Prevention of Early Postoperative Decline
- Conditions
- Postoperative Cognitive DysfunctionDelirium
- Interventions
- Device: Lumosity
- Registration Number
- NCT02908464
- Lead Sponsor
- Beth Israel Deaconess Medical Center
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 45
- Adult patients undergoing cardiac surgery age 60-90
- Cardiac surgery scheduled at least 10 days from enrollment
- High school education level or equivalent
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lumosity (CT Group) Lumosity 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.
- Primary Outcome Measures
Name Time Method Feasibility of Providing a Neurocognitive Training Program to Elderly Cardiac Surgical Patients - Enrollment 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 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 Outcome Measures
Name Time Method 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. 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.Number of Participants With Postoperative Cognitive Decline Day of hospital discharge, an average of 1 week. Condition characterized by decrease in cognitive performance by one standard deviation after surgery, as compared to baseline. Measured by the Montreal Cognitive Assessment (MoCA).
Postoperative Cognitive Dysfunction Measured Using the Montreal Cognitive Assessment (MoCA) Measured at 1, 3 and 6 months postoperatively. 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.
Trial Locations
- Locations (1)
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States