<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/NCT03817138</url>
  </required_header>
  <id_info>
    <org_study_id>RG-0280-18</org_study_id>
    <nct_id>NCT03817138</nct_id>
  </id_info>
  <brief_title>Identifying the Course of Dementia Using Medical Records: the CoMed Study</brief_title>
  <acronym>CoMed</acronym>
  <official_title>Identifying the Course of Dementia Using Medical Records: the CoMed Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Keele University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Dunhill Medical Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Midlands Partnership NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Sheffield</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Warwick</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University College, London</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Newcastle University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Keele 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>
      The number of people living with dementia is increasing as the population ages. The UK&#xD;
      government has initiated a &quot;Dementia strategy&quot; to respond to this increase, and has set four&#xD;
      main goals; 1) to identify those with dementia as early as possible, 2) to prolong their&#xD;
      independence, 3) to reduce the need for hospital and nursing home admissions, and 4) to delay&#xD;
      the time until death. So far lots of research has looked at what factors might cause or&#xD;
      increase the risk of dementia, but less is known about how dementia affects people over time&#xD;
      once they have dementia. One of the quickest and efficient ways to identify the actual course&#xD;
      of dementia may be to use existing medical records from primary care. Primary care medical&#xD;
      records are those kept by the patient's GP. Having the ability to look at the course of&#xD;
      dementia over time in these records will help identify people who have a different course&#xD;
      (for example a faster and more severe course) and also identify the factors that alter that&#xD;
      course. This information would be useful to clinicians and indicate potential targets for&#xD;
      treatment in the future to alter the course of someone's disease. To assess whether this is&#xD;
      possible, around 1000 patients with dementia who have recently been seen by a dementia&#xD;
      service (where patients with a diagnosis of dementia are seen normally every year) will be&#xD;
      contacted. Consent to link their primary care medical records (medical records kept by their&#xD;
      GP) to their dementia service medical records will be sought. The target for recruitment is&#xD;
      400 patients who will provide consent. Then the assessment of how well the potential markers&#xD;
      of disease progression identified from primary care medical records relate to actual changes&#xD;
      in disease course from their dementia service medical records can be determined.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The UK government has prioritised early recognition and treatment of dementia, with specific&#xD;
      goals to prolong independence, delay nursing home and hospital admissions, and reduce&#xD;
      mortality. It is recognised that this strategy in the UK health system necessitates primary&#xD;
      care involvement in diagnosis and management of dementia. While advances have been made in&#xD;
      identifying patients with dementia within primary care, there is little research on the&#xD;
      course of the disease after diagnosis, even though information about disease course and the&#xD;
      factors that alter the course are essential to patient management and wider health policy.&#xD;
&#xD;
      One potential major resource for studying these issues in primary care are Electronic Health&#xD;
      Record (EHR) databases which contain routinely recorded information from consultations with a&#xD;
      GP and other healthcare professional such as illnesses and treatment provided. They are a&#xD;
      useful resource for studying how illnesses progress after diagnosis in primary care and have&#xD;
      been used to investigate disease course, outcomes and patient care in a wide spectrum of&#xD;
      diseases. However, to date, they have not been used to research the course of dementia after&#xD;
      diagnosis. Existing evidence has established important dementia outcomes (e.g. nursing home&#xD;
      placement, hospital admissions, mortality) are recorded within EHR and a systematic review&#xD;
      that has recently been performed suggests other illnesses and symptoms (e.g. cognitive&#xD;
      status, neuropsychiatric symptoms), may be recorded within primary care EHR and could serve&#xD;
      as markers of disease progression.&#xD;
&#xD;
      To address this research gap the research will identify possible markers of disease&#xD;
      progression from routinely collected in primary care medical records and compare them against&#xD;
      assessments of disease progression from specialist dementia service medical records. The&#xD;
      study will enable healthcare professionals to use routinely recorded information in primary&#xD;
      care, without the need for intensive assessments, to identify individuals with dementia who&#xD;
      are at risk of a faster disease progression. This will drive the future development and&#xD;
      delivery of treatment to the individual patient with dementia based on their likely future&#xD;
      course.&#xD;
&#xD;
      The CoMed study is a retrospective cohort design linking dementia service and primary care&#xD;
      medical records. Potential participants' only involvement will be a request for consent to&#xD;
      access and link these medical records.&#xD;
&#xD;
      Participants will be recruited from a secondary care dementia service.&#xD;
&#xD;
      All patients who have a confirmed diagnosis of dementia in the dementia service medical&#xD;
      records and who have been assessed by the dementia service at more than one-time point at&#xD;
