Prevention of Early Postoperative Decline

NCT02908464 | Completed Results FDA Device

• 1 other identifier: 2016P000145
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Delirium; Postoperative Cognitive Dysfunction

Keywords

Cardiac Surgery; Delirium; Postoperative Cognitive Dysfunction

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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.

Other Outcomes (3)

• Postoperative Survey

  Postoperative visit (usually within 1 month after discharge)

• Patient Satisfaction

  Postoperative visit (usually within 1 month after discharge)

• Postoperative Survey (Cont)

  Postoperative visit (usually within 1 month after discharge)

Study Arms (2)

Lumosity (CT Group)

EXPERIMENTAL

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

Usual Care (Control Group)

NO INTERVENTION

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.

Interventions

Lumosity DEVICE

A neurocognitive training program designed to enhance cognitive abilities

Also known as: Brain Games

Lumosity (CT Group)

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients undergoing cardiac surgery age 60-90
• Cardiac surgery scheduled at least 10 days from enrollment
• High school education level or equivalent

You may not qualify if:

• 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

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• Lumos Labs, Inc.: collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

• 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.

  PMID: 30537982 DERIVED

MeSH Terms

Conditions

Delirium; Postoperative Cognitive Complications

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Postoperative Complications; Pathologic Processes; Cognitive Dysfunction; Cognition Disorders

Results Point of Contact

• Title: Brian O'Gara, MD, MPH
• Organization: Beth Israel Deaconess Medical Center

bpogara@bidmc.harvard.edu

617-754-3189

Study Officials

• Brian O'Gara, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: August 30, 2016
• First Posted: September 21, 2016
• Study Start: November 1, 2016
• Primary Completion: January 1, 2019
• Study Completion: September 1, 2019
• Last Updated: June 16, 2020
• Results First Posted: June 16, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)