- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02549872
Dementia Phenotypes in Primary Care, Hospital, and National Mortality Registries
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
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Anticipato)
Contatti e Sedi
Luoghi di studio
-
-
-
London, Regno Unito
- London Farr Institute of Health Informatics
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
---|---|
Dementia
Patients with a recorded diagnosis of dementia in primary or secondary care
|
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
|
This study is based on the retrospective analysis of linked electronic health records.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Proportion of patients with dementia diagnosis (any type) in primary care that also are recorded in secondary care
Lasso di tempo: 10 years
|
10 years
|
|
Factors associated with dementia diagnosis (any type) recording in mortality data only
Lasso di tempo: 10 years
|
These will be estimated from multivariable logistic regression models
|
10 years
|
Symptoms associated with subsequent diagnosis of dementia
Lasso di tempo: 10 years
|
These will be estimated from multivariable logistic regression models
|
10 years
|
Lifetime risk of dementia (any type)
Lasso di tempo: 10 years
|
10 years
|
|
Lifetime risk of mortality associated with dementia (any time)
Lasso di tempo: 10 years
|
10 years
|
|
Factors associated with dementia diagnosis (any type) recording in secondary care only
Lasso di tempo: 10 years
|
These will be estimated from multivariable logistic regression models
|
10 years
|
Factors associated with dementia diagnosis (any type) recording in primary care only
Lasso di tempo: 10 years
|
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
Lasso di tempo: 10 years
|
10 years
|
|
Proportion of patients with dementia diagnosis (any type) in secondary care that also are recorded in mortality data
Lasso di tempo: 10 years
|
10 years
|
Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
---|---|
Proportion of patients with Alzheimer's disease in primary care that are also diagnosed in secondary care
Lasso di tempo: 10 years
|
10 years
|
Proportion of patients with vascular dementia in primary care that are also diagnosed in secondary care
Lasso di tempo: 10 years
|
10 years
|
Lifetime risk of Alzheimer's disease
Lasso di tempo: 10 years
|
10 years
|
Lifetime risk of vascular dementia
Lasso di tempo: 10 years
|
10 years
|
Lifetime risk of mortality associated with Alzheimer's disease
Lasso di tempo: 10 years
|
10 years
|
Proportion of patients with Alzheimer's disease in primary care that are also diagnosed in mortality data
Lasso di tempo: 10 years
|
10 years
|
Proportion of patients with Alzheimer's disease in secondary care that are also recorded in mortality data
Lasso di tempo: 10 years
|
10 years
|
Proportion of patients with vascular dementia in primary care that are also recorded in secondary care
Lasso di tempo: 10 years
|
10 years
|
Proportion of patients with vascular dementia in secondary care that are also recorded in mortality data
Lasso di tempo: 10 years
|
10 years
|
Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 15_138
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .