Mild Cognitive ImpairmentRemote ORNCT05566275
Remote Cognitive Assessment for Surgical Patients
An observational study of Mild Cognitive Impairment and Delirium, run by University of California, San Francisco at 1 site in United States.
Trial summary
This is a pilot study to evaluate the use of remote cognitive testing to identify patients who may have cognitive vulnerability and may benefit from cognitive care pathways. Participants in this study are asked to complete a smartphone battery of thinking, memory, speech, and motor function tests on their smartphone. Read more about this study
- Who is it for?
- Ages 65 to 99 years
- Conditions the study is for
- Mild Cognitive Impairment, Delirium
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jun 2022to 29 Feb 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 to 99 years
- All sexes
- No healthy volunteers
- Older adult
Study population: Adults undergoing surgery
Who may be able to join
- Spine surgery with a duration greater than or equal to three hours
- Can speak, write, and understand English
- Ability to participate in remote visit
Who cannot join
- Participating in other cognitive studies
- Having more than one surgery (planned multiday surgery)
- Emergency surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Francisco
San Francisco, California, 94158
About this study
Official title: Remote Evaluation of Cognitive Function for Older Adults Undergoing Surgery
This is a pilot study to evaluate the use of remote cognitive testing to identify patients who may have cognitive vulnerability and may benefit from cognitive care pathways. Participants in this study are asked to complete a smartphone battery of thinking, memory, speech, and motor function tests on their smartphone.
Read the detailed description
This study is evaluating cognitive function in older adults that are undergoing surgery using remote assessments. Participants complete a battery of neuropsychological assessments prior to their surgery date. The battery includes smartphone adaptions of tests of thinking, memory, speech, and movement. The participant has a one-hour remote visit, where the investigators will conduct a Montreal Cognitive Assessment (MoCA) and have the participant complete the smartphone assessments. After their surgery, participants are evaluated on the delirium rating scale.
- Conditions
- Mild Cognitive Impairment, Delirium
- Keywords
- Remote Cognitive Assessment
- Medical subject headings
- Cognitive Dysfunction, Delirium
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients that develop Postoperative Delirium (POD).
Postoperative Delirium is measured by clinical assessment using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU), or the Nursing Delirium Screen Scale (Nu-DESC). A composite delirium score is calculated, and patient is included in the delirium group if either CAM-ICU or NuDESC screenings are positive during the hospital stay. Electronic medical records will also be evaluated for any delirium diagnosis.
Measured: Daily after surgery up to discharge from the hospital- an average of days to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2022
- Study start29 Jun 2022
- Primary completion29 Feb 2024
- Study completion29 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Adam Staffaroni, PhD, Principal investigator, University of California, San FranciscoOdmara Barreto Chang, MD, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05566275
- Sponsor's protocol ID
- 19-28294P
- Other IDs
- 1RF1AG077557-01
- Acronym
- Remote OR
- Status last verified
- Nov 2025
- First submitted
- 28 Sep 2022
- Last updated
- 12 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators will not make individual participant data available to other researchers.
Publications
Staffaroni AM, Tsoy E, Taylor J, Boxer AL, Possin KL. Digital Cognitive Assessments for Dementia: Digital assessments may enhance the efficiency of evaluations in neurology and other clinics. Pract Neurol (Fort Wash Pa). 2020 Nov-Dec;2020:24-45. No abstract available.
PubMed 33927583Gaudreau JD, Gagnon P, Harel F, Tremblay A, Roy MA. Fast, systematic, and continuous delirium assessment in hospitalized patients: the nursing delirium screening scale. J Pain Symptom Manage. 2005 Apr;29(4):368-75. doi: 10.1016/j.jpainsymman.2004.07.009.
PubMed 15857740Ely EW, Inouye SK, Bernard GR, Gordon S, Francis J, May L, Truman B, Speroff T, Gautam S, Margolin R, Hart RP, Dittus R. Delirium in mechanically ventilated patients: validity and reliability of the confusion assessment method for the intensive care unit (CAM-ICU). JAMA. 2001 Dec 5;286(21):2703-10. doi: 10.1001/jama.286.21.2703.
PubMed 11730446Barreto Chang OL, Wise AB, Sinha A, Possin KL, Boxer A, Staffaroni AM; Collaborators. Remote Cognitive Testing for Detection of Baseline Cognitive Impairment and Prediction of Postoperative Delirium Risk: A Pilot Study. Anesth Analg. 2026 Jun 1;142(6):1229-1231. doi: 10.1213/ANE.0000000000007843. Epub 2026 May 19. No abstract available.
