Prevention of Early Postoperative Decline
Overview
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 45
- Locations
- 1
- Primary Endpoint
- Feasibility of Providing a Neurocognitive Training Program to Elderly Cardiac Surgical Patients - Enrollment
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 60 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Feasibility of Providing a Neurocognitive Training Program to Elderly Cardiac Surgical Patients - Enrollment
Time Frame: Enrollment was assessed after enrollment was completed.
Feasibility will be partly determined by evaluating enrollment. Enrolling \>50% of eligible patients is the target.
Feasibility of Providing a Neurocognitive Training Program to Elderly Cardiac Surgical Patients - Adherence
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).
Feasibility will be partly determined by evaluating adherence patterns. Sufficient adherence to protocol will be deemed sufficient to deem the study feasible.
Secondary Outcomes
- Number of Participants With Postoperative Delirium Measured by the Confusion Assessment Method (CAM)(Defined as present or absent on any day from postoperative day 1 to postoperative day 7.)
- Number of Participants With Postoperative Cognitive Decline(Day of hospital discharge, an average of 1 week.)
- Postoperative Cognitive Dysfunction Measured Using the Montreal Cognitive Assessment (MoCA)(Measured at 1, 3 and 6 months postoperatively.)
Investigators
Brian O'Gara
MD
Beth Israel Deaconess Medical Center