Feasibility of an Online, Self-administered Cognitive Screening Tool in Older Patients Undergoing Ambulatory Surgery

NCT05094817 | Completed

• 1 other identifier: 2020-0155-E
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

Delirium is common in older adults after inpatient surgery and may be associated with cognitive decline. Advances in surgical and anesthetic techniques have led to increasing numbers of older adults undergoing surgery on an outpatient basis. However, few studies have investigated cognitive disorders of older adults before or after ambulatory surgery. Increased age and pre-existing cognitive impairment are strong risk factors for cognitive decline after surgery, yet older adults are not screened for cognitive impairment before surgery. Existing screening tools require specially trained staff for test administration and in-person testing. Virtual cognitive screening has not been evaluated in surgical patients. In this study, investigators will determine the feasibility of using Cogniciti's Brain Health Assessment (BHA) - a validated online cognitive screening tool that can be self-administered from a patient's home before surgery - to screen older adults before ambulatory surgery.

Conditions

Delirium in Old Age; Alzheimer Disease; Mild Cognitive Impairment; Neurocognitive Disorders

Outcome Measures

Primary Outcomes (1)

• Participants that completed BHA/total participants

  To determine the feasibility (recruitment capability, rates of completion, resulting sociodemographic characteristics) of using a self-administered cognitive assessment tool (Cogniciti's BHA) in older adults undergoing elective ambulatory surgery.

  12 months to 18 months

Secondary Outcomes (3)

• Usability and acceptability of Cognitici's BHA

  12 months to 18 months

• Percentage of patients who successfully complete Cogniciti's BHA

  12 months to 18 months

• To estimate the incidence of pre-existing neurocognitive disorders (NCD) in older adults undergoing elective ambulatory surgery.

  12 months to 18 months

Other Outcomes (1)

• The sociodemographic characteristics of patients completing Cogniciti's BHA vs. those who that do not.

  12 months to 18 months

Study Arms (2)

Access to Computer

Participants completing the BHA should be at least somewhat comfortable or very comfortable with using a computer and mouse and should use a computer at least once a week.

Other: Brain Health Assessment; Other: Demographics questionnaire; Other: PHQ-2; Other: AFT; Other: GAI-SF; Other: pain VAS; Other: IADL; Other: FAM CAM; Other: 4AT; Other: BHA Usability Survey; Other: Clinical Frailty Scale

No Access to Computer

Since participants in previous studies on cognitive screening are usually more educated individuals with higher income, participants who do not have proficiency/or access to a computer will be asked to complete some questionnaires to determine any sociodemographic or baseline differences between patients who are able to complete BHA vs. those who are not able to complete BHA.

Other: Demographics questionnaire; Other: PHQ-2; Other: AFT; Other: GAI-SF; Other: pain VAS; Other: IADL

Interventions

Brain Health Assessment OTHER

BHA is a free, self-administered online cognitive screening test developed in Toronto at Baycrest (www.cogniciti.com). BHA has been validated against a gold standard neuropsychological assessment for detecting amnestic MCI (aMCI) - the most common type of MCI - in community dwelling older adults. BHA has high sensitivity (.78), specificity (.78), PPV (.82), NPV (.74), and was better than MoCA for identifying aMCI. ROC curves showed an AUC of 0.75 for detecting aMCI from normal subjects. BHA measures memory and executive attention processes sensitive to subtle cognitive changes associated with normal aging and MCI. BHA can be completed from a patient's home or can be self-administered in hospital.

Access to Computer

Demographics questionnaire OTHER

To compare the sociodemographic characteristics of patients completing Cogniciti's BHA vs. those who are not able to complete the BHA.

Access to Computer; No Access to Computer

PHQ-2 OTHER

PHQ-2 is a shortened version of PHQ-9 which is originally a component of the longer Patient Health Questionnaire. The tool incorporates DSM-IV depression criteria and other leading major depressive symptoms into brief self-reported instruments. PHQ-2 inquires about the degree to which an individual experiences depression and anhedonia (inability to feel pleasure) over the past two weeks. The tool is not for final diagnosis of depression or monitoring its severity but only for the purpose of screening for the condition.The questionnaire comprises of the first two questions from PHQ-9, each item is scored 0-3. Therefore, the PHQ-2 score ranges from 0-6.

Access to Computer; No Access to Computer

AFT OTHER

AFT is a free, rapid cognitive assessment commonly used to assess semantic language ability. Language is one of the earliest functions affected by AD and naming and semantical knowledge seems to be particularly affected. The identification of language deficits may pick up signs of neurological decline preceding the appearance of clinical symptoms. Milder forms of cognitive impairment such as MCI may also show language deficits if language is one of the domains affected.

