<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/NCT04443621</url>
  </required_header>
  <id_info>
    <org_study_id>NU20-07-00100</org_study_id>
    <nct_id>NCT04443621</nct_id>
  </id_info>
  <brief_title>Changes in the Perception of Personal Dignity Over the Course of Dementia</brief_title>
  <acronym>DIDEM</acronym>
  <official_title>Changes in the Perception of Personal Dignity Over the Course of Dementia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Palacky University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University Hospital Hradec Kralove</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Faculty Hospital Kralovske Vinohrady</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital Olomouc</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University Hospital Ostrava</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Palacky University</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>
      Dignity is an integral part of quality of life (QoL). Older adults often face with situations&#xD;
      that are related with the development of dementia and that might significantly affect their&#xD;
      feeling of personal dignity. The aim of the project is to investigate the changes in the&#xD;
      perception of personal dignity amongst older adults with dementia (OAwD) over the course of&#xD;
      three years and to define factors that threaten their dignity. A mixed methods design&#xD;
      (longitudinal prospective study) will be used. In the quantitative part, a battery of Czech&#xD;
      questionnaires will be used, and a translation and validation of a Czech version of the&#xD;
      ACE-III will be carried out. The qualitative part will include in-depth interviews (narrative&#xD;
      and semi-structured). The sample will comprise of OAwD living in home setting. Knowledge of&#xD;
      the changes in the perception of personal dignity and related factors may aid the healthcare&#xD;
      staff in choosing interventions that support and preserve dignity of OAwD as a significant&#xD;
      part of their QoL. The project is a follow-up of a previous project No. 16-28628A.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A. Introduction to project, current state of art As the population ages, an increasing number&#xD;
      of people will be diagnosed with dementia. At present, there are some 47 million people&#xD;
      living with dementia worldwide. In Czech Republic, there are about 156,000 people suffering&#xD;
      from dementia. Regional estimates of dementia prevalence in people aged 60 years and over now&#xD;
      range from 4.6% in Central Europe to 8.7% in North Africa and the Middle East. It is&#xD;
      estimated up to 131 million people with dementia will live in the world by 2050. Thus, there&#xD;
      is a need of sensitive and specific cognitive assessment tools to detect cognitive&#xD;
      impairment. It enables to provide timely intervention to delay the disease progression,&#xD;
      prolong independence, and enhance the quality of life (QoL) and personal dignity of the&#xD;
      individual with dementia.&#xD;
&#xD;
      Dementia is neurodegenerative disease characterized by progressive, irreversible and still&#xD;
      incurable cognitive decline. People suffering from dementia retain their positive personality&#xD;
      traits and character. However, as the illness progresses, symptoms such as memory loss,&#xD;
      speech impairment, disorientation, difficulties with activities of daily living, and&#xD;
      self-neglect are common. This leads to a significant interference with everyday social and&#xD;
      work activities and has a negative impact on subjective perception of dignity. At present,&#xD;
      the Mini Mental State Examination (MMSE) is used in the Czech Republic to diagnose dementia.&#xD;
      Due to copyright issues with the MMSE (similar to the Montreal Cognitive Assessment [MoCA]&#xD;
      questionnaire), there is a need for another valid tool to be free available in the country.&#xD;
      Currently, the most frequently used tool in the world is the Addenbrooke's Cognitive&#xD;
      Examination III (ACE-III), which is composed of five domains: orientation and attention;&#xD;
      memory; fluency; language, and visuospatial function. The ACE-III-J is a sensitive and&#xD;
      specific screening test to diagnose dementia, and it was better than the MMSE in accuracy for&#xD;
      identifying dementia.&#xD;
&#xD;
      Dignity is described as an integral part of QoL. Similarly to QoL, dignity can also be&#xD;
      understood as a multidimensional concept including: dignity of identity&#xD;
      (self-worth/worthiness, integrity, trust); dignity as a human right (equality, freedom of&#xD;
      choice); and dignity as expression of autonomy (independence, control. There are three main&#xD;
      dimensions essential for constituting dignity: A historical dignity-dimension, acknowledging&#xD;
      one's own life projects and history; an intrapersonal dignity-dimension, recognizing one's&#xD;
      own human worth, and living according to individual values; and an interpersonal&#xD;
      dignity-dimension, experiencing being part of a caring and confirming society.&#xD;
&#xD;
      Jacobson (2007) says that dignity exists in two complementary, yet disparate forms. It is&#xD;
      understood as a dualistic concept incorporating absolute and relative dignity, objective and&#xD;
      subjective dignity, and personal and social dignity. Personal dignity is a type of dignity&#xD;
      that is subjectively perceived by an individual and is linked to a sense of worthiness.&#xD;
      However, personal dignity is also contingent and contextual, and can be influenced both by an&#xD;
      internal aspect, which is the worth and self-respect one ascribes to oneself, as well as by&#xD;
      an external aspect, which is the worth and value ascribed to the individual by others.&#xD;
&#xD;
      Patients with a severe chronic disease (such as neurodegenerative) experience existential&#xD;
      concerns related to changes in the self because of the disease, as well as the social&#xD;
      consequences of the disease (e.g. embarrassment, role changes, loss of independence, and&#xD;
      stigmatization), which can severely affect the sense of personal dignity.&#xD;
&#xD;
      Older adults with dementia (OAwD) are often experiencing an ongoing loss of personal dignity,&#xD;
      value and security, and experiencing cognitive decline can be a threat towards self-respect&#xD;
      and the sense of dignity. The key element of the dementia experience is the effort to&#xD;
      preserve one's identity or sense of self and to preserve a meaningful life. Multiple personal&#xD;
      losses and changes such as increased dependency, loss of autonomy and gradual loss of&#xD;
      abilities or competencies can have a negative impact on the sense of self and the self-esteem&#xD;
      of dementia sufferers. Thus, OAwD are in risk of personal dignity loss due to both impact of&#xD;
      the disease on their identity and self-esteem, and indirectly through negative social&#xD;
      interactions and experiences. Before entering the stage of severe dementia individuals are&#xD;
      aware of the progressive decline in their abilities and actively try to cope with this&#xD;
      decline. A sound sense of personal dignity is essential to the individual's overall&#xD;
      experience of well-being and his/her QoL. Investigation of the factors that maintain and&#xD;
      strengthen personal dignity needs to incorporate data collected from those afflicted.&#xD;
      However, research how having dementia may impact personal dignity into person's subjective&#xD;
      experience of mild to moderate dementia is only very recent.&#xD;
&#xD;
      Pilot data The proposed grant project builds on results of a previous project Trajectories of&#xD;
      quality of life by the elderly in in early-stage dementia (No. 16-28628A). The findings of&#xD;
      the project confirm that OAwD assess their QoL better when they have a greater sense of&#xD;
      personal dignity. The validated Czech version of Patient Dignity Inventory (PDI-CZ) created&#xD;
      and tested in our project No. 16-28628A will be used in the proposed project.&#xD;
&#xD;
      B. Project objectives, project timeline and description of methods and approaches To define&#xD;
      the factors that pose a threat to personal dignity gives an opportunity for a deeper&#xD;
      understanding of these issues. This can subsequently assist healthcare staff with choosing&#xD;
      the optimum interventions supporting QoL amongst OAwD. The proposed project responds to a&#xD;
      society-wide need to identify and solve psychosocial needs of an ageing population with&#xD;
      emphasis on neurodegenerative diseases.&#xD;
&#xD;
      The objective of the project is to investigate the changes in the perception of personal&#xD;
      dignity of OAwD. The opportunity to define risk factors threatening personal dignity over the&#xD;
      course of dementia will contribute to a deeper understanding of patients' needs. This will&#xD;
      help healthcare workers choose the optimum psychosocial interventions in accordance with&#xD;
      Evidence Based Practice and thus protect dignity of OAwD as a major component of QoL. This&#xD;
      may have a positive effect on the psycho-social dimension of QoL amongst OAwD and may lower&#xD;
      the frequency and length of hospitalizations as well as save costs on healthcare and social&#xD;
      services.&#xD;
&#xD;
      The main aim is to ascertain how the subjective perception of personal dignity in OAwD&#xD;
      changes throughout the course of this disease (trajectory of personal dignity perception) and&#xD;
      which factors affect it. Because different types of dementia might have different perceptions&#xD;
      of personal dignity related to specific disturbances of cognitive domains, post-hoc subgroup&#xD;
      analysis in different forms of dementia will be performed. For the assessment of cognition&#xD;
      and diagnosis of dementia, the Addenbrooke's Cognitive Examination III (ACE-III), POBAV, and&#xD;
      ALBA questionnaires will be used. For this reason, we need to create and validate a Czech&#xD;
      version of the ACE-III as the first stage of the project.&#xD;
&#xD;
      In order to achieve the main aim, five sub-aims were identified which should make it possible&#xD;
      to ascertain subjective perception of personal dignity and factors which affect in amongst&#xD;
      OAwD:&#xD;
&#xD;
        1. to create a Czech version of the ACE-III and to conduct a psychometric validation;&#xD;
&#xD;
        2. to ascertain how the assessment of personal dignity changes over the course of 2 years;&#xD;
&#xD;
        3. to identify sociodemographic and clinical factors perceived as a threat to dignity;&#xD;
&#xD;
        4. post-hoc subgroup analysis of results among the different types of dementia;&#xD;
&#xD;
        5. to define the differences in the perception of personal dignity among OAwD when using&#xD;
           quantitative (PDI-CZ) and qualitative (in-depth interview) methods.&#xD;
&#xD;
