DementiaNCT02549872
Dementia Phenotypes in Primary Care, Hospital, and National Mortality Registries
An observational study of Dementia, run by University College, London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia
- What is being tested?
- This is not an intervention study
- How many people
- 51,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2015to Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients registered in English general practices contributing with data to the CALIBER research platform from 1997 onward.
Who may be able to join
- 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
Who cannot join
- Patients without recorded gender
- Less than 1 year of follow-up between study entry and date of administrative censoring
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
London Farr Institute of Health Informatics
London
About this study
Official title: Dementia Phenotypes in Primary Care, Hospital, and National Mortality Registries: a Cohort Study in Linked Electronic Health Records
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
Read the 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.
- Conditions
- Dementia
- Being tested
- This is not an intervention study
- Keywords
- Dementia, Validity, Mortality, Electronic health records
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This is not an intervention studyOther
This study is based on the retrospective analysis of linked electronic health records.
| Study group | Role | What they receive |
|---|---|---|
| Dementia | Patients with a recorded diagnosis of dementia in primary or secondary care Receives: Other: This is not an intervention study | |
| Non-dementia | Patients without a recorded diagnosis of dementia in primary or secondary care Receives: Other: This is not an intervention study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with dementia diagnosis (any type) in primary care that also are recorded in secondary care
Measured: 10 years
Factors associated with dementia diagnosis (any type) recording in mortality data only
These will be estimated from multivariable logistic regression models
Measured: 10 years
Symptoms associated with subsequent diagnosis of dementia
These will be estimated from multivariable logistic regression models
Measured: 10 years
Lifetime risk of dementia (any type)
Measured: 10 years
Lifetime risk of mortality associated with dementia (any time)
Measured: 10 years
Factors associated with dementia diagnosis (any type) recording in secondary care only
These will be estimated from multivariable logistic regression models
Measured: 10 years
Factors associated with dementia diagnosis (any type) recording in primary care only
These will be estimated from multivariable logistic regression models
Measured: 10 years
Proportion of patients with dementia diagnosis (any type) in primary care that also are recorded in mortality data
Measured: 10 years
Proportion of patients with dementia diagnosis (any type) in secondary care that also are recorded in mortality data
Measured: 10 years
Secondary outcomes (9)
Proportion of patients with Alzheimer's disease in primary care that are also diagnosed in secondary care
Measured: 10 years
Proportion of patients with vascular dementia in primary care that are also diagnosed in secondary care
Measured: 10 years
Lifetime risk of Alzheimer's disease
Measured: 10 years
Lifetime risk of vascular dementia
Measured: 10 years
Lifetime risk of mortality associated with Alzheimer's disease
Measured: 10 years
Proportion of patients with Alzheimer's disease in primary care that are also diagnosed in mortality data
Measured: 10 years
Proportion of patients with Alzheimer's disease in secondary care that are also recorded in mortality data
Measured: 10 years
Proportion of patients with vascular dementia in primary care that are also recorded in secondary care
Measured: 10 years
Proportion of patients with vascular dementia in secondary care that are also recorded in mortality data
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionOct 2015 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 51,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- University of Edinburgh, University of Leeds, Medical Research Council
- Responsible party
- Principal investigator, Harry Hemingway, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02549872
- Sponsor's protocol ID
- 15_138
- Status last verified
- Sep 2015
- First submitted
- 3 Sep 2015
- Last updated
- 15 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dementia Phenotypes in Primary Care, Hospital, and National Mortality Registries: a Cohort Study in Linked Electronic Health Records
- ClinicalTrials.gov ID
- NCT02549872
- Acronym / sponsor ID
- 15_138
- Conditions
- Dementia
- Keywords
- Dementia, Validity, Mortality, Electronic health records
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 51,000 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- University of Edinburgh, University of Leeds, Medical Research Council
- Study start
- Sep 2015
- Primary completion
- Oct 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 15 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dementia | – | Other: This is not an intervention studyPatients with a recorded diagnosis of dementia in primary or secondary care |
| Non-dementia | – | Other: This is not an intervention studyPatients without a recorded diagnosis of dementia in primary or secondary care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients registered in English general practices contributing with data to the CALIBER research platform from 1997 onward.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Patients without recorded gender
- Less than 1 year of follow-up between study entry and date of administrative censoring
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| This is not an intervention studyThis study is based on the retrospective analysis of linked electronic health records. | Other | Dementia, Non-dementia |
Primary outcome
Proportion of patients with dementia diagnosis (any type) in primary care that also are recorded in secondary care
Time frame: 10 years
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
Symptoms associated with subsequent diagnosis of dementia
Time frame: 10 years
These will be estimated from multivariable logistic regression models
Lifetime risk of dementia (any type)
Time frame: 10 years
Lifetime risk of mortality associated with dementia (any time)
Time frame: 10 years
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
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
Proportion of patients with dementia diagnosis (any type) in primary care that also are recorded in mortality data
Time frame: 10 years
Proportion of patients with dementia diagnosis (any type) in secondary care that also are recorded in mortality data
Time frame: 10 years
9 secondary outcomes
Proportion of patients with Alzheimer's disease in primary care that are also diagnosed in secondary care
Time frame: 10 years
Proportion of patients with vascular dementia in primary care that are also diagnosed in secondary care
Time frame: 10 years
Lifetime risk of Alzheimer's disease
Time frame: 10 years
Lifetime risk of vascular dementia
Time frame: 10 years
Lifetime risk of mortality associated with Alzheimer's disease
Time frame: 10 years
Proportion of patients with Alzheimer's disease in primary care that are also diagnosed in mortality data
Time frame: 10 years
Proportion of patients with Alzheimer's disease in secondary care that are also recorded in mortality data
Time frame: 10 years
Proportion of patients with vascular dementia in primary care that are also recorded in secondary care
Time frame: 10 years
Proportion of patients with vascular dementia in secondary care that are also recorded in mortality data
Time frame: 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dementia, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with dementia diagnosis (any type) in primary care that also are recorded in secondary care (time frame: 10 years). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2015.