Brief Summary

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. Assuming a 30% incidence of PD and proposed 50% reduction of PD in the intervention group (15% incidence), a total of 242 patients (1:1 ratio, 121 in each group) will achieve 80% power to detect 50% reduction using chi-square test at a 5% type I error rate. Assuming approximately 1/3 of consented patients either fail screening or do not complete the study after consent, we expect to consent 358 patients. At least 8 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 complete a minimum of 10 hours within at least 8 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 at 7:30AM ± 1.5 hrs and 6:30PM ± 1.5 hrs, for 7 days or until hospital discharge (whichever comes first). The Postoperative Quality of Recovery Scale (PQRS) is used each post-operative day at 6:30PM ± 1.5 hrs 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

322

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started Jul 2015

Longer than P75 for not_applicable

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

4.1 years study duration

First Submitted

Initial submission to the registry

August 29, 2014

Completed

5 days until next milestone

First Posted

Study publicly available on registry

September 3, 2014

Completed

10 months until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed

3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2019

Completed

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2019

Completed

Last Updated

September 11, 2019

Status Verified

September 1, 2019

Enrollment Period

3.9 years

First QC Date

August 29, 2014

Last Update Submit

September 10, 2019

Conditions

Delirium

Keywords

DeliriumPost Operative DeliriumPDPODAnesthesiaAnesthesiologyPost Operative RecoveryPost Anesthesia Care UnitPACUCognitionCognitive ImpairmentMemoryThinkingConfusion Assessment MethodCAMNeurobicsNeuroplasticityLumosityBrain GamesCognitive ExerciseCognitive TrainingPerioperative Cognitive ProtectionCognitive ReserveNeurobics TrialSurgeryElderly Patients

Outcome Measures

Primary Outcomes (1)

Reduction in the incidence of Post-Operative Delirium (%)
Assuming a 30% incidence of PD and proposed 50% reduction of PD in the intervention group (15% incidence), a total of 242 patients (1:1 ratio, 121 in each group) will achieve 80% power to detect 50% reduction using chi-square test at a 5% type I error rate. Assuming approximately 1/3 of consented patients either fail screening or do not complete the study after consent, we expect to consent 358 patients. The incidence of PD will be compared between the control group and the intervention group as detected by the Confusion Assessment Method (CAM) / Memorial Delirium Assessment Scale (MDAS). Once a patient is positive, they will no longer be assessed.
Post-Operative Period (Day 0 through Day 7 or Discharge, whichever comes first)

Study Arms (2)

Cognitive Exercise

EXPERIMENTAL

The cognitive exercises will consist of a series of computer games focusing on five categories: memory, speed, attention, flexibility and problem-solving. Participants will be expected to complete 1 hour of Lumosity exercise daily for a minimum of 8 days prior to surgery. Participants will be instructed to complete no less than 15 minutes of exercise at a time throughout each day. Each hour of exercise, participants will work through at least 1 game under each category. Research assessments will include Mini-Mental State Examination, Self-Administered Gerocognitive Examination, Geriatric Depression Scale, Charlson Comorbidity Index, Short Form 36 Health Survey, Confusion Assessment Method, Memorial Delirium Assessment Scale and Postoperative Quality of Recovery Scale.

Other: Mini-Mental State ExaminationOther: Self-Administered Gerocognitive ExaminationOther: Geriatric Depression ScaleOther: Charlson Comorbidity IndexOther: Short Form 36 Health SurveyOther: Confusion Assessment MethodOther: Memorial Delirium Assessment ScaleOther: Postoperative Quality of Recovery Scale

Normal Activity

PLACEBO COMPARATOR

Participants randomized into the Normal Activity group will be encouraged to maintain their normal activity level prior to surgery. These participants are asked not to alter their normal daily routine of mental exertion (i.e. watching television, reading, puzzles, etc.) and not permitted to subscribe to Lumosity while in the research study. Research assessments will include Mini-Mental State Examination, Self-Administered Gerocognitive Examination, Geriatric Depression Scale, Charlson Comorbidity Index, Short Form 36 Health Survey, Confusion Assessment Method, Memorial Delirium Assessment Scale and Postoperative Quality of Recovery Scale.