Cognitive ImpairmentNCT05653154
Preoperative Survey
An observational study of Cognitive Impairment, run by University Health Network, Toronto at 2 sites in Canada.
Trial summary
This study will examine preoperative concerns in older adults through the use of a self-administered questionnaire. The development of this questionnaire will involve adapting survey questions from previously validated studies, creating new questions, and generating a comprehensive questionnaire. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Cognitive Impairment
- How many people
- 264 participants
- Where
- 2 sitesCanada
- Study dates
- 15 Dec 2022to 23 Oct 2024
- 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: Surgical patients
Who may be able to join
- Older adults, who are aged 65 or older and
- Medical patients in geriatric clinic or surgical inpatients in pre-operative clinics
Who cannot join
- Lack English language capability
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
399 Bathurst St., Toronto Western Hospital, Dept. of Anesthesia
Toronto, Ontario, M5T2S8
Mount Sinai Hospital
Toronto, Ontario
About this study
Official title: Preoperative Concerns in Older Adults
This study will examine preoperative concerns in older adults through the use of a self-administered questionnaire. The development of this questionnaire will involve adapting survey questions from previously validated studies, creating new questions, and generating a comprehensive questionnaire.
Read the detailed description
The primary objective is to assess the preoperative concerns in older adults. This objective will be assessed by using a self-administered questionnaire.
The secondary objective is to examine older adults' attitudes toward preoperative cognitive assessments, functional assessments, and prehabilitation programs. Similarly, this objective will be assessed by using a self-administered questionnaire.
Survey administration will be completed online and in person. Recruited participants will receive an email that contains an external link to the online version of the survey that will be administered on Research Electronic Data Capture (REDCap), an online platform to complete secure surveys. Once received, participants will be able to anonymously complete the survey and not have to provide any identification information except for general sociodemographic variables. Alternatively, study personnel will administer the questionnaire online/ in person at the preoperative clinic to assess surgical population at Mount Sinai Hospital.
- Conditions
- Cognitive Impairment
- Keywords
- Elderly, surgical
- Medical subject headings
- Cognitive Dysfunction
What is being measured
The primary outcome is the main question the study is designed to answer.
preoperative concerns
current daily functional status
Measured: 1 day
Secondary outcomes (1)
Cognitive assessments
Administration of cognitive status questionnaire
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start15 Dec 2022
- Primary completion23 Oct 2024
- Study completion23 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Other
- Enrolment
- 264 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Frances Chung, University Health Network, Toronto
- Investigators
- Frances Chung, MBBS MD FRCPC, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05653154
- Sponsor's protocol ID
- CAPCR # 22-5163
- Status last verified
- Apr 2025
- First submitted
- 29 Nov 2022
- Last updated
- 13 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Concerns in Older Adults
- ClinicalTrials.gov ID
- NCT05653154
- Acronym / sponsor ID
- CAPCR # 22-5163
- Conditions
- Cognitive Impairment
- Keywords
- Elderly, surgical
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 264 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- 23 Oct 2024 (actual)
- Study completion
- 23 Oct 2024 (actual)
- First posted
- 16 Dec 2022 (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.
This study will examine preoperative concerns in older adults through the use of a self-administered questionnaire. The development of this questionnaire will involve adapting survey questions from previously validated studies, creating new questions, and generating a comprehensive questionnaire.
Detailed description
The primary objective is to assess the preoperative concerns in older adults. This objective will be assessed by using a self-administered questionnaire.
The secondary objective is to examine older adults' attitudes toward preoperative cognitive assessments, functional assessments, and prehabilitation programs. Similarly, this objective will be assessed by using a self-administered questionnaire.
Survey administration will be completed online and in person. Recruited participants will receive an email that contains an external link to the online version of the survey that will be administered on Research Electronic Data Capture (REDCap), an online platform to complete secure surveys. Once received, participants will be able to anonymously complete the survey and not have to provide any identification information except for general sociodemographic variables. Alternatively, study personnel will administer the questionnaire online/ in person at the preoperative clinic to assess surgical population at Mount Sinai Hospital.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Surgical patients
Key inclusion criteria (2 listed)
- Older adults, who are aged 65 or older and
- Medical patients in geriatric clinic or surgical inpatients in pre-operative clinics
Key exclusion criteria (1 listed)
- Lack English language capability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
preoperative concerns
Time frame: 1 day
current daily functional status
1 secondary outcome
Cognitive assessments
Time frame: 1 day
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 13 Apr 2025.
- Individual participant dataSharing planned: No
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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.
Frances Chung, MBBS MD FRCPC principal investigator
University Health Network, Toronto
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cognitive Impairment, run by University Health Network, Toronto at 2 sites 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 2 inclusion and 1 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 13 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
preoperative concerns (time frame: 1 day). 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 13 Apr 2025.