- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06245005
Preoperative Cognitive Reserve in Older Surgical Patients: A Feasibility Study
Investigation of a Novel Quantitative Measure of Preoperative Cognitive Reserve in Older Surgical Patients: A Feasibility Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Potential study participants will be identified by researchers monitoring The Ohio State University Preoperative Assessment Clinic (OPAC) and operating room (OR) schedules. Eligible patients will be contacted over-the-phone regarding willingness to participate. Surgeons will be made aware when their patients have been approached over the phone and updated accordingly if the patient agrees to be enrolled in the study. If willing, patients will be met at either their preoperative assessment at OPAC or their day of surgery at Preoperative Holding. Patients will be screened at this encounter for inclusion and exclusion criteria.
Following the initial screening encounter, patients will be required to provide informed consent prior to any study activities or data collection. Once informed consent is signed by both the subject and researcher, the researcher will provide the patient with a portable electronic device (laptop) with access to Lumosity brain exercise software (Lumos Labs, San Francisco, California, USA) and instruct participants to complete as many of the provided 6 games as possible. These 6 games were identified specifically from preliminary data indicating their postoperative delirium predictive capacity. Gameplay completion and performance scores will be coded and stored on the Lumosity software. Personal health information will not be used on the research device.
At this visit, the researcher will also collect demographic information (age, sex, body max index (BMI), ethnicity, and educational level) and relevant comorbidities via the Charlson Comorbidity Index (CCI). The research device will be collected at the end of the patient's visit at OPAC or just prior to surgery when in preoperative holding.
All patients will undergo surgery as planned. Time under anesthesia and type of surgery will be collected. On the first day following surgery, patients will be assessed by research members for the presence of delirium using the 3-Minute Diagnostic Confusion Assessment Method (3D-CAM) at 0800 ± 2 hours and 1700 ± 2 hours. This will be repeated every postoperative day until postoperative day 7 or discharge, whichever comes first. Additionally, medical notes from the day of surgery to discharge or post-operative day (POD) 7 (whichever comes first) will be assessed for delirium by a researcher using a validated medical chart-based delirium assessment (CHART-DEL). Patients will be asked to complete the Discharge Survey Prior to hospital discharge or over the phone after discharge. In addition, their length of stay in the hospital and discharge location will be collected.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43210
- Recruiting
- The Ohio State University Wexner Medical Center
-
Contact:
- Alberto A Uribe
- Phone Number: 614-293-0775
- Email: alberto.uribe@osumc.edu
-
Contact:
- Jeremy Reeves
- Phone Number: 6142933559
- Email: jeremy.reeves@osumc.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria
- 60 years of age or older
- Capable and willing to consent
- Non-cardiac/non-neurological surgery with an expected hospital stay of at least 72 hours
- Anticipated ASA physical status I-IV
- English speaking
- Willingness to use computer-based device
Exclusion Criteria
- Severe visual or auditory deficits
- Illiterate
- Surgery or procedure within the previous 6 months requiring general anesthesia
- Active Axis I or II psychiatric disorders including bipolar disorder, schizophrenia, dementia, alcohol, or drug abuse
- ASA physical status V, VI
- Planned postoperative ICU admission
- Preoperative benzodiazepine administration (i.e. Midazolam, Diazepam)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
OPAC
Feasibility to conduct brain exercise gameplay on a portable electronic device at Ohio State Preoperative Assessment Clinic (OPAC)
|
Feasibility is defined as a 70% completion rate for at least 3 of the six brain exercise games in study participants from which a 'first gameplay score' can be determined.
Investigators will also assess level of satisfaction with the brain exercise intervention and barriers to playing in the busy preoperative clinical settings as evaluated by a patient-centered questionnaire (Discharge Survey).
|
PREOP
Feasibility to conduct brain exercise gameplay on a portable electronic device at The Wexner Medical Center Preoperative Holding Areas.
|
Feasibility is defined as a 70% completion rate for at least 3 of the six brain exercise games in study participants from which a 'first gameplay score' can be determined.
Investigators will also assess level of satisfaction with the brain exercise intervention and barriers to playing in the busy preoperative clinical settings as evaluated by a patient-centered questionnaire (Discharge Survey).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Lumosity 6-game brain exercise completion
Time Frame: up to 30 minutes after participants start the first Lumosity game brain exercise
|
Determine if brain exercise gameplay on a portable electronic device is feasible in two different preoperative settings (The Ohio State Preoperative Assessment Clinic (OPAC) and The Wexner Medical Center Preoperative Holding Areas).
|
up to 30 minutes after participants start the first Lumosity game brain exercise
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Postoperative Delirium
Time Frame: through study completion, an average of 7 days
|
To assess the incidence of Postoperative Delirium
|
through study completion, an average of 7 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022H0419
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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