      least 12 months apart will be identified (a 12-month gap is the minimum necessary to&#xD;
      determine disease progression). The first 1000 eligible patients will be initially identified&#xD;
      (expected number required to obtain sample size required of 400 patients), however, further&#xD;
      searches can be carried out if the expected response and recruitment rate is not met. The&#xD;
      list of patients to be invited will be screened by the patient's clinical care team in the&#xD;
      participating dementia service to exclude those who it would be inappropriate to contact as&#xD;
      it may cause undue distress or harm.&#xD;
&#xD;
      Eligible patients who have been seen by the dementia service within the previous 12 months&#xD;
      will be identified by the dementia service clinical care team. These eligible patients will&#xD;
      be sent by post the study information pack containing: an invitation letter, patient and&#xD;
      personal consultee information leaflets, patient consent and personal consultee declaration&#xD;
      forms, and a stamped addressed return envelope. If there is no reply to the initial&#xD;
      invitation, then a reminder invitation and study information pack will be sent after a&#xD;
      minimum of 2 weeks. A poster about the study will be displayed in the dementia service&#xD;
      clinical areas and waiting areas, and a copy of the poster in leaflet form will be available&#xD;
      for patients to take away and read if they wish.&#xD;
&#xD;
      A review of the response and recruitment rate will be undertaken at regular intervals to&#xD;
      assess whether more patients need to be identified (based on a 40% recruitment rate). If the&#xD;
      required number of patients is not achieved additional recruitment strategy will be&#xD;
      initiated. An additional search of the dementia service medical records to identify further&#xD;
      eligible patients and study packs will be posted out.&#xD;
&#xD;
      For those who are willing to take part in the study written informed consent will be obtained&#xD;
      from patients with dementia (or personal consultee's advice for those not able to give&#xD;
      consent) to access their dementia service medical records and their primary care medical&#xD;
      records and for these to be linked and used for research purposes.&#xD;
&#xD;
      In those consenting to take part in the study, patient data will be retrieved from the&#xD;
      dementia service records including detailed clinical assessments of cognitive status,&#xD;
      behavioural and function assessments, and the time points of these assessments. The patient's&#xD;
      primary care medical records will be requested from their GP practice. Details on how to&#xD;
      electronically download the requested medical records and securely transfer them via the&#xD;
      secure NHS email system will be included with the letter to GP practices.&#xD;
&#xD;
      Confidentiality and anonymity will be maintained for all participants. All information&#xD;
      collected regarding participants will be kept confidential. Participants will be free to&#xD;
      withdraw from the study and to request their medical records are not used up to a period of&#xD;
      one month from the date consent is given. After this point, pseudoanonymised data will be&#xD;
      used and it will not be possible to identify patients to remove their medical records from&#xD;
      the analysis dataset. The presence or absence of potential markers of progression recorded in&#xD;
      patients' primary care records will then be compared to change in scores from standard clinic&#xD;
      assessments recorded at the specialist dementia clinic.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 9, 2019</start_date>
  <completion_date type="Actual">January 6, 2020</completion_date>
  <primary_completion_date type="Actual">January 6, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Mini-Mental State Examination score</measure>
    <time_frame>[Time Frame: Determined for each patient by their earliest assessment (baseline) and latest assessment (a minimum of 12 months)]</time_frame>
    <description>Change in Mini-Mental State Examination score as a measure of cognitive status determined at clinical assessments at the specialist dementia clinics (total score range 0-30, with higher scores indicating greater cognitive impairment).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Addenbrookes Cognitive Examination score</measure>
    <time_frame>[Time Frame: Determined for each patient by their earliest assessment (baseline) and latest assessment (a minimum of 12 months)]</time_frame>
    <description>Change in Addenbrookes Cognitive Examination score as a measure of cognitive status determined at clinical assessments at the specialist dementia clinics (total score range 0-100, with higher scores indicating greater cognitive impairment).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Neuropsychiatric Inventory score</measure>
    <time_frame>[Time Frame: Determined for each patient by their earliest assessment (baseline) and latest assessment (a minimum of 12 months)]</time_frame>
    <description>Change in in Neuropsychiatric Inventory score as a measure of behavioural and psychological symptoms scores determined from clinical assessments at the specialist dementia clinics (total score range 0-36, with higher scores indicating more severe behavioural and psychological symptoms).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Bristol Activities of Daily Living Scale score</measure>
    <time_frame>[Time Frame: Determined for each patient by their earliest assessment (baseline) and latest assessment (a minimum of 12 months)]</time_frame>
    <description>Change in Bristol Activities of Daily Living Scale score as a measure of daily functioning u determined at clinical assessments at the specialist dementia clinics (total scores range 0-60, with higher scores indicating greater loss of competence in undertaking activities of everyday living).</description>
