Dementia, Alzheimer, Electronic Health Records, Hospitalizations, Epidemiology, Comorbidity, United Kingdom, Incidence, Mortality, Cause of DeathNCT04321486
Natural History and Patient Journey in Dementia: a Nationwide Linked Electronic Health Records Study of 5.6 Million Individuals.
An observational study of Dementia, Alzheimer, Electronic Health Records, Hospitalizations, Epidemiology, Comorbidity, United Kingdom, Incidence, Mortality, Cause of Death, run by University College, London.
Trial summary
The trajectory of dementia patients within the national health system and their recent temporal trends remains to be fully elucidated. To study the dementia incidence, mortality and case-fatality, we implemented a longitudinal cohort study with the linked electronic health records of 5.6 million population in the UK… Read more about this study
- Who is it for?
- Ages 30 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia, Alzheimer, Electronic Health Records, Hospitalizations, Epidemiology, Comorbidity, United Kingdom, Incidence, Mortality, Cause of Death
- What is being tested?
- The study does not have an intervention, but observe the dementia incidence of the UK disease-free population.
- How many people
- 4,309,481 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 1998to 30 Nov 2020
- 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 30 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: We implement two study designs, first a longitudinal cohort study to assess dementia incidence and second a matched case-control study for mortality, cause of death and hospitalization. We identify individuals aged 30 years or older and registered in the current primary care practice for at least one year. Individuals are excluded if they had a prior history of dementia before study entry. For the nested case-control study, controls are matched to incident dementia patients according to sex and age (10-year age strata).
Who may be able to join
- We identify individuals aged 30 years or older and registered in the current primary care practice for at least one year.
Who cannot join
- Individuals are excluded if they had a prior history of dementia before study entry.
About this study
The trajectory of dementia patients within the national health system and their recent temporal trends remains to be fully elucidated. To study the dementia incidence, mortality and case-fatality, we implemented a longitudinal cohort study with the linked electronic health records of 5.6 million population in the UK from 1998 to 2016 (CALIBER). A matched case-control study design was used to investigate the causes of hospitalization and death comparing individuals with and without incident dementia.
- Being tested
- The study does not have an intervention, but observe the dementia incidence of the UK disease-free population.
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The study does not have an intervention, but observe the dementia incidence of the UK disease-free population.Other
The study does not have an intervention, but observe the dementia incidence of the UK disease-free population.
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and mortality of dementia
Measured: Jan 1st 1998 - May 31st 2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2020
- Study start1 Jan 1998
- Primary completion31 May 2016
- Study completion30 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dementia, Alzheimer, Electronic Health Records, Hospitalizations, Epidemiology, Comorbidity, United Kingdom, Incidence, Mortality, Cause of DeathStudies 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
- Prospective
- Enrolment
- 4,309,481 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04321486
- Sponsor's protocol ID
- ISAC18_228
- Status last verified
- Mar 2020
- First submitted
- 23 Mar 2020
- Last updated
- 13 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natural History and Patient Journey in Dementia: a Nationwide Linked Electronic Health Records Study of 5.6 Million Individuals.
- ClinicalTrials.gov ID
- NCT04321486
- Acronym / sponsor ID
- ISAC18_228
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,309,481 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- 1 Jan 1998 (actual)
- Primary completion
- 31 May 2016 (actual)
- Study completion
- 30 Nov 2020 (estimated)
- First posted
- 25 Mar 2020 (actual)
- 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.
The trajectory of dementia patients within the national health system and their recent temporal trends remains to be fully elucidated. To study the dementia incidence, mortality and case-fatality, we implemented a longitudinal cohort study with the linked electronic health records of 5.6 million population in the UK from 1998 to 2016 (CALIBER). A matched case-control study design was used to investigate the causes of hospitalization and death comparing individuals with and without incident dementia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- We implement two study designs, first a longitudinal cohort study to assess dementia incidence and second a matched case-control study for mortality, cause of death and hospitalization. We identify individuals aged 30 years or older and registered in the current primary care practice for at least one year. Individuals are excluded if they had a prior history of dementia before study entry. For the nested case-control study, controls are matched to incident dementia patients according to sex and age (10-year age strata).
Key inclusion criteria (1 listed)
- We identify individuals aged 30 years or older and registered in the current primary care practice for at least one year.
Key exclusion criteria (1 listed)
- Individuals are excluded if they had a prior history of dementia before study entry.
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 |
|---|---|---|
| The study does not have an intervention, but observe the dementia incidence of the UK disease-free population.The study does not have an intervention, but observe the dementia incidence of the UK disease-free population. | Other | – |
Primary outcome
Incidence and mortality of dementia
Time frame: Jan 1st 1998 - May 31st 2016
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2020.
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Dementia, Alzheimer, Electronic Health Records, Hospitalizations, Epidemiology, Comorbidity, United Kingdom, Incidence, Mortality, Cause of Death, run by University College, London.
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 1 inclusion and 1 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 13 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Incidence and mortality of dementia (time frame: Jan 1st 1998 - May 31st 2016). 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 13 Nov 2020.