PubMed 41359772
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Evaluation of Cognitive Function for Older Adults Undergoing Surgery
- ClinicalTrials.gov ID
- NCT05566275
- Acronym / sponsor ID
- Remote OR / 19-28294P
- Conditions
- Mild Cognitive Impairment, Delirium
- Keywords
- Remote Cognitive Assessment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 29 Jun 2022 (actual)
- Primary completion
- 29 Feb 2024 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 4 Oct 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 is a pilot study to evaluate the use of remote cognitive testing to identify patients who may have cognitive vulnerability and may benefit from cognitive care pathways. Participants in this study are asked to complete a smartphone battery of thinking, memory, speech, and motor function tests on their smartphone.
Detailed description
This study is evaluating cognitive function in older adults that are undergoing surgery using remote assessments. Participants complete a battery of neuropsychological assessments prior to their surgery date. The battery includes smartphone adaptions of tests of thinking, memory, speech, and movement. The participant has a one-hour remote visit, where the investigators will conduct a Montreal Cognitive Assessment (MoCA) and have the participant complete the smartphone assessments. After their surgery, participants are evaluated on the delirium rating scale.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 65 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Adults undergoing surgery
Key inclusion criteria (3 listed)
- Spine surgery with a duration greater than or equal to three hours
- Can speak, write, and understand English
- Ability to participate in remote visit
Key exclusion criteria (3 listed)
- Participating in other cognitive studies
- Having more than one surgery (planned multiday surgery)
- Emergency surgery
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
Number of Patients that develop Postoperative Delirium (POD).
Time frame: Daily after surgery up to discharge from the hospital- an average of days to 2 weeks
Postoperative Delirium is measured by clinical assessment using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU), or the Nursing Delirium Screen Scale (Nu-DESC). A composite delirium score is calculated, and patient is included in the delirium group if either CAM-ICU or NuDESC screenings are positive during the hospital stay. Electronic medical records will also be evaluated for any delirium diagnosis.
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 12 Nov 2025.
- Background: PubMed 33927583Staffaroni AM, Tsoy E, Taylor J, Boxer AL, Possin KL. Digital Cognitive Assessments for Dementia: Digital assessments may enhance the efficiency of evaluations in neurology and other clinics. Pract Neurol (Fort Wash Pa). 2020 Nov-Dec;2020:24-45. No abstract available.
- Background: PubMed 15857740Gaudreau JD, Gagnon P, Harel F, Tremblay A, Roy MA. Fast, systematic, and continuous delirium assessment in hospitalized patients: the nursing delirium screening scale. J Pain Symptom Manage. 2005 Apr;29(4):368-75. doi: 10.1016/j.jpainsymman.2004.07.009.
- Background: PubMed 11730446Ely EW, Inouye SK, Bernard GR, Gordon S, Francis J, May L, Truman B, Speroff T, Gautam S, Margolin R, Hart RP, Dittus R. Delirium in mechanically ventilated patients: validity and reliability of the confusion assessment method for the intensive care unit (CAM-ICU). JAMA. 2001 Dec 5;286(21):2703-10. doi: 10.1001/jama.286.21.2703.
- Derived from this study: PubMed 41359772Barreto Chang OL, Wise AB, Sinha A, Possin KL, Boxer A, Staffaroni AM; Collaborators. Remote Cognitive Testing for Detection of Baseline Cognitive Impairment and Prediction of Postoperative Delirium Risk: A Pilot Study. Anesth Analg. 2026 Jun 1;142(6):1229-1231. doi: 10.1213/ANE.0000000000007843. Epub 2026 May 19. No abstract available.
- Individual participant dataSharing planned: No. The investigators will not make individual participant data available to other researchers.
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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.
Adam Staffaroni, PhD principal investigator
University of California, San Francisco
Odmara Barreto Chang, MD, PhD principal investigator
University of California, San Francisco
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 Mild Cognitive Impairment and Delirium, run by University of California, San Francisco at 1 site in United States.
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 3 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 12 Nov 2025. 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 United States. 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?
Number of Patients that develop Postoperative Delirium (POD). (time frame: Daily after surgery up to discharge from the hospital- an average of days to 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05566275, which also lists 4 linked publications.
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 12 Nov 2025.