care to people with mild cognitive impairment and dementia poses a challenge for&#xD;
        the healthcare system, necessitating the implementation of specific interventions to increase&#xD;
        self-care potential, autonomy, adaptation, and coping with deficits, as well as empowering&#xD;
        the family and/or support network (Alzheimer Europe, 2013; Orrell et al., 2012; Woods,&#xD;
        Aguirre, Spector &amp; Orrell, 2012; Yates et al., 2015). Due to the global pandemic context of&#xD;
        SARS-CoV-2, social care institutions for the elderly underwent changes in their dynamics. One&#xD;
        of the measures implemented during the emergency plan was the closure of adult day care&#xD;
        centers. The elderly who previously attended these social care facilities are now staying in&#xD;
        their own homes or with family/informal caregivers, thus being deprived of the social and&#xD;
        cognitive stimuli they were accustomed to.&#xD;
  &#xD;
        The mobilization of this population to their homes has led to increased social isolation and&#xD;
        loneliness, which are underestimated public health risks. These factors affect a significant&#xD;
        proportion of the elderly population and can lead to cognitive decline, feelings of&#xD;
        loneliness, sadness, and abandonment, which were previously alleviated by the social care&#xD;
        centers (National Academies of Sciences, Engineering, and Medicine, 2020).&#xD;
  &#xD;
        Given the described situation, the Making a Difference 3 program - an ICS program -&#xD;
        represents an excellent implementation option, as it can be developed in various contexts,&#xD;
        including the home environment, using cost-effective resources, addressing many of the needs&#xD;
        of both individuals with cognitive impairment and their informal family caregivers.&#xD;
  &#xD;
        In summary, in Portugal, there is no established practice of implementing structured ICS&#xD;
        interventions with individual sessions for use in the home environment. Thus, there is a need&#xD;
        for the MD3 program to be disseminated to promote best practices. In response to the needs&#xD;
        arising from the current pandemic context, the team of this project aims to produce national&#xD;
        evidence on the effect of ICS in individuals with mild cognitive impairment and dementia, in&#xD;
        the home environment of the elderly person, managed by informal caregivers and supervised by&#xD;
        healthcare professionals.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">December 27, 2021</start_date>
    <completion_date type="Actual">January 30, 2023</completion_date>
    <primary_completion_date type="Actual">January 30, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Cognition</measure>
      <time_frame>Assessed at baseline (week 0, pre-intervention) and week 13 (post-intervention)</time_frame>
      <description>Assessed using the Saint Louis University Mental Status Test (SLUMS), by Tarik et al. (2006)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Quality of Life</measure>
      <time_frame>Assessed at baseline (week 0, pre-intervention) and week 13 (post-intervention)</time_frame>
      <description>Assessed using the Quality of Life in Alzheimer's disease (QoL-AD) scale by Logsdon et al. (1999)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Dementia-related behavioral symptoms</measure>
      <time_frame>Assessed at baseline (week 0, pre-intervention) and week 13 (post-intervention)</time_frame>
      <description>Assessed using The Neuropsychiatric Inventory (NPI) by Cummings et al. (1994)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of the Carer-Patient Relantionship</measure>
      <time_frame>Assessed at baseline (week 0, pre-intervention) and week 13 (post-intervention)</time_frame>
      <description>Assessed using the Quality of the Carer-Patient Relationship (QCPR) scale by Spruytte et al. (2002), validated to the European Portuguese population by Silva et al. (2019)</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Actual">53</enrollment>
    <condition>Cognitive Dysfunction</condition>
    <arm_group>
      <arm_group_label>Individual Cognitive Stimulation</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The Individual Cognitive Stimulation (ICS) program to be implemented is called &quot;Making a Difference 3 - Individual Intervention of Cognitive Stimulation - A manual for caregivers&quot; (MD3). It was specifically designed to be applied in a home context, with informal/family caregivers taking charge of implementing the stimulation sessions (Apostolo, Silva, Costa &amp; Bobrowicz-Campos, 2019; Yates et al., 2015). The MD3 program has been translated and validated for the Portuguese culture and language (Silva, 2019).</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Individual Cognitive Stimulation</intervention_name>
      <description>The Individual Cognitive Stimulation will be conducted by caregivers, with support by the research team. The intervention will span 12 weeks, consisting of three weekly sessions (30 minutes each session), totaling 36 sessions. Caregivers in this study will utilize a previously translated and validated version of &quot;Making a Difference 3 - Individual Intervention of Cognitive Stimulation - A manual for caregivers,&quot; specifically adapted for the European Portuguese population.</description>
      <arm_group_label>Individual Cognitive Stimulation</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Older adults or near-elderly individuals (aged 60 years or above), diagnosed with mild&#xD;
               cognitive impairment or dementia by a neurology or psychiatry specialist, or validated&#xD;
               by a family physician based on DMS-III/IV/5 or ICD-9/10 criteria;&#xD;
  &#xD;
            -  Without significant physical illness or disability.&#xD;
  &#xD;
            -  Having an informal caregiver, whether a family member, friend, neighbor, or volunteer.&#xD;
  &#xD;
            -  Presence of mild to moderate cognitive impairment according to the 6-Item Cognitive&#xD;
               Impairment Test (6CIT), translated and adapted by Apóstolo and Paiva (2015).&#xD;
  &#xD;
            -  Individuals with mild cognitive impairment or dementia who are capable of&#xD;
               communication and understanding.&#xD;
  &#xD;
            -  Individuals residing in the community (at home).&#xD;
  &#xD;
            -  Having an available informal caregiver, whether a family member, friend, neighbor, or&#xD;
               volunteer, who is capable of implementing the individual cognitive stimulation&#xD;
               program.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Elderly individuals or informal caregivers with a history of serious psychiatric&#xD;
               illness diagnosed before the age of 60 are excluded from participation.&#xD;
  &#xD;
            -  Informal caregivers with any level of cognitive impairment, even mild (according to&#xD;
               DSM-5 criteria), are not eligible for inclusion.&#xD;
  &#xD;
            -  Elderly individuals residing in a social response facility, such as a nursing home or&#xD;
               elderly residence, are not considered for this study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>60 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>The Health Sciences Research Unit: Nursing</name>
        <address>
          <city>Coimbra</city>
          <zip>3004-011</zip>
          <country>Portugal</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Portugal</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 21, 2023</study_first_submitted>
    <study_first_submitted_qc>July 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 21, 2023</last_update_submitted>
    <last_update_submitted_qc>July 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Escola Superior de Enfermagem de Coimbra</investigator_affiliation>
      <investigator_full_name>Joao Apostolo</investigator_full_name>
      <investigator_title>PhD</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Cognitive Dysfunction</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
      <ipd_description>Individual participant data (IPD) will be made available upon reasonable request made to the principal investigator.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05966207
  org study id: FD3-2022
  nct id: NCT05966207
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Population aging in Portugal has led to problematic social issues (American Psychiatric
        Association, 2013; Spector, Woods & Orrell, 2008; Wimo & Prince, 2010). At the same time,
        there is a noticeable increase in the prevalence of Neurocognitive Disorders (NCDs), commonly
        referred to in clinical practice as mild cognitive impairment and dementia (Apóstolo,
        Cardoso, Silva & Costa, 2014; Apóstolo & Cardoso, 2014).
  
