Prevention of Early Postoperative Decline (PEaPoD)

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.

Study Overview

• Status: Completed
• Conditions: Delirium; Postoperative Cognitive Dysfunction
• Intervention / Treatment: Device: Lumosity

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 Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lumosity (CT Group); 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; A neurocognitive training program designed to enhance cognitive abilities; Other Names: Brain Games
No Intervention: Usual Care (Control Group); 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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Survey	Satisfaction with CT was assessed postoperatively at the follow up visit. Survey questions were both structured and open-ended. Quantitative scales were used to assess the level of agreement with prompted statements, using slide bars with visible anchors of "strongly disagree" (0), "neutral" (50), and "strongly agree" (100). The final question was only asked of the control patients to gauge their theoretical interest in using cognitive training for a future surgery.	Postoperative visit (usually within 1 month after discharge)
Patient Satisfaction	Overall satisfaction with participating in the study. Measured on a scale of 0-100 with higher values representing higher satisfaction.	Postoperative visit (usually within 1 month after discharge)
Postoperative Survey (Cont)	A final question asked on the postoperative satisfaction survey: Preparation and recovery from cardiac surgery should include some form of brain training program. Results are count of participants answering yes.	Postoperative visit (usually within 1 month after discharge)

Collaborators and Investigators

• Sponsor: Beth Israel Deaconess Medical Center
• Collaborators: Lumos Labs, Inc.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2016
• Primary Completion (Actual): January 1, 2019
• Study Completion (Actual): September 1, 2019

Study Registration Dates

• First Submitted: August 30, 2016
• First Submitted That Met QC Criteria: September 16, 2016
• First Posted (Estimate): September 21, 2016

Study Record Updates

• Last Update Posted (Actual): June 16, 2020
• Last Update Submitted That Met QC Criteria: June 11, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Cardiac Surgery; Delirium; Postoperative Cognitive Dysfunction
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Postoperative Complications; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Cognition Disorders; Delirium; Cognitive Dysfunction; Postoperative Cognitive Complications
• Other Study ID Numbers: 2016P000145

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes