Clinical trial NCT02908464: Prevention of Early Postoperative Decline
Official title: Prevention of Early Postoperative Decline
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Delirium
Postoperative Cognitive Dysfunction
Keywords: Cardiac Surgery
Delirium
Postoperative Cognitive Dysfunction
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: Lumos Labs, Inc.
First posted: 2016-09-21
Enrollment: 45
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Feasibility of Providing a Neurocognitive Training Program to Elderly Cardiac Surgical Patients - Enrollment
timeFrame: Enrollment was assessed after enrollment was completed.
measure: Feasibility of Providing a Neurocognitive Training Program to Elderly Cardiac Surgical Patients - Adherence
timeFrame: 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:
measure: Number of Participants With Postoperative Delirium Measured by the Confusion Assessment Method (CAM)
timeFrame: Defined as present or absent on any day from postoperative day 1 to postoperative day 7.
measure: Number of Participants With Postoperative Cognitive Decline
timeFrame: Day of hospital discharge, an average of 1 week.
measure: Postoperative Cognitive Dysfunction Measured Using the Montreal Cognitive Assessment (MoCA)
timeFrame: Measured at 1, 3 and 6 months postoperatively.
Other outcomes:
measure: Postoperative Survey
timeFrame: Postoperative visit (usually within 1 month after discharge)
measure: Patient Satisfaction
timeFrame: Postoperative visit (usually within 1 month after discharge)
measure: Postoperative Survey (Cont)
timeFrame: Postoperative visit (usually within 1 month after discharge)
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Brian O'Gara, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: O'Gara B, Marcantonio ER, Pascual-Leone A, Shaefi S, Mueller A, Banner-Goodspeed V, Talmor D, Subramaniam B. Prevention of Early Postoperative Decline (PEaPoD): protocol for a randomized, controlled feasibility trial. Trials. 2018 Dec 11;19(1):676. doi: 10.1186/s13063-018-3063-z.