NCT02549872

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
51,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

September 3, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 15, 2015

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

September 15, 2015

Status Verified

September 1, 2015

Enrollment Period

1 month

First QC Date

September 3, 2015

Last Update Submit

September 11, 2015

Conditions

Keywords

DementiaValidityMortalityElectronic health records

Outcome Measures

Primary Outcomes (9)

  • Proportion of patients with dementia diagnosis (any type) in primary care that also are recorded in secondary care

    10 years

  • Factors associated with dementia diagnosis (any type) recording in mortality data only

    These will be estimated from multivariable logistic regression models

    10 years

  • Symptoms associated with subsequent diagnosis of dementia

    These will be estimated from multivariable logistic regression models

    10 years

  • Lifetime risk of dementia (any type)

    10 years

  • Lifetime risk of mortality associated with dementia (any time)

    10 years

  • Factors associated with dementia diagnosis (any type) recording in secondary care only

    These will be estimated from multivariable logistic regression models

    10 years

  • Factors associated with dementia diagnosis (any type) recording in primary care only

    These will be estimated from multivariable logistic regression models

    10 years

  • Proportion of patients with dementia diagnosis (any type) in primary care that also are recorded in mortality data

    10 years

  • Proportion of patients with dementia diagnosis (any type) in secondary care that also are recorded in mortality data

    10 years

Secondary Outcomes (9)

  • Proportion of patients with Alzheimer's disease in primary care that are also diagnosed in secondary care

    10 years

  • Proportion of patients with vascular dementia in primary care that are also diagnosed in secondary care

    10 years

  • Lifetime risk of Alzheimer's disease

    10 years

  • Lifetime risk of vascular dementia

    10 years

  • Lifetime risk of mortality associated with Alzheimer's disease

    10 years

  • +4 more secondary outcomes

Study Arms (2)

Dementia

Patients with a recorded diagnosis of dementia in primary or secondary care

Other: This is not an intervention study

Non-dementia

Patients without a recorded diagnosis of dementia in primary or secondary care

Other: This is not an intervention study

Interventions

This study is based on the retrospective analysis of linked electronic health records.

DementiaNon-dementia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients registered in English general practices contributing with data to the CALIBER research platform from 1997 onward.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

London Farr Institute of Health Informatics

London, United Kingdom

Location

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Epidemiology and Public Health

Study Record Dates

First Submitted

September 3, 2015

First Posted

September 15, 2015

Study Start

September 1, 2015

Primary Completion

October 1, 2015

Study Completion

December 1, 2015

Last Updated

September 15, 2015

Record last verified: 2015-09

Locations