Access to Computer; No Access to Computer

GAI-SF OTHER

GAI-SF is a 5-item questionnaire derived from the original 20-item Geriatric Anxiety Inventory (GAI).In the population of community dwelling older women GAI-SF was developed in, a cut-off score of 3 yields a specificity of 87% and sensitivity of 75%. This highly accessible questionnaire is suitable for everyday use in a range of health-care settings. It has been employed amongst older adults in primary care settings, nursing homes, geriatric psychiatry patients and amongst clinical geriatric participants with co-morbid anxiety and unipolar mood disorder and their controls.

Access to Computer; No Access to Computer

pain VAS OTHER

The VAS is a unidimensional measure of pain intensity. The VAS tries to measure a continuous characteristic or attitude signifying the intensity or frequency of symptoms. The scale ranges from 0-10, with 0 = no pain to 10 = worst pain.

Access to Computer; No Access to Computer

IADL OTHER

Instrumental activities such as preparing meals or managing finances allow individuals to maintain their health while living on their own. The IADL measures the ability of older adults to manage their daily activities, as well as the impact, if any, cognitive decline would have on these activities. Scores range from 0-5 for men, and 0-8 for women, with higher sores being more independent and higher functioning.

Access to Computer; No Access to Computer

FAM CAM OTHER

FAM-CAM was derived from the CAM instrument in order to screen for delirium by interviewing family members or caregivers of the patient. They are asked specific questions about any new or sudden changes in the patient's activity, behavioural or cognitive status. FAM-CAM showed good sensitivity and specificity in the original study where caregivers of elderly patients with pre-existing cognitive impairment were interviewed.

Access to Computer

4AT OTHER

The 4AT is a rapid tool for delirium detection that has previously been used in a surgical setting. The 4Ats test for the patient's alertness, mental state, attention, and signs of acute change. Across 17 studies, the pooled sensitivity and specificity of 4AT was 0.86 and 0.89. The 4AT will be administered after the patient has completed surgery, prior to discharge.

Access to Computer

BHA Usability Survey OTHER

The survey aims to assess system usability and acceptability based on standard questions adapted from the validated System Usability Scale. The questions evaluate satisfaction, experience with technology, and comfort level, as well as questions targeting usability concerns typically experienced by older adults, such as typeface and font size, consistent navigation, and writing style.

Access to Computer

Clinical Frailty Scale OTHER

CFS is a 9-item scale that uses clinical descriptors and pictographs and is an easily applicable tool to stratify older adults according to level of vulnerability. The CFS divides patients into 9 classes from very fit (CFS = 1) to terminally ill (CFS = 9). It is easy to use and may readily be administered in a clinical setting, an advantage over the tools previously developed. The scale helps in objective early identification of older adults with frailty in acute care units and helps to target interventions to prevent complications and to implement effective discharge planning.

Access to Computer

Eligibility Criteria

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

Study Population

Elderly patients ≥65 years old from pre-operative clinics at WCH and TWH will be approached. Research personnel will identify participants that meet the inclusion criteria and informed consent will be obtained from eligible participants.

You may qualify if:

• Adults (≥65 years old)
• Undergoing elective ambulatory surgery
• Participants must be competent to provide informed consent,
• Be proficient in English (Grade 6 reading level)
• Have cognitive, visual, and physical capability necessary to complete the questionnaires and/or online assessment tool.
• Participants completing the BHA should be at least somewhat comfortable or very comfortable with using a computer and mouse and should use a computer at least once a week.

You may not qualify if:

• Inability to speak, read or understand English
• Previous intracranial surgery
• A previous diagnosis of major NCD e.g. dementia, and current significant uncontrolled psychiatric disorders.

Sponsors & Collaborators

• Women's College Hospital: lead
• University Health Network, Toronto: collaborator

Study Sites (1)

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

Location

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction; Neurocognitive Disorders

Interventions

Patient Health Questionnaire

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Mental Disorders; Cognition Disorders

Intervention Hierarchy (Ancestors)

Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Psychological Tests; Behavioral Disciplines and Activities; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Jean Wong, MD

  Women's College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 5, 2021
• First Posted: October 26, 2021
• Study Start: February 11, 2022
• Primary Completion: July 21, 2023
• Study Completion: July 21, 2023
• Last Updated: April 24, 2024

Record last verified: 2024-04

Locations

CA (1)