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Trial record 17 of 3210 for:    Dementia

Dementia Phenotypes in Primary Care, Hospital, and National Mortality Registries

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ClinicalTrials.gov Identifier: NCT02549872
Recruitment Status : Unknown
Verified September 2015 by Harry Hemingway, University College, London.
Recruitment status was:  Active, not recruiting
First Posted : September 15, 2015
Last Update Posted : September 15, 2015
Sponsor:
Collaborators:
University of Edinburgh
University of Leeds
Medical Research Council
Information provided by (Responsible Party):
Harry Hemingway, University College, London

Brief Summary:

Most patients with dementia in the UK use their local hospitals and general (family) practices throughout their illness. Linked electronic health records from primary care, hospital and death certificates records therefore provide useful information about the diagnosis and prognosis of patients who develop dementia.

In this study we will assess the validity of dementia diagnoses in linked primary care, hospital and death records, by examining the timing of important health transitions in patients with recorded dementia, and we will estimate the lifetime risk of recorded dementia in different age and sex groups


Condition or disease Intervention/treatment
Dementia Other: This is not an intervention study

Detailed Description:

Dementia is a clinical syndrome with insidious onset that is difficult to diagnose in its earliest stages. Presentation to healthcare depends not only upon the rates of disease progression, but also on social support, recognition by clinicians, and patients' and carers' fear of diagnosis. Maintaining complete follow up in cohorts of patient with dementia is difficult, because patients with dementia are frequently lost to follow up.

Most patients with dementia in the UK use their local hospitals and general (family) practices throughout their illness. Linked electronic health records from primary care, hospital and death certificates records should therefore provide useful information about the diagnosis and prognosis of patients who develop dementia with minimal loss to follow-up rates and improved completeness of diagnosis.

Demonstrating that patients with recorded dementia have an earlier onset of typical symptoms, functional impairment and death than patients in the general population would support the veracity of diagnosed dementia recorded in electronic health records and its use as an outcome or exposure in cohort studies and for evaluating policy. Previous studies have found that dementia is poorly recorded in routine clinical practice in comparison to face-to-face studies, although this varies by setting and region. However, ascertainment may be improved by examining linked, longitudinal resources. Comparing the lifetime risk of dementia calculated from linked electronic health records with lifetime risks from other sources will also be a useful information to support the use of linked electronic health records in dementia research.

Electronic health records contain information on important health transitions in patients with dementia: from the earliest stage of the illness (depression, anxiety, memory complaints); the development of cognitive impairment that manifest as loss of capacity or missed appointments; and significant functional impairment, with admission to nursing homes or hospital admission. In this study, we will assess the validity of dementia diagnoses in linked primary care, hospital and death records, by examining the timing of important health transitions in patients with recorded dementia, and estimate the lifetime risk of recorded dementia in different age and sex groups.


Study Type : Observational
Estimated Enrollment : 51000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Dementia Phenotypes in Primary Care, Hospital, and National Mortality Registries: a Cohort Study in Linked Electronic Health Records
Study Start Date : September 2015
Estimated Primary Completion Date : October 2015
Estimated Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Dementia
Patients with a recorded diagnosis of dementia in primary or secondary care
Other: This is not an intervention study
This study is based on the retrospective analysis of linked electronic health records.

Non-dementia
Patients without a recorded diagnosis of dementia in primary or secondary care
Other: This is not an intervention study
This study is based on the retrospective analysis of linked electronic health records.




Primary Outcome Measures :
  1. Proportion of patients with dementia diagnosis (any type) in primary care that also are recorded in secondary care [ Time Frame: 10 years ]
  2. Factors associated with dementia diagnosis (any type) recording in mortality data only [ Time Frame: 10 years ]
    These will be estimated from multivariable logistic regression models

  3. Symptoms associated with subsequent diagnosis of dementia [ Time Frame: 10 years ]
    These will be estimated from multivariable logistic regression models

  4. Lifetime risk of dementia (any type) [ Time Frame: 10 years ]
  5. Lifetime risk of mortality associated with dementia (any time) [ Time Frame: 10 years ]
  6. Factors associated with dementia diagnosis (any type) recording in secondary care only [ Time Frame: 10 years ]
    These will be estimated from multivariable logistic regression models

  7. Factors associated with dementia diagnosis (any type) recording in primary care only [ Time Frame: 10 years ]
    These will be estimated from multivariable logistic regression models

  8. Proportion of patients with dementia diagnosis (any type) in primary care that also are recorded in mortality data [ Time Frame: 10 years ]
  9. Proportion of patients with dementia diagnosis (any type) in secondary care that also are recorded in mortality data [ Time Frame: 10 years ]

Secondary Outcome Measures :
  1. Proportion of patients with Alzheimer's disease in primary care that are also diagnosed in secondary care [ Time Frame: 10 years ]
  2. Proportion of patients with vascular dementia in primary care that are also diagnosed in secondary care [ Time Frame: 10 years ]
  3. Lifetime risk of Alzheimer's disease [ Time Frame: 10 years ]
  4. Lifetime risk of vascular dementia [ Time Frame: 10 years ]
  5. Lifetime risk of mortality associated with Alzheimer's disease [ Time Frame: 10 years ]
  6. Proportion of patients with Alzheimer's disease in primary care that are also diagnosed in mortality data [ Time Frame: 10 years ]
  7. Proportion of patients with Alzheimer's disease in secondary care that are also recorded in mortality data [ Time Frame: 10 years ]
  8. Proportion of patients with vascular dementia in primary care that are also recorded in secondary care [ Time Frame: 10 years ]
  9. Proportion of patients with vascular dementia in secondary care that are also recorded in mortality data [ Time Frame: 10 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients registered in English general practices contributing with data to the CALIBER research platform from 1997 onward.
Criteria

Inclusion Criteria:

  • Patients aged 18 years and over
  • Registered with a participating general practice during the study period
  • Minimum one year of records prior to study entry meeting CPRD data quality criteria
  • Followed on or after 1 January 1997

Exclusion Criteria:

  • Patients without recorded gender
  • Less than 1 year of follow-up between study entry and date of administrative censoring

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): NCT02549872


Locations
United Kingdom
London Farr Institute of Health Informatics
London, United Kingdom
Sponsors and Collaborators
University College, London
University of Edinburgh
University of Leeds
Medical Research Council

Responsible Party: Harry Hemingway, Professor of Epidemiology and Public Health, University College, London
ClinicalTrials.gov Identifier: NCT02549872     History of Changes
Other Study ID Numbers: 15_138
First Posted: September 15, 2015    Key Record Dates
Last Update Posted: September 15, 2015
Last Verified: September 2015

Keywords provided by Harry Hemingway, University College, London:
Dementia
Validity
Mortality
Electronic health records

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