  </primary_outcome>
  <enrollment type="Actual">258</enrollment>
  <condition>Dementia</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exposures: Markers of disease progression</intervention_name>
    <description>From early phases of the study, it is expected that six main domains will be assessed which will include over N=100 potential markers reflecting different markers of dementia disease progression identifiable from patients' primary care EHR.</description>
    <other_name>Cognitive function</other_name>
    <other_name>Neuropsychiatric symptoms of dementia</other_name>
    <other_name>Daily functioning</other_name>
    <other_name>Care</other_name>
    <other_name>Comorbidity</other_name>
    <other_name>Health care utilisation</other_name>
    <other_name>Tests and investigations</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Participants will be recruited from a secondary care dementia service. All patients who&#xD;
        have a confirmed diagnosis of dementia in the dementia service medical records and who have&#xD;
        been assessed by the dementia service at more than one-time point at least 12 months apart&#xD;
        will be identified (timescale is necessary to determine disease progression). The first&#xD;
        1000 eligible patients will be initially identified (expected number required to obtain&#xD;
        sample size requirement of 400 patients), however further searches can be carried out if&#xD;
        the expected response and recruitment rate is not met.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults aged 18 years and over&#xD;
&#xD;
          -  Confirmed diagnosis of dementia in the dementia service medical records&#xD;
&#xD;
          -  Assessment by the dementia service on two or more occasions at least 12 months apart&#xD;
             (timescale required to determine disease progression)&#xD;
&#xD;
          -  Recorded appointment with the dementia service in last 12 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Lists of patients who are potentially eligible to take part will be screened by their&#xD;
             respective clinical care teams to exclude those who may have significant issues (e.g.&#xD;
             significant life event) where contact to participate may cause harm or additional&#xD;
             distress or who have indicated that they do not wish to be part of any research or for&#xD;
             their data to be shared including those expressed as an advance directive or&#xD;
             statement.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kelvin Jordan, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Keele University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Midlands Partnership NHS Foundation Trust</name>
      <address>
        <city>Stafford</city>
        <state>Staffordshire</state>
        <zip>ST16 3SR</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>January 8, 2019</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>February 19, 2020</last_update_submitted>
  <last_update_submitted_qc>February 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Primary Care</keyword>
  <keyword>Disease Progression</keyword>
  <keyword>Electronic Health Records</keyword>
  <keyword>Medical Records</keyword>
  <keyword>Prognosis</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>No</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/NCT03817138
org study id: RG-0280-18
nct id: NCT03817138
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The number of people living with dementia is increasing as the population ages. The UK
      government has initiated a "Dementia strategy" to respond to this increase, and has set four
      main goals; 1) to identify those with dementia as early as possible, 2) to prolong their
      independence, 3) to reduce the need for hospital and nursing home admissions, and 4) to delay
      the time until death. So far lots of research has looked at what factors might cause or
      increase the risk of dementia, but less is known about how dementia affects people over time
      once they have dementia. One of the quickest and efficient ways to identify the actual course
      of dementia may be to use existing medical records from primary care. Primary care medical
      records are those kept by the patient's GP. Having the ability to look at the course of
      dementia over time in these records will help identify people who have a different course
      (for example a faster and more severe course) and also identify the factors that alter that
      course. This information would be useful to clinicians and indicate potential targets for
      treatment in the future to alter the course of someone's disease. To assess whether this is
      possible, around 1000 patients with dementia who have recently been seen by a dementia
      service (where patients with a diagnosis of dementia are seen normally every year) will be
      contacted. Consent to link their primary care medical records (medical records kept by their
      GP) to their dementia service medical records will be sought. The target for recruitment is
      400 patients who will provide consent. Then the assessment of how well the potential markers
      of disease progression identified from primary care medical records relate to actual changes
      in disease course from their dementia service medical records can be determined.
The UK government has prioritised early recognition and treatment of dementia, with specific
      goals to prolong independence, delay nursing home and hospital admissions, and reduce
      mortality. It is recognised that this strategy in the UK health system necessitates primary
      care involvement in diagnosis and management of dementia. While advances have been made in
      identifying patients with dementia within primary care, there is little research on the
      course of the disease after diagnosis, even though information about disease course and the
      factors that alter the course are essential to patient management and wider health policy.

