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

NCT03817138 | Completed

• 1 other identifier: RG-0280-18
• Study Type: observational
• Target: 258
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia

Keywords

Primary Care; Disease Progression; Electronic Health Records; Medical Records; Prognosis

Outcome Measures

Primary Outcomes (4)

• Change in Mini-Mental State Examination score

  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).

  [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

  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).

  [Time Frame: Determined for each patient by their earliest assessment (baseline) and latest assessment (a minimum of 12 months)]

• Change in Neuropsychiatric Inventory score

  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).

  [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

  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).

  [Time Frame: Determined for each patient by their earliest assessment (baseline) and latest assessment (a minimum of 12 months)]

Interventions

Exposures: Markers of disease progression OTHER

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.

Also known as: Cognitive function, Neuropsychiatric symptoms of dementia, Daily functioning, Care, Comorbidity, Health care utilisation, Tests and investigations

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Keele University: lead
• The Dunhill Medical Trust: collaborator
• Midlands Partnership NHS Foundation Trust: collaborator
• University of Sheffield: collaborator
• University of Warwick: collaborator
• University College, London: collaborator
• Newcastle University: collaborator

Study Sites (1)

Midlands Partnership NHS Foundation Trust

Stafford, Staffordshire, ST16 3SR, United Kingdom

Location

MeSH Terms

Conditions

Dementia; Disease Progression

Interventions

Neuropsychological Tests; Comorbidity

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Psychological Tests; Behavioral Disciplines and Activities; Epidemiologic Factors; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Kelvin Jordan, PhD

  Keele University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2019
• First Posted: January 25, 2019
• Study Start: July 9, 2019
• Primary Completion: January 6, 2020
• Study Completion: January 6, 2020
• Last Updated: February 20, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)