Prevention of Early Postoperative Decline

NCT ID: NCT02908464

Last Updated: 2020-06-16

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2019-09-30

Brief Summary

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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

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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.

Conditions

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Delirium Postoperative Cognitive Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Lumosity

Intervention Type DEVICE

A neurocognitive training program designed to enhance cognitive abilities

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Lumosity

A neurocognitive training program designed to enhance cognitive abilities

Intervention Type DEVICE

Other Intervention Names

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Brain Games

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lumos Labs, Inc.

INDUSTRY

Sponsor Role collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Brian O'Gara

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Brian O'Gara, MD

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Locations

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Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 30537982 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2016P000145

Identifier Type: -

Identifier Source: org_study_id

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