Development and Validation of a Dementia Life Expectancy Tool

NCT06266325 | Completed

• 1 other identifier: 6138
• Study Type: observational
• Target: 202,217
• Locations: 0 countries
• Sites: N/A

Brief Summary

Individuals with dementia and their caregivers are faced with challenging decisions throughout the course of the disease. These decisions may be about medical care (e.g., continuation of routine cancer screening, pursuit of cardiopulmonary resuscitation, initiation of palliative care services), institutionalization (i.e., transition to a long-term care facility), or financial planning. These inherently difficult decisions are made more difficult by prognostic uncertainty. Indeed, life expectancy is challenging to predict in dementia. Consequently, prognosis is infrequently discussed by healthcare providers with individuals with dementia and their families, which compromises their ability to plan for the future. A lack of prognostic awareness makes it difficult for patients, their caregivers, and their healthcare providers to make medical decisions that strike the appropriate balance between prolonging life and promoting the quality of it. A clinical prediction tool has the promise to provide personalized and accurate estimations of life expectancy in individuals with dementia. Therefore, similar to the existing clinical prediction tools on our Project Big Life platform (www.projectbiglife.ca), we seek to create and to test a statistical model to predict survival, and to implement the model as a user-friendly, web-based calculator. The calculator will use self-reported sociodemographic, clinical, cognitive, functional, and nutritional information that is entered by patients, their caregivers, and/or their healthcare providers to output an estimated life expectancy. This estimate could inform the shared decision-making process, thereby empowering decisions that are compatible with a patient's clinical reality and concordant with their life goals.

Conditions

Dementia; Death

Keywords

Predictive Medicine

Outcome Measures

Primary Outcomes (1)

• Mortality

  Operationalized as time-to-event outcome

  Maximum follow-up date is December 31, 2022

Study Arms (2)

Derivation

Individuals whose randomly selected assessment was done between April 1, 2010 and March 31, 2018, in whom model will be developed

Other: There is no intervention. Exposures are predictor variables of mortality.

Validation

Individuals whose randomly selected assessment was done between April 1, 2018 and March 31, 2020, in whom model's performance will be assessed

Other: There is no intervention. Exposures are predictor variables of mortality.

Interventions

There is no intervention. Exposures are predictor variables of mortality. OTHER

Predictor variables of mortality will be in following categories: sociodemographic, clinical (comorbidities, treatment), caregiver-specific, functional, nutritional, cognitive, psychological/behavioural, home care, healthcare utilization, and assessment-specific information.

Derivation; Validation

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The cohort will comprise individuals with dementia who are expected to be or currently are recipients of long-stay home care, who, after diagnosis of dementia, underwent any home care assessment from April 1st, 2010 to March 31st, 2020

You may qualify if:

• Diagnosed with dementia determined by a combination of a validated case definition and by indicators of dementia in the home care assessment
• Recipients of home care, who, after diagnosis of dementia, underwent any home care assessment from April 1st, 2010 to March 31st, 2020

You may not qualify if:

• Age \<65 on the date of dementia diagnosis
• Invalid age or sex
• Invalid birthdate (e.g., after date of dementia diagnosis) or death date (e.g., before date of dementia diagnosis)
• Ineligibility for Ontario Health Insurance Program at the time of the home care assessment

Sponsors & Collaborators

• University of Toronto: lead
• Sunnybrook Research Institute: collaborator
• Ottawa Hospital Research Institute: collaborator
• ICES: collaborator

Related Publications (1)

• Bonares M, Fisher S, Clarke A, Dover K, Quinn K, Stall N, Isenberg S, Tanuseputro P, Li W. Development and validation of a clinical prediction tool to estimate survival in community-dwelling adults living with dementia: a protocol. BMJ Open. 2024 Nov 17;14(11):e086231. doi: 10.1136/bmjopen-2024-086231.

  PMID: 39551579 DERIVED

MeSH Terms

Conditions

Dementia; Death

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael J Bonares, MD, MSc

  University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 9, 2024
• First Posted: February 20, 2024
• Study Start: April 1, 2010
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: March 4, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share