      C. Methodology In order to reach the set aims, a mixed methods research design (quantitative&#xD;
      survey first follow by qualitative interview) will be used to carry out a longitudinal,&#xD;
      prospective study.&#xD;
&#xD;
      In the quantitative phase of the project using a battery of standardized questionnaires (3&#xD;
      stages). Research nurse gave QAwD the questionnaires and explained how to complete them. The&#xD;
      questionnaires will be completed on project enrolment and then two more times at a 12-month&#xD;
      interval.&#xD;
&#xD;
      In the qualitative phase of the research, individual in-depth interviews with OAwD on the&#xD;
      topic of dignity (two interviews with each respondent at a 12-month interval) will be&#xD;
      conducted, recorded, and transcribed with a subsequent interpretative phenomenological&#xD;
      analysis. Two psychologists will be undertaking the interviews, in order to ensure that the&#xD;
      interviews are conducted in the most sensitive manner. Informed consent will be secured&#xD;
      before each interview. This will be carried out throughout project lifetime.&#xD;
&#xD;
      Questionnaire battery will be included: Addenbrooke's Cognitive Examination III (ACE-III),&#xD;
      Amnesia Light and Brief Assessment (ALBA), POBAV, Patient Dignity Inventory (PDI-CZ), Bristol&#xD;
      Activities of Daily Living Scale (BADLS-CZ), Geriatric Depression Scale (GDS), and a batch of&#xD;
      socio-demographic and clinical characteristics (including age, sex, level of education,&#xD;
      living arrangement, social life, frequency of social visits, telephone contact with&#xD;
      relatives/friends, and the daytime spent alone, illnesses, medication, etc).&#xD;
&#xD;
      Sample The sample will consist of community-dwelling (i.e., living at home) older adults.&#xD;
      They will be addressed together with their family caregivers in neurologic and geriatric&#xD;
      outpatient offices.&#xD;
&#xD;
      Sample size:&#xD;
&#xD;
      First sample (quantitative research) will comprise of 500 respondents (310 OAwD for the&#xD;
      longitudinal, three-stage study and 190 older adults for the validation study ACE-III).&#xD;
&#xD;
      Second sample (qualitative research) - after evaluating the 1st stage of the quantitative&#xD;
      research, we will select 10 OAwD from the sample group with high level (average scale more&#xD;
      than 3) and 10 OAwD who have low level of dignity to understand the different perspectives of&#xD;
      perception of personal dignity. The exact number of respondents will depend on the thematic&#xD;
      saturation in the course of interviewing.&#xD;
&#xD;
      Data from the quantitative research (validation study, and longitudinal study) will be&#xD;
      gathered using a questionnaire from 310 OAwD (longitudinal study) and 190 older adults (half&#xD;
      with dementia and half without dementia; validation study ACE-III) in neurologic and&#xD;
      geriatric outpatients' departments in four regions of the Czech Republic. All data will be&#xD;
      inserted into CASTOR database, from which they will be exported for statistical processing.&#xD;
&#xD;
      Data from the qualitative phase will be gathered using in-depth interviews with 20 OAwD.&#xD;
      These respondents we will select after evaluation the 1st stage of the quantitative research&#xD;
      (10 OAwD with high and 10 OAwD with low levels of dignity to understand the different&#xD;
      perspectives in perception of personal dignity). An interpretative phenomenological analysis&#xD;
      (IPA) will be applied. The IPA is an approach of a qualitative research, which is used to&#xD;
      examine how people make sense of their major life experiences. The method is often used to&#xD;
      study patients' lived experience. The data will be coded in NVivo 12 software for analysis.&#xD;
      To assure reliability of the analysis, two researchers will code the interviews independently&#xD;
      and they will confront their results for similarities and differences.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Anticipated">June 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Addenbrooke's Cognitive Examination III (ACE-III)</measure>
    <time_frame>12 months</time_frame>
    <description>To create a Czech version of the ACE-III and to conduct a psychometric validation</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient Dignity Inventory (PDI)</measure>
    <time_frame>24 months</time_frame>
    <description>To ascertain how the assessment of personal dignity changes over the course of two years</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Factors affecting dignity</measure>
    <time_frame>24 months</time_frame>
    <description>To identify sociodemographic and clinical factors perceived as a threat to dignity (including age, sex, level of education, living arrangement, social life, frequency of social visits, telephone contact with relatives/friends, and the daytime spent alone, illnesses, depression, self-sufficiency etc).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Differences in the perception of personal dignity</measure>
    <time_frame>24 months</time_frame>
    <description>To define the differences in the perception of personal dignity among OAwD when using quantitative (PDI-CZ) and qualitative (in-depth interview) methods.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Dignity among the different types of dementia</measure>
    <time_frame>24 months</time_frame>
    <description>Post-hoc subgroup analysis of results among the different types of dementia</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Dementia</condition>