        NCDs can be classified based on the degree of cognitive decline, ranging from mild to major,
        and based on etiology, which includes Alzheimer's disease, Vascular dementia, Lewy body
        dementia, Frontotemporal dementia, and others (American Psychiatric Association, 2013).
  
        In the European context, Portugal is among the minority of countries that do not have an
        official strategy for the care of people with mild cognitive impairment and dementia.
        Therefore, it is imperative to define national health policies that address the identified
        needs (Knapp et al., 2006).
  
        Currently, non-pharmacological interventions, such as Individual Cognitive Stimulation (ICS),
        are gaining relevance as treatment responses to the aforementioned syndromes, due to the
        increasing clinical, social, and economic impact of mild cognitive impairment and dementia
        (Aguirre, Hoare, Spector, Woods, & Orrell, 2014; Apóstolo et al., 2014).
  
        ICS can be considered the implementation of a set of meaningful activities, carried out over
        several sessions, usually in a social context, with the aim of stimulating various domains,
        including attention, thinking, language, memory, and calculation (Aguirre et al., 2012;
        Apóstolo et al., 2014; Yates, Orrell, Spector & Orgeta, 2015).
  
        Current evidence supports the effectiveness of this intervention, indicating that ICS
        programs are associated with health benefits, particularly in cognition, mood, well-being,
        functional activity, quality of life, and communication skills (Apóstolo et al., 2014; Yates
        et al., 2014).
  
        Providing care to people with mild cognitive impairment and dementia poses a challenge for
        the healthcare system, necessitating the implementation of specific interventions to increase
        self-care potential, autonomy, adaptation, and coping with deficits, as well as empowering
        the family and/or support network (Alzheimer Europe, 2013; Orrell et al., 2012; Woods,
        Aguirre, Spector & Orrell, 2012; Yates et al., 2015). Due to the global pandemic context of
        SARS-CoV-2, social care institutions for the elderly underwent changes in their dynamics. One
        of the measures implemented during the emergency plan was the closure of adult day care
        centers. The elderly who previously attended these social care facilities are now staying in
        their own homes or with family/informal caregivers, thus being deprived of the social and
        cognitive stimuli they were accustomed to.
  
        The mobilization of this population to their homes has led to increased social isolation and
        loneliness, which are underestimated public health risks. These factors affect a significant
        proportion of the elderly population and can lead to cognitive decline, feelings of
        loneliness, sadness, and abandonment, which were previously alleviated by the social care
        centers (National Academies of Sciences, Engineering, and Medicine, 2020).
  
        Given the described situation, the Making a Difference 3 program - an ICS program -
        represents an excellent implementation option, as it can be developed in various contexts,
        including the home environment, using cost-effective resources, addressing many of the needs
        of both individuals with cognitive impairment and their informal family caregivers.
  
        In summary, in Portugal, there is no established practice of implementing structured ICS
        interventions with individual sessions for use in the home environment. Thus, there is a need
        for the MD3 program to be disseminated to promote best practices. In response to the needs
        arising from the current pandemic context, the team of this project aims to produce national
        evidence on the effect of ICS in individuals with mild cognitive impairment and dementia, in
        the home environment of the elderly person, managed by informal caregivers and supervised by
        healthcare professionals.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Cognition
  time frame: Assessed at baseline (week 0, pre-intervention) and week 13 (post-intervention)
  description: Assessed using the Saint Louis University Mental Status Test (SLUMS), by Tarik et al. (2006)
  measure: Quality of Life
  time frame: Assessed at baseline (week 0, pre-intervention) and week 13 (post-intervention)
  description: Assessed using the Quality of Life in Alzheimer's disease (QoL-AD) scale by Logsdon et al. (1999)
  measure: Dementia-related behavioral symptoms
  time frame: Assessed at baseline (week 0, pre-intervention) and week 13 (post-intervention)
  description: Assessed using The Neuropsychiatric Inventory (NPI) by Cummings et al. (1994)
  measure: Quality of the Carer-Patient Relantionship
  time frame: Assessed at baseline (week 0, pre-intervention) and week 13 (post-intervention)
  description: Assessed using the Quality of the Carer-Patient Relationship (QCPR) scale by Spruytte et al. (2002), validated to the European Portuguese population by Silva et al. (2019)
  arm group label: Individual Cognitive Stimulation
  arm group type: Experimental
  description: The Individual Cognitive Stimulation (ICS) program to be implemented is called "Making a Difference 3 - Individual Intervention of Cognitive Stimulation - A manual for caregivers" (MD3). It was specifically designed to be applied in a home context, with informal/family caregivers taking charge of implementing the stimulation sessions (Apostolo, Silva, Costa & Bobrowicz-Campos, 2019; Yates et al., 2015). The MD3 program has been translated and validated for the Portuguese culture and language (Silva, 2019).
  intervention type: Behavioral
  intervention name: Individual Cognitive Stimulation
  description: The Individual Cognitive Stimulation will be conducted by caregivers, with support by the research team. The intervention will span 12 weeks, consisting of three weekly sessions (30 minutes each session), totaling 36 sessions. Caregivers in this study will utilize a previously translated and validated version of "Making a Difference 3 - Individual Intervention of Cognitive Stimulation - A manual for caregivers," specifically adapted for the European Portuguese population.
  arm group label: Individual Cognitive Stimulation
  criteria: 
  gender: All
  minimum age: 60 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  country: Portugal
  responsible party type: Principal Investigator
  investigator affiliation: Escola Superior de Enfermagem de Coimbra
  investigator full name: Joao Apostolo
  investigator title: PhD
  mesh term: Cognitive Dysfunction
  sharing ipd: Undecided
  ipd description: Individual participant data (IPD) will be made available upon reasonable request made to the principal investigator.