- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06540638
Cognitive Health Awareness Program in Surgical Patients
A Web-Based Education Program in Promoting Brain Health During the Surgical Journey in Older Patients
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
The primary objective of this study is to determine the impact of a web-based educational program in promoting brain health in older surgical patients by changes in their knowledge score after education. For the secondary objectives, we aim to 1) determine participant satisfaction with the educational program, and 2) gain insights regarding perceived benefits and drawbacks of the brain health program.
This multicenter study will target older patients from pre-admission clinics at Toronto Western (TWH) and Mount Sinai Hospitals (MSH). Written informed consent to participate in the study will be obtained from all patients in person during the visit.
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/ paper version at the clinic. The entire program, including pre- and post-education questionnaires and satisfaction survey should take about 20 minutes to complete.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada
- Mount Sinai Hospital
-
Toronto, Ontario, Canada, M5T2S8
- 399 Bathurst St. Toronto Western Hospital, Preadmission Clinic, Dept. of Anesthesia
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- patients ≥60 years old
- undergoing elective non-cardiac surgery
- competent to provide informed consent in English and
- possess some computer skills
Exclusion Criteria:
- previous major neurocognitive disorder
- uncontrolled psychiatric disorders
- hearing and/or vision impairment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: web-based education program
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in knowledge scores
Time Frame: At pre-surgery
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Participant satisfaction
Time Frame: At pre-surgery
|
Participants will be asked to rate their level of satisfaction with the educational program.
|
At pre-surgery
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Frances Chung, MBBS, FRCPC, University Health Network, Toronto
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Mental Disorders
- Postoperative Complications
- Pathologic Processes
- Confusion
- Neurobehavioral Manifestations
- Neurocognitive Disorders
- Cognition Disorders
- Delirium
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Emergence Delirium
- Cognitive Dysfunction
- Dementia
Other Study ID Numbers
- 24-5067
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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