  <condition>Dignity</condition>
  <arm_group>
    <arm_group_label>participants with early stage dementia</arm_group_label>
    <description>Subjects with diagnosed any type of dementia at an early phase (MMSE score 20 - 25 points) - for longitudinal study (three phasis).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>participants without dementia</arm_group_label>
    <description>Subjects without dementia with MMSE score 26 - 30 points (for validation of ACE-III).</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>questionnaire</intervention_name>
    <description>Questionnaire battery for assessment of dignity, cognition, self-sufficiency, and depression.</description>
    <arm_group_label>participants with early stage dementia</arm_group_label>
    <arm_group_label>participants without dementia</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>in-depth interview</intervention_name>
    <description>Individual in-depth interviews with OAwD on the topic of dignity (two interviews with each respondent at a 12-month interval) .</description>
    <arm_group_label>participants with early stage dementia</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Older adults aged ≥60 years.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Group I.: age ≥60 years; lives at home; diagnosed with dementia (MMSE score 20 - 25&#xD;
             points), ability to consent to participate in the research; in contact with a family&#xD;
             caregiver at least once a week.&#xD;
&#xD;
          -  Group II: age ≥60 years; lives at home; MMSE score 26 - 30 points, ability to consent&#xD;
             to participate in the research.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  for both groups: severe psychotic disorder; severe cognitive impairment (severe&#xD;
             hearing, visual or speech impairment), and terminal stage of caner or non-cancer&#xD;
             disease.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Helena Kisvetrova, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Faculty of Health Sciences Palacky University Olomouc</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital Hradec Kralove</name>
      <address>
        <city>Hradec Králové</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Palacky University</name>
      <address>
        <city>Olomouc</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Olomouc</name>
      <address>
        <city>Olomouc</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Ostrava</name>
      <address>
        <city>Ostrava</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Faculty Hospital Kralovske Vinohrady</name>
      <address>
        <city>Praha</city>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Czechia</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>June 19, 2020</study_first_submitted>
  <study_first_submitted_qc>June 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>September 24, 2020</last_update_submitted>
  <last_update_submitted_qc>September 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Palacky University</investigator_affiliation>
    <investigator_full_name>Helena Kisvetrova</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>dignity</keyword>
  <keyword>dementia</keyword>
  <keyword>older adult</keyword>
  <keyword>perception</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dementia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04443621
org study id: NU20-07-00100
nct id: NCT04443621
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Dignity is an integral part of quality of life (QoL). Older adults often face with situations
      that are related with the development of dementia and that might significantly affect their
      feeling of personal dignity. The aim of the project is to investigate the changes in the
      perception of personal dignity amongst older adults with dementia (OAwD) over the course of
      three years and to define factors that threaten their dignity. A mixed methods design
      (longitudinal prospective study) will be used. In the quantitative part, a battery of Czech
      questionnaires will be used, and a translation and validation of a Czech version of the
      ACE-III will be carried out. The qualitative part will include in-depth interviews (narrative
      and semi-structured). The sample will comprise of OAwD living in home setting. Knowledge of
      the changes in the perception of personal dignity and related factors may aid the healthcare
      staff in choosing interventions that support and preserve dignity of OAwD as a significant
      part of their QoL. The project is a follow-up of a previous project No. 16-28628A.
A. Introduction to project, current state of art As the population ages, an increasing number
      of people will be diagnosed with dementia. At present, there are some 47 million people
      living with dementia worldwide. In Czech Republic, there are about 156,000 people suffering
      from dementia. Regional estimates of dementia prevalence in people aged 60 years and over now
      range from 4.6% in Central Europe to 8.7% in North Africa and the Middle East. It is
      estimated up to 131 million people with dementia will live in the world by 2050. Thus, there
      is a need of sensitive and specific cognitive assessment tools to detect cognitive
      impairment. It enables to provide timely intervention to delay the disease progression,
      prolong independence, and enhance the quality of life (QoL) and personal dignity of the
      individual with dementia.

