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Prevention of Early Postoperative Decline (PEaPoD)

Primary Purpose

Delirium, Postoperative Cognitive Dysfunction

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lumosity
Sponsored by
Beth Israel Deaconess Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Delirium focused on measuring Cardiac Surgery, Delirium, Postoperative Cognitive Dysfunction

Eligibility Criteria

60 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Beth Israel Deaconess Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Lumosity (CT Group)

Usual Care (Control Group)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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).
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.

Full Information

First Posted
August 30, 2016
Last Updated
June 11, 2020
Sponsor
Beth Israel Deaconess Medical Center
Collaborators
Lumos Labs, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02908464
Brief Title
Prevention of Early Postoperative Decline
Acronym
PEaPoD
Official Title
Prevention of Early Postoperative Decline
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
November 2016 (undefined)
Primary Completion Date
January 2019 (Actual)
Study Completion Date
September 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center
Collaborators
Lumos Labs, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium, Postoperative Cognitive Dysfunction
Keywords
Cardiac Surgery, Delirium, Postoperative Cognitive Dysfunction

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lumosity (CT Group)
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual Care (Control Group)
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Lumosity
Other Intervention Name(s)
Brain Games
Intervention Description
A neurocognitive training program designed to enhance cognitive abilities
Primary Outcome Measure Information:
Title
Feasibility of Providing a Neurocognitive Training Program to Elderly Cardiac Surgical Patients - Enrollment
Description
Feasibility will be partly determined by evaluating enrollment. Enrolling >50% of eligible patients is the target.
Time Frame
Enrollment was assessed after enrollment was completed.
Title
Feasibility of Providing a Neurocognitive Training Program to Elderly Cardiac Surgical Patients - Adherence
Description
Feasibility will be partly determined by evaluating adherence patterns. Sufficient adherence to protocol will be deemed sufficient to deem the study feasible.
Time Frame
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 Measure Information:
Title
Number of Participants With Postoperative Delirium Measured by the Confusion Assessment Method (CAM)
Description
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.
Time Frame
Defined as present or absent on any day from postoperative day 1 to postoperative day 7.
Title
Number of Participants With Postoperative Cognitive Decline
Description
Condition characterized by decrease in cognitive performance by one standard deviation after surgery, as compared to baseline. Measured by the Montreal Cognitive Assessment (MoCA).
Time Frame
Day of hospital discharge, an average of 1 week.
Title
Postoperative Cognitive Dysfunction Measured Using the Montreal Cognitive Assessment (MoCA)
Description
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.
Time Frame
Measured at 1, 3 and 6 months postoperatively.
Other Pre-specified Outcome Measures:
Title
Postoperative Survey
Description
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.
Time Frame
Postoperative visit (usually within 1 month after discharge)
Title
Patient Satisfaction
Description
Overall satisfaction with participating in the study. Measured on a scale of 0-100 with higher values representing higher satisfaction.
Time Frame
Postoperative visit (usually within 1 month after discharge)
Title
Postoperative Survey (Cont)
Description
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.
Time Frame
Postoperative visit (usually within 1 month after discharge)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian O'Gara, MD
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30537982
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.
Results Reference
derived

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Prevention of Early Postoperative Decline

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