      One potential major resource for studying these issues in primary care are Electronic Health
      Record (EHR) databases which contain routinely recorded information from consultations with a
      GP and other healthcare professional such as illnesses and treatment provided. They are a
      useful resource for studying how illnesses progress after diagnosis in primary care and have
      been used to investigate disease course, outcomes and patient care in a wide spectrum of
      diseases. However, to date, they have not been used to research the course of dementia after
      diagnosis. Existing evidence has established important dementia outcomes (e.g. nursing home
      placement, hospital admissions, mortality) are recorded within EHR and a systematic review
      that has recently been performed suggests other illnesses and symptoms (e.g. cognitive
      status, neuropsychiatric symptoms), may be recorded within primary care EHR and could serve
      as markers of disease progression.

      To address this research gap the research will identify possible markers of disease
      progression from routinely collected in primary care medical records and compare them against
      assessments of disease progression from specialist dementia service medical records. The
      study will enable healthcare professionals to use routinely recorded information in primary
      care, without the need for intensive assessments, to identify individuals with dementia who
      are at risk of a faster disease progression. This will drive the future development and
      delivery of treatment to the individual patient with dementia based on their likely future
      course.

      The CoMed study is a retrospective cohort design linking dementia service and primary care
      medical records. Potential participants' only involvement will be a request for consent to
      access and link these medical records.

      Participants will be recruited from a secondary care dementia service.

      All patients who have a confirmed diagnosis of dementia in the dementia service medical
      records and who have been assessed by the dementia service at more than one-time point at
      least 12 months apart will be identified (a 12-month gap is the minimum necessary to
      determine disease progression). The first 1000 eligible patients will be initially identified
      (expected number required to obtain sample size required of 400 patients), however, further
      searches can be carried out if the expected response and recruitment rate is not met. The
      list of patients to be invited will be screened by the patient's clinical care team in the
      participating dementia service to exclude those who it would be inappropriate to contact as
      it may cause undue distress or harm.

