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Identifying the Course of Dementia Using Medical Records: the CoMed Study (CoMed)

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ClinicalTrials.gov Identifier: NCT03817138
Recruitment Status : Not yet recruiting
First Posted : January 25, 2019
Last Update Posted : February 4, 2019
Sponsor:
Collaborators:
The Dunhill Medical Trust
Midlands Partnership NHS Foundation Trust
University of Sheffield
University of Warwick
University College, London
Newcastle University
Information provided by (Responsible Party):
Keele University

Brief Summary:
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.

Condition or disease Intervention/treatment
Dementia Other: Exposures: Markers of disease progression

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Identifying the Course of Dementia Using Medical Records: the CoMed Study
Estimated Study Start Date : March 2019
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia


Intervention Details:
  • Other: Exposures: Markers of disease progression
    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 Names:
    • Cognitive function
    • Neuropsychiatric symptoms of dementia
    • Daily functioning
    • Care
    • Comorbidity
    • Health care utilisation
    • Tests and investigations


Primary Outcome Measures :
  1. 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)] ]
    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).

  2. 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)] ]
    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).

  3. 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)] ]
    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).

  4. 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)] ]
    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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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 (timescale is necessary to determine disease progression). The first 1000 eligible patients will be initially identified (expected number required to obtain sample size requirement of 400 patients), however further searches can be carried out if the expected response and recruitment rate is not met.
Criteria

Inclusion Criteria:

  • Adults aged 18 years and over
  • Confirmed diagnosis of dementia in the dementia service medical records
  • Assessment by the dementia service on two or more occasions at least 12 months apart (timescale required to determine disease progression)
  • Recorded appointment with the dementia service in last 12 months

Exclusion Criteria:

  • Lists of patients who are potentially eligible to take part will be screened by their respective clinical care teams to exclude those who may have significant issues (e.g. significant life event) where contact to participate may cause harm or additional distress or who have indicated that they do not wish to be part of any research or for their data to be shared including those expressed as an advance directive or statement.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03817138


Contacts
Contact: Michelle Marshall, PhD 0044 1782 734872 m.marshall@keele.ac.uk
Contact: Paul Campbell, PhD 0044 1782 734828 p.campbell@keele.ac.uk

Locations
United Kingdom
Midlands Partnership NHS Foundation Trust Not yet recruiting
Stafford, Staffordshire, United Kingdom, ST16 3SR
Contact: Michelle Marshall, PhD    0044 1782 734872    m.marshall@keele.ac.uk   
Contact: Paul Campbell, PhD    0044 1782 734828    p.campbell@keele.ac.uk   
Sponsors and Collaborators
Keele University
The Dunhill Medical Trust
Midlands Partnership NHS Foundation Trust
University of Sheffield
University of Warwick
University College, London
Newcastle University
Investigators
Study Director: Kelvin Jordan, PhD Keele University

Responsible Party: Keele University
ClinicalTrials.gov Identifier: NCT03817138     History of Changes
Other Study ID Numbers: RG-0280-18
First Posted: January 25, 2019    Key Record Dates
Last Update Posted: February 4, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Keele University:
Primary Care
Disease Progression
Electronic Health Records
Medical Records
Prognosis

Additional relevant MeSH terms:
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders