Delirium in Old AgeFOCUSNCT05094817
Feasibility of an Online, Self-administered Cognitive Screening Tool in Older Patients Undergoing Ambulatory Surgery
An observational study of Delirium in Old Age and Alzheimer Disease, run by Women's College Hospital at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Delirium in Old Age, Alzheimer Disease, Mild Cognitive Impairment
- What is being tested?
- Brain Health Assessment, Demographics questionnaire and PHQ-2
- Type of treatment
- Injection or infusion
- How many people
- 78 participants
- Where
- 1 siteCanada
- Study dates
- 11 Feb 2022to 21 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of an Online, Self-administered Cognitive Screening Tool in Older Patients Undergoing Ambulatory Surgery (FOCUS)
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.
Read the detailed description
Older adults (≥60 years of age) are the fastest growing age group in Canada, and by the year 2026, will constitute more than 1 of every 5 Canadians. World-wide, about 703 million people are ≥65 years of age, and this number is projected to double to 1.5 billion in 2050. Higher life expectancy and advancements in anesthetic techniques have led to more older adults with high burdens of co-morbidities to undergo ambulatory surgeries.
Approximately 40-53% of all surgeries performed are on patients >65 years of age. Neurocognitive disorders (NCD) are common in the community with 14-48% of those >age 70 years suffering mild cognitive impairment (MCI).
Impairments in cognitive ability are the most common complications in older adults undergoing major surgery. These impairments include 1) delirium (which may last up to 7 days after surgery), 2) delayed neurocognitive recovery (cognitive decline up to 30 days after surgery) 3) Neurocognitive disorder (postoperative) mild or major (30 days to 12 months after surgery). The decline in executive function, memory, and other cognitive domains may last for weeks to months after surgery. While most patients recover from cognitive impairment, a small minority of patients have persistent impairment. Older adults who are diagnosed with PND have longer hospital length of stay, are less likely to be discharged home, increased health care costs, and a higher incidence of mortality at one year after surgery.
Investigators hypothesize that it is feasible to utilize the BHA to screen for NCDs, and to assess cognitive changes in elderly patients undergoing elective ambulatory surgery.
- Conditions
- Delirium in Old Age, Alzheimer Disease, Mild Cognitive Impairment, Neurocognitive Disorders
- Being tested
- Brain Health Assessment, Demographics questionnaire, PHQ-2, AFT, GAI-SF
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction, Neurocognitive Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain Health AssessmentOther
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.
Demographics questionnaireOther
To compare the sociodemographic characteristics of patients completing Cogniciti's BHA vs. those who are not able to complete the BHA.
PHQ-2Other
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.
AFTOther
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.
GAI-SFOther
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.
pain VASOther
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.
IADLOther
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.
FAM CAMOther
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.
4ATOther
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.
BHA Usability SurveyOther
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.
Clinical Frailty ScaleOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Demographics questionnaire; Other: PHQ-2; Other: AFT; Other: GAI-SF; Other: pain VAS; Other: IADL |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months to 18 months
Secondary outcomes (3)
Usability and acceptability of Cognitici's BHA
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.
Measured: 12 months to 18 months
Percentage of patients who successfully complete Cogniciti's BHA
percentage of enrolled patients who complete all postoperative assessments
Measured: 12 months to 18 months
To estimate the incidence of pre-existing neurocognitive disorders (NCD) in older adults undergoing elective ambulatory surgery.