      Eligible patients who have been seen by the dementia service within the previous 12 months
      will be identified by the dementia service clinical care team. These eligible patients will
      be sent by post the study information pack containing: an invitation letter, patient and
      personal consultee information leaflets, patient consent and personal consultee declaration
      forms, and a stamped addressed return envelope. If there is no reply to the initial
      invitation, then a reminder invitation and study information pack will be sent after a
      minimum of 2 weeks. A poster about the study will be displayed in the dementia service
      clinical areas and waiting areas, and a copy of the poster in leaflet form will be available
      for patients to take away and read if they wish.

      A review of the response and recruitment rate will be undertaken at regular intervals to
      assess whether more patients need to be identified (based on a 40% recruitment rate). If the
      required number of patients is not achieved additional recruitment strategy will be
      initiated. An additional search of the dementia service medical records to identify further
      eligible patients and study packs will be posted out.

      For those who are willing to take part in the study written informed consent will be obtained
      from patients with dementia (or personal consultee's advice for those not able to give
      consent) to access their dementia service medical records and their primary care medical
      records and for these to be linked and used for research purposes.

      In those consenting to take part in the study, patient data will be retrieved from the
      dementia service records including detailed clinical assessments of cognitive status,
      behavioural and function assessments, and the time points of these assessments. The patient's
      primary care medical records will be requested from their GP practice. Details on how to
      electronically download the requested medical records and securely transfer them via the
      secure NHS email system will be included with the letter to GP practices.

      Confidentiality and anonymity will be maintained for all participants. All information
      collected regarding participants will be kept confidential. Participants will be free to
      withdraw from the study and to request their medical records are not used up to a period of
      one month from the date consent is given. After this point, pseudoanonymised data will be
      used and it will not be possible to identify patients to remove their medical records from
      the analysis dataset. The presence or absence of potential markers of progression recorded in
      patients' primary care records will then be compared to change in scores from standard clinic
      assessments recorded at the specialist dementia clinic.
observational model: Cohort
time perspective: Retrospective
measure: Change in Mini-Mental State Examination score
time frame: [Time Frame: Determined for each patient by their earliest assessment (baseline) and latest assessment (a minimum of 12 months)]
description: Change in Mini-Mental State Examination score as a measure of cognitive status determined at clinical assessments at the specialist dementia clinics (total score range 0-30, with higher scores indicating greater cognitive impairment).
measure: Change in Addenbrookes Cognitive Examination score
time frame: [Time Frame: Determined for each patient by their earliest assessment (baseline) and latest assessment (a minimum of 12 months)]
description: Change in Addenbrookes Cognitive Examination score as a measure of cognitive status determined at clinical assessments at the specialist dementia clinics (total score range 0-100, with higher scores indicating greater cognitive impairment).
measure: Change in Neuropsychiatric Inventory score
time frame: [Time Frame: Determined for each patient by their earliest assessment (baseline) and latest assessment (a minimum of 12 months)]
description: Change in in Neuropsychiatric Inventory score as a measure of behavioural and psychological symptoms scores determined from clinical assessments at the specialist dementia clinics (total score range 0-36, with higher scores indicating more severe behavioural and psychological symptoms).
measure: Change in Bristol Activities of Daily Living Scale score
time frame: [Time Frame: Determined for each patient by their earliest assessment (baseline) and latest assessment (a minimum of 12 months)]
description: Change in Bristol Activities of Daily Living Scale score as a measure of daily functioning u determined at clinical assessments at the specialist dementia clinics (total scores range 0-60, with higher scores indicating greater loss of competence in undertaking activities of everyday living).
intervention type: Other
intervention name: Exposures: Markers of disease progression
description: From early phases of the study, it is expected that six main domains will be assessed which will include over N=100 potential markers reflecting different markers of dementia disease progression identifiable from patients' primary care EHR.
other name: Cognitive function
other name: Neuropsychiatric symptoms of dementia
other name: Daily functioning
other name: Care
other name: Comorbidity
other name: Health care utilisation
other name: Tests and investigations
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kelvin Jordan, PhD
role: Study Director
affiliation: Keele University
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Dementia
sharing ipd: No