Prevention of Early Postoperative Decline

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to determine whether using a brain training program in the time leading up to as well as after heart surgery will reduce confusion and cognitive loss that can occur after surgery.

Detailed Description
-----------------
Randomized, controlled pilot study with a convenience sample of 45 adult cardiac surgical patients. The main intervention to be studied will be the use of a neurocognitive training program (Lumosity) for 10 days preoperatively, and then for four weeks postoperatively. The prescribed regimen of training will focus on the areas of cognitive function most commonly affected in the postoperative period, including working memory, attention, and processing speed. Patients in the control arm will undergo current standard cardiac surgical postoperative care and will be asked to refrain from obtaining a Lumosity account.

Official Title
-----------------
Prevention of Early Postoperative Decline

Conditions
-----------------
Delirium, Postoperative Cognitive Dysfunction

Intervention / Treatment
-----------------
* Device: Lumosity


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients undergoing cardiac surgery age 60-90 Cardiac surgery scheduled at least 10 days from enrollment High school education level or equivalent Exclusion Criteria: Preexisting psychiatric illness History of cerebrovascular event or seizure Non English speakers Baseline severe cognitive dysfunction including Alzheimer's, Parkinson's, or other severe forms of dementia Significant visual impairment Enrollment in another study involving cognition

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lumosity (CT Group)<br>Patients in the Lumosity arm will be prescribed a perioperative neurocognitive training program created in collaboration with Lumos Labs, Inc. The program will contain brain games that focus on enhancing cognitive abilities in working memory, attention, and processing speed. Participants will be expected to complete at least 2, but no more than 3, 15 minute sessions of training per day. The protocol will be prescribed for 10 days preoperatively, and then for four weeks postoperatively. | Device: Lumosity<br>* A neurocognitive training program designed to enhance cognitive abilities<br>* Other names: Brain Games;|
| No Intervention: Usual Care (Control Group)<br>Patients in the usual care arm will undergo current standard of care for cardiac surgery and postoperative recovery. They will be asked to refrain from acquiring a Lumosity account. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of Providing a Neurocognitive Training Program to Elderly Cardiac Surgical Patients - Enrollment | Feasibility will be partly determined by evaluating enrollment. Enrolling >50% of eligible patients is the target. | Enrollment was assessed after enrollment was completed. | 
| Feasibility of Providing a Neurocognitive Training Program to Elderly Cardiac Surgical Patients - Adherence | Feasibility will be partly determined by evaluating adherence patterns. Sufficient adherence to protocol will be deemed sufficient to deem the study feasible. | To be evaluated at the conclusion of the study. Adherence was assessed in 3 separate periods: pre hospital, in hospital, and post discharge (typically at the 4 week follow up clinic visit). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Postoperative Delirium Measured by the Confusion Assessment Method (CAM) | Condition characterized by inattention and fluctuating consciousness. Measured by the Confusion Assessment Method (CAM). Inouye, S., van Dyck, C., Alessi, C., Balkin, S., Siegal, A. & Horwitz, R. (1990). Clarifying confusion: The confusion assessment method. Annals of Internal Medicine, 113(12), 941-948. | Defined as present or absent on any day from postoperative day 1 to postoperative day 7. | 
| Number of Participants With Postoperative Cognitive Decline | Condition characterized by decrease in cognitive performance by one standard deviation after surgery, as compared to baseline. Measured by the Montreal Cognitive Assessment (MoCA). | Day of hospital discharge, an average of 1 week. | 
| Postoperative Cognitive Dysfunction Measured Using the Montreal Cognitive Assessment (MoCA) | Condition characterized by loss of cognitive function after surgery. Measured using the telephonic Montreal Cognitive Assessment (t-MoCA). The minimum score is 0, the maximum score is 22. The higher the score, the better the outcome. | Measured at 1, 3 and 6 months postoperatively. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cardiac Surgery, Delirium, Postoperative Cognitive Dysfunction