Identify neurocognitive disorders among older adults undergoing ambulatory surgeries
Measured: 12 months to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2021
- Study start11 Feb 2022
- Primary completion21 Jul 2023
- Study completion21 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delirium in Old AgeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Women's College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University Health Network, Toronto
- Responsible party
- Sponsor
- Investigators
- Jean Wong, MD, Principal investigator, Women's College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05094817
- Sponsor's protocol ID
- 2020-0155-E
- Acronym
- FOCUS
- Status last verified
- Apr 2024
- First submitted
- 5 Jul 2021
- Last updated
- 24 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Publication
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of an Online, Self-administered Cognitive Screening Tool in Older Patients Undergoing Ambulatory Surgery (FOCUS)
- ClinicalTrials.gov ID
- NCT05094817
- Acronym / sponsor ID
- FOCUS / 2020-0155-E
- Conditions
- Delirium in Old Age, Alzheimer Disease, Mild Cognitive Impairment, Neurocognitive Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Women's College HospitalUniversity, hospital or other
- Collaborators
- University Health Network, Toronto
- Study start
- 11 Feb 2022 (actual)
- Primary completion
- 21 Jul 2023 (actual)
- Study completion
- 21 Jul 2023 (actual)
- First posted
- 26 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Older adults (≥60 years of age) are the fastest growing age group in Canada, and by the year 2026, will constitute more than 1 of every 5 Canadians. World-wide, about 703 million people are ≥65 years of age, and this number is projected to double to 1.5 billion in 2050. Higher life expectancy and advancements in anesthetic techniques have led to more older adults with high burdens of co-morbidities to undergo ambulatory surgeries.
Approximately 40-53% of all surgeries performed are on patients >65 years of age. Neurocognitive disorders (NCD) are common in the community with 14-48% of those >age 70 years suffering mild cognitive impairment (MCI).
Impairments in cognitive ability are the most common complications in older adults undergoing major surgery. These impairments include 1) delirium (which may last up to 7 days after surgery), 2) delayed neurocognitive recovery (cognitive decline up to 30 days after surgery) 3) Neurocognitive disorder (postoperative) mild or major (30 days to 12 months after surgery). The decline in executive function, memory, and other cognitive domains may last for weeks to months after surgery. While most patients recover from cognitive impairment, a small minority of patients have persistent impairment. Older adults who are diagnosed with PND have longer hospital length of stay, are less likely to be discharged home, increased health care costs, and a higher incidence of mortality at one year after surgery.
Investigators hypothesize that it is feasible to utilize the BHA to screen for NCDs, and to assess cognitive changes in elderly patients undergoing elective ambulatory surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Access to Computer | – | 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 ScaleParticipants 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. |
| No Access to Computer | – | Other: Demographics questionnaire, Other: PHQ-2, Other: AFT, Other: GAI-SF, Other: pain VAS, Other: IADLSince 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brain Health AssessmentBHA 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. | Other | Access to Computer |
| Demographics questionnaireTo compare the sociodemographic characteristics of patients completing Cogniciti's BHA vs. those who are not able to complete the BHA. | Other | Access to Computer, No Access to Computer |
| PHQ-2PHQ-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. | Other | Access to Computer, No Access to Computer |
| AFTAFT 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. | Other | Access to Computer, No Access to Computer |
| GAI-SFGAI-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. | Other | Access to Computer, No Access to Computer |
| pain VASThe 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. | Other | Access to Computer, No Access to Computer |
| IADLInstrumental 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. | Other | Access to Computer, No Access to Computer |
| FAM CAMFAM-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. | Other | Access to Computer |
| 4ATThe 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. | Other | Access to Computer |
| BHA Usability SurveyThe 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. | Other | Access to Computer |
| Clinical Frailty ScaleCFS 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. | Other | Access to Computer |
Primary outcome
Participants that completed BHA/total participants
Time frame: 12 months to 18 months
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.
3 secondary outcomes
Usability and acceptability of Cognitici's BHA
Time frame: 12 months to 18 months
Percentage of patients who successfully complete Cogniciti's BHA
Time frame: 12 months to 18 months
To estimate the incidence of pre-existing neurocognitive disorders (NCD) in older adults undergoing elective ambulatory surgery.
Time frame: 12 months to 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2024.
- Individual participant dataSharing planned: Undecided. Publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean Wong, MD principal investigator
Women's College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium in Old Age and Alzheimer Disease, run by Women's College Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants that completed BHA/total participants (time frame: 12 months to 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2024.