NCT06540638

Brief Summary

Addressing brain health and cognitive impairment (CI) in the aging population is important, especially in those undergoing surgery. While certain adverse outcomes are beyond control due to various factors, some may be preventable, such as delirium. It is crucial for patients and their families to be fully aware of the heightened risks associated with CI. By discussing the implications for individuals and their families, patients can make informed decisions about their health. Additionally, patients can be better prepared for their post-operative care and informed about post-operative complications. Education is a practical and viable solution to promote awareness and empower individuals to manage their cognitive health, especially in the context of surgery. Also, it can act as an early intervention. Thus, there is a need to proactively educate older adults about brain health. The objective of the Web-Based Brain Health Education Study is to determine the impact of preoperative education on the knowledge of cognitive health of older surgical patients. Specifically, our study will examine the changes in knowledge scores after patients participate in a web-based education program on promoting brain health during their surgical journey. We hypothesize that a web-based education program will increase patient knowledge and empower them proactively about their brain health during the surgical journey.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
164

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2024

Geographic Reach
1 country

2 active sites

Status
recruiting

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

First Submitted

Initial submission to the registry

August 2, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 6, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

August 12, 2024

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2025

Completed
Last Updated

July 8, 2025

Status Verified

June 1, 2025

Enrollment Period

12 months

First QC Date

August 2, 2024

Last Update Submit

July 7, 2025

Conditions

Keywords

Educational ProgramCognitive ImpairmentPostoperative Delirium

Outcome Measures

Primary Outcomes (1)

  • Change in knowledge scores

    A knowledge questionnaire was developed to assess patient's knowledge of brain health during their surgical journey based on our education e-module. Our questionnaire contains 20 True/False questions. Each correct answer is worth one point, giving a minimum value/score of 0 and maximum value/score of 20. Higher values/scores indicate greater knowledge of brain health. The pre- and post-education questionnaires are identical.

    At pre-surgery

Secondary Outcomes (1)

  • Participant satisfaction

    At pre-surgery

Study Arms (1)

web-based education program

EXPERIMENTAL

Older surgical participants will receive a web-based educational program in promoting brain health (intervention). Participants will complete pre- and post-education questionnaires and a post-education satisfaction survey.

Behavioral: Web based education program

Interventions

In a pre-operative assessment, 1-30 days prior to their scheduled surgery, patients will be asked to participate in our web-based educational program. The content of our e-module included: introduction to brain health, surgery, and delirium, causes and risk factors, modifiable risk factors, and delirium prevention. The program will be delivered on a research laptop/iPad at the clinic. The entire program, including pre- and post-education questionnaires and satisfaction survey should take about 20 minutes to complete.

web-based education program

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients ≥60 years old
  • undergoing elective non-cardiac surgery
  • competent to provide informed consent in English and
  • possess some computer skills

You may not qualify if:

  • previous major neurocognitive disorder
  • uncontrolled psychiatric disorders
  • hearing and/or vision impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

399 Bathurst St. Toronto Western Hospital, Preadmission Clinic, Dept. of Anesthesia

Toronto, Ontario, M5T2S8, Canada

RECRUITING

Mount Sinai Hospital

Toronto, Ontario, Canada

RECRUITING

MeSH Terms

Conditions

DementiaCognitive DysfunctionEmergence Delirium

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersCognition DisordersDeliriumConfusionNeurobehavioral ManifestationsNeurologic ManifestationsPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Frances Chung, MBBS, FRCPC

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sazzadul Islam, M.Sc.

CONTACT

Aparna Saripella, M.Sc.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: Single Group Assignment In a pre-operative assessment 1-30 days prior to their scheduled surgery, patients will be asked to participate in our web-based educational program. The program will be delivered on a research laptop/iPad at the clinic. The entire program, including pre- and post-education questionnaires and satisfaction survey should take about 20 minutes to complete.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2024

First Posted

August 6, 2024

Study Start

August 12, 2024

Primary Completion

August 1, 2025

Study Completion

August 30, 2025

Last Updated

July 8, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations