Columbus, Ohio 43210


Purpose:

Many individuals experience an acute change in thinking and reasoning skills after surgery. This is called post-operative delirium (PD). PD symptoms typically start 1-3 days after surgery. Advanced age has been identified as a risk factor for PD. The purpose of this study is to determine if performing mental exercise, before surgery, will help reduce post-surgery memory and thinking problems. A total of 268 patients will be recruited for this study. At least 10 days before surgery, subjects complete a series of questionnaires to assess baseline cognition level (or thinking ability) and status of overall well-being. At the completion of the screening visit, qualifying subjects are randomized into two groups: Participants randomized into the Cognitive Exercise group are expected to complete tablet-based brain games provided by Lumosity. These subjects are given a handheld tablet for the duration of the preoperative period. Participants in this group are expected to achieve 1 hour of mental training each day for at least 10 consecutive days prior to surgery. Participants randomized into the Normal Activity group are encouraged to carry out their baseline daily activities, and do not have any study-related cognitive exercise expectations before surgery. These subjects still complete the same questionnaires and assessments as the Cognitive Exercise group throughout the study, however, are asked not to alter their normal daily routine of mental exertion (i.e. watching television, reading, puzzles, etc.) and are not permitted to subscribe to Lumosity while in the research study. On the day of surgery, a baseline delirium evaluation (CAM - Confusion Assessment Method) is taken before surgery. During surgery, research personnel monitor vital signs and medications given. After surgery, another CAM evaluation is taken in the post-operative recovery room. Throughout the subject's hospital stay, pain levels and medication usage are recorded. The CAM and MDAS (Memorial Delirium Assessment Scale) are used to identify and determine severity of PD. The evaluations are given twice daily, at approximately 6:00 AM and 6:00 PM, for 7 days or until hospital discharge (whichever comes first). The Postoperative Quality of Recovery Scale (PQRS) is used each post-operative day at 6:00 PM until discharge, and completed over the phone on POD 7 if patient discharged. The PQRS is also administered over the phone on POD 30 and POD 90.


Criteria:

Inclusion Criteria 1. 60 years of age or older 2. Capable and willing to consent 3. Non-cardiac/non-neurological surgery with expected hospital stay of at least 24 H 4. American Society of Anesthesiologists (ASA) physical status I-IV 5. English speaking 6. Willingness to use their home computer/internet or a provided tablet device with internet access 7. Willingness to commit to a minimum of 1 hour a day of cognitive exercise for 10 days prior to surgery Exclusion criteria 1. Severe visual or auditory deficits 2. Illiterate 3. Surgery within the previous 6 months 4. Score < 26 on initial Mini Mental Status Exam (MMSE - modified version) (24 for patients with less than high school education) 5. Score < 18 on initial Self-Administered Gerocognitive Examination (SAGE) 6. Positive pre-surgery Confusion Assessment Method test (CAM) 7. Active depression as indicated by Geriatric Depression Scale screening test 8. History of Axis I or II psychiatric disorders including bipolar disorder, schizophrenia, dementia, alcohol or drug abuse 9. ASA physical status V, VI 10. Planned postoperative intubation


NCT ID:

NCT02230605


Primary Contact:

Principal Investigator
Sergio D Bergese, MD
The Ohio State University Wexner Medical Center

Sergio D Bergese, MD
Phone: 614.293.3559
Email: Sergio.Bergese@osumc.edu


Backup Contact:

Email: Michelle.Humeidan@osumc.edu
Michelle L Humeidan, MD, PhD
Phone: 614.293.3559


Location Contact:

Columbus, Ohio 43210
United States

Sergio D Bergese, MD
Phone: 614-293-3559
Email: Sergio.Bergese@osumc.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 23, 2017

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