Remote Cognitive Assessment for Surgical Patients

Mild Cognitive Impairment Clinical Trial

— Remote OR  

Official title:

Remote Evaluation of Cognitive Function for Older Adults Undergoing Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05566275
• Other study ID #: 19-28294P
• Secondary ID: 1RF1AG077557-01
• Status: Recruiting
• Start date: June 29, 2022
• Est. completion date: December 2023

Study information

• Verified date: October 2023
• Source: University of California, San Francisco
• Contact: Amy B. Wise
• Phone: 415-502-5794
• Email: amy.wise[@]ucsf.edu
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 99 Years

Eligibility

Inclusion Criteria:

• Spine surgery with a duration greater than or equal to three hours

• Can speak, write, and understand English

• Ability to participate in remote visit

Exclusion Criteria:

• Participating in other cognitive studies

• Having more than one surgery (planned multiday surgery)

• Emergency surgery

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Delirium
• Mild Cognitive Impairment

Locations

Country	Name	City	State
United States	University of California San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Ely 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. — View Citation

Gaudreau 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Daily after surgery up to discharge from the hospital- an average of days to 2 weeks