      Dementia is neurodegenerative disease characterized by progressive, irreversible and still
      incurable cognitive decline. People suffering from dementia retain their positive personality
      traits and character. However, as the illness progresses, symptoms such as memory loss,
      speech impairment, disorientation, difficulties with activities of daily living, and
      self-neglect are common. This leads to a significant interference with everyday social and
      work activities and has a negative impact on subjective perception of dignity. At present,
      the Mini Mental State Examination (MMSE) is used in the Czech Republic to diagnose dementia.
      Due to copyright issues with the MMSE (similar to the Montreal Cognitive Assessment [MoCA]
      questionnaire), there is a need for another valid tool to be free available in the country.
      Currently, the most frequently used tool in the world is the Addenbrooke's Cognitive
      Examination III (ACE-III), which is composed of five domains: orientation and attention;
      memory; fluency; language, and visuospatial function. The ACE-III-J is a sensitive and
      specific screening test to diagnose dementia, and it was better than the MMSE in accuracy for
      identifying dementia.

      Dignity is described as an integral part of QoL. Similarly to QoL, dignity can also be
      understood as a multidimensional concept including: dignity of identity
      (self-worth/worthiness, integrity, trust); dignity as a human right (equality, freedom of
      choice); and dignity as expression of autonomy (independence, control. There are three main
      dimensions essential for constituting dignity: A historical dignity-dimension, acknowledging
      one's own life projects and history; an intrapersonal dignity-dimension, recognizing one's
      own human worth, and living according to individual values; and an interpersonal
      dignity-dimension, experiencing being part of a caring and confirming society.

