Prevention of Early Postoperative Decline

Beth Israel Deaconess Medical Center45 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Delirium Postoperative Cognitive Dysfunction

Interventions

LumosityDEVICE

A neurocognitive training program designed to enhance cognitive abilities

Eligibility

Sex: ALLMin age: 60 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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 Outcomes

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.

Time frame: 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).

Time frame: 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.

Data from ClinicalTrials.gov

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