NCT05371782

Brief Summary

The objective of this study is to develop and validate a clinical prediction tool to estimate 1-year mortality among hospitalized patients with dementia.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
298,576

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2009

Longer than P75 for all trials

Status
completed

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

April 1, 2009

Completed
11 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

May 7, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 12, 2022

Completed
Last Updated

May 12, 2022

Status Verified

May 1, 2022

Enrollment Period

11 years

First QC Date

May 7, 2022

Last Update Submit

May 7, 2022

Conditions

Keywords

Prediction modelPrognosis

Outcome Measures

Primary Outcomes (1)

  • Mortality

    Derived from population-based administrative database

    Within 1 year of admission

Study Arms (2)

Derivation cohort

The derivation cohort will comprise about 235,000 patients with dementia, who were admitted to a hospital in Ontario from April 1st, 2009 to December 31st, 2017.

Validation cohort

The validation cohort will comprise about 63,000 dementia patients, who were admitted to a hospital in Ontario from January 1st, 2018 to March 31st, 2019.

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

The derivation cohort will comprise about 235,000 patients with dementia, who were admitted to a hospital in Ontario from April 1st, 2009 to December 31st, 2017. The validation cohort will comprise about 63,000 dementia patients, who were admitted to a hospital in Ontario from January 1st, 2018 to March 31st, 2019.

You may qualify if:

  • Diagnosis of dementia using a validated algorithm to identify cases based on a combination of hospital codes, physician claims, and prescribed medications that are specific to dementia
  • Hospitalization at least once from March 31st, 2009, to April 1st, 2019

You may not qualify if:

  • Age \<65 years at the time of index admission
  • Ineligibility for universal health insurance at the time of admission

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Bonares M, Fisher S, Quinn K, Wentlandt K, Tanuseputro P. Study protocol for the development and validation of a clinical prediction tool to estimate the risk of 1-year mortality among hospitalized patients with dementia. Diagn Progn Res. 2024 Mar 19;8(1):5. doi: 10.1186/s41512-024-00168-2.

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
Lecturer

Study Record Dates

First Submitted

May 7, 2022

First Posted

May 12, 2022

Study Start

April 1, 2009

Primary Completion

March 31, 2020

Study Completion

March 31, 2020

Last Updated

May 12, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share