      Jacobson (2007) says that dignity exists in two complementary, yet disparate forms. It is
      understood as a dualistic concept incorporating absolute and relative dignity, objective and
      subjective dignity, and personal and social dignity. Personal dignity is a type of dignity
      that is subjectively perceived by an individual and is linked to a sense of worthiness.
      However, personal dignity is also contingent and contextual, and can be influenced both by an
      internal aspect, which is the worth and self-respect one ascribes to oneself, as well as by
      an external aspect, which is the worth and value ascribed to the individual by others.

      Patients with a severe chronic disease (such as neurodegenerative) experience existential
      concerns related to changes in the self because of the disease, as well as the social
      consequences of the disease (e.g. embarrassment, role changes, loss of independence, and
      stigmatization), which can severely affect the sense of personal dignity.

      Older adults with dementia (OAwD) are often experiencing an ongoing loss of personal dignity,
      value and security, and experiencing cognitive decline can be a threat towards self-respect
      and the sense of dignity. The key element of the dementia experience is the effort to
      preserve one's identity or sense of self and to preserve a meaningful life. Multiple personal
      losses and changes such as increased dependency, loss of autonomy and gradual loss of
      abilities or competencies can have a negative impact on the sense of self and the self-esteem
      of dementia sufferers. Thus, OAwD are in risk of personal dignity loss due to both impact of
      the disease on their identity and self-esteem, and indirectly through negative social
      interactions and experiences. Before entering the stage of severe dementia individuals are
      aware of the progressive decline in their abilities and actively try to cope with this
      decline. A sound sense of personal dignity is essential to the individual's overall
      experience of well-being and his/her QoL. Investigation of the factors that maintain and
      strengthen personal dignity needs to incorporate data collected from those afflicted.
      However, research how having dementia may impact personal dignity into person's subjective
      experience of mild to moderate dementia is only very recent.

      Pilot data The proposed grant project builds on results of a previous project Trajectories of
      quality of life by the elderly in in early-stage dementia (No. 16-28628A). The findings of
      the project confirm that OAwD assess their QoL better when they have a greater sense of
      personal dignity. The validated Czech version of Patient Dignity Inventory (PDI-CZ) created
      and tested in our project No. 16-28628A will be used in the proposed project.

      B. Project objectives, project timeline and description of methods and approaches To define
      the factors that pose a threat to personal dignity gives an opportunity for a deeper
      understanding of these issues. This can subsequently assist healthcare staff with choosing
      the optimum interventions supporting QoL amongst OAwD. The proposed project responds to a
      society-wide need to identify and solve psychosocial needs of an ageing population with
      emphasis on neurodegenerative diseases.

      The objective of the project is to investigate the changes in the perception of personal
      dignity of OAwD. The opportunity to define risk factors threatening personal dignity over the
      course of dementia will contribute to a deeper understanding of patients' needs. This will
      help healthcare workers choose the optimum psychosocial interventions in accordance with
      Evidence Based Practice and thus protect dignity of OAwD as a major component of QoL. This
      may have a positive effect on the psycho-social dimension of QoL amongst OAwD and may lower
      the frequency and length of hospitalizations as well as save costs on healthcare and social
      services.

      The main aim is to ascertain how the subjective perception of personal dignity in OAwD
      changes throughout the course of this disease (trajectory of personal dignity perception) and
      which factors affect it. Because different types of dementia might have different perceptions
      of personal dignity related to specific disturbances of cognitive domains, post-hoc subgroup
      analysis in different forms of dementia will be performed. For the assessment of cognition
      and diagnosis of dementia, the Addenbrooke's Cognitive Examination III (ACE-III), POBAV, and
      ALBA questionnaires will be used. For this reason, we need to create and validate a Czech
      version of the ACE-III as the first stage of the project.

      In order to achieve the main aim, five sub-aims were identified which should make it possible
      to ascertain subjective perception of personal dignity and factors which affect in amongst
      OAwD:

        1. to create a Czech version of the ACE-III and to conduct a psychometric validation;

        2. to ascertain how the assessment of personal dignity changes over the course of 2 years;

        3. to identify sociodemographic and clinical factors perceived as a threat to dignity;

        4. post-hoc subgroup analysis of results among the different types of dementia;

        5. to define the differences in the perception of personal dignity among OAwD when using
           quantitative (PDI-CZ) and qualitative (in-depth interview) methods.

      C. Methodology In order to reach the set aims, a mixed methods research design (quantitative
      survey first follow by qualitative interview) will be used to carry out a longitudinal,
      prospective study.

      In the quantitative phase of the project using a battery of standardized questionnaires (3
      stages). Research nurse gave QAwD the questionnaires and explained how to complete them. The
      questionnaires will be completed on project enrolment and then two more times at a 12-month
      interval.

      In the qualitative phase of the research, individual in-depth interviews with OAwD on the
      topic of dignity (two interviews with each respondent at a 12-month interval) will be
      conducted, recorded, and transcribed with a subsequent interpretative phenomenological
      analysis. Two psychologists will be undertaking the interviews, in order to ensure that the
      interviews are conducted in the most sensitive manner. Informed consent will be secured
      before each interview. This will be carried out throughout project lifetime.

      Questionnaire battery will be included: Addenbrooke's Cognitive Examination III (ACE-III),
      Amnesia Light and Brief Assessment (ALBA), POBAV, Patient Dignity Inventory (PDI-CZ), Bristol
      Activities of Daily Living Scale (BADLS-CZ), Geriatric Depression Scale (GDS), and a batch of
      socio-demographic and clinical characteristics (including age, sex, level of education,
      living arrangement, social life, frequency of social visits, telephone contact with
      relatives/friends, and the daytime spent alone, illnesses, medication, etc).

      Sample The sample will consist of community-dwelling (i.e., living at home) older adults.
      They will be addressed together with their family caregivers in neurologic and geriatric
      outpatient offices.

      Sample size:

      First sample (quantitative research) will comprise of 500 respondents (310 OAwD for the
      longitudinal, three-stage study and 190 older adults for the validation study ACE-III).

      Second sample (qualitative research) - after evaluating the 1st stage of the quantitative
      research, we will select 10 OAwD from the sample group with high level (average scale more
      than 3) and 10 OAwD who have low level of dignity to understand the different perspectives of
      perception of personal dignity. The exact number of respondents will depend on the thematic
      saturation in the course of interviewing.

      Data from the quantitative research (validation study, and longitudinal study) will be
      gathered using a questionnaire from 310 OAwD (longitudinal study) and 190 older adults (half
      with dementia and half without dementia; validation study ACE-III) in neurologic and
      geriatric outpatients' departments in four regions of the Czech Republic. All data will be
      inserted into CASTOR database, from which they will be exported for statistical processing.

      Data from the qualitative phase will be gathered using in-depth interviews with 20 OAwD.
      These respondents we will select after evaluation the 1st stage of the quantitative research
      (10 OAwD with high and 10 OAwD with low levels of dignity to understand the different
      perspectives in perception of personal dignity). An interpretative phenomenological analysis
      (IPA) will be applied. The IPA is an approach of a qualitative research, which is used to
      examine how people make sense of their major life experiences. The method is often used to
      study patients' lived experience. The data will be coded in NVivo 12 software for analysis.
      To assure reliability of the analysis, two researchers will code the interviews independently
      and they will confront their results for similarities and differences.
observational model: Case-Control
time perspective: Prospective
measure: Addenbrooke's Cognitive Examination III (ACE-III)
time frame: 12 months
description: To create a Czech version of the ACE-III and to conduct a psychometric validation
measure: Patient Dignity Inventory (PDI)
time frame: 24 months
description: To ascertain how the assessment of personal dignity changes over the course of two years
measure: Factors affecting dignity
time frame: 24 months
description: To identify sociodemographic and clinical factors perceived as a threat to dignity (including age, sex, level of education, living arrangement, social life, frequency of social visits, telephone contact with relatives/friends, and the daytime spent alone, illnesses, depression, self-sufficiency etc).
measure: Differences in the perception of personal dignity
time frame: 24 months
description: To define the differences in the perception of personal dignity among OAwD when using quantitative (PDI-CZ) and qualitative (in-depth interview) methods.
measure: Dignity among the different types of dementia
time frame: 24 months
description: Post-hoc subgroup analysis of results among the different types of dementia
arm group label: participants with early stage dementia
description: Subjects with diagnosed any type of dementia at an early phase (MMSE score 20 - 25 points) - for longitudinal study (three phasis).
arm group label: participants without dementia
description: Subjects without dementia with MMSE score 26 - 30 points (for validation of ACE-III).
intervention type: Behavioral
intervention name: questionnaire
description: Questionnaire battery for assessment of dignity, cognition, self-sufficiency, and depression.
arm group label: participants with early stage dementia
arm group label: participants without dementia
intervention type: Behavioral
intervention name: in-depth interview
description: Individual in-depth interviews with OAwD on the topic of dignity (two interviews with each respondent at a 12-month interval) .
arm group label: participants with early stage dementia
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 60 Years
maximum age: 100 Years
healthy volunteers: No
last name: Helena Kisvetrova, PhD
role: Principal Investigator
affiliation: Faculty of Health Sciences Palacky University Olomouc
facility: 
facility: 
facility: 
facility: 
facility: 
country: Czechia
responsible party type: Principal Investigator
investigator affiliation: Palacky University
investigator full name: Helena Kisvetrova
investigator title: Principal Investigator
mesh term: Dementia
sharing ipd: Undecided