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OpenTrials
Completed

NCT Number: NCT02908464

Prevention of Early Postoperative Decline

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.

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Key information

Conditions

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

Age range

60 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lumosity

Device

A neurocognitive training program designed to enhance cognitive abilities

Other names: Brain Games

Primary outcomes

  1. Feasibility of Providing a Neurocognitive Training Program to Elderly Cardiac Surgical Patients - Enrollment

    Time frame: Enrollment was assessed after enrollment was completed.

    Feasibility will be partly determined by evaluating enrollment. Enrolling >50% of eligible patients is the target.

  2. Feasibility of Providing a Neurocognitive Training Program to Elderly Cardiac Surgical Patients - Adherence

    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).

    Feasibility will be partly determined by evaluating adherence patterns. Sufficient adherence to protocol will be deemed sufficient to deem the study feasible.

Secondary outcomes

  1. Number of Participants With Postoperative Delirium Measured by the Confusion Assessment Method (CAM)

    Time frame: Defined as present or absent on any day from postoperative day 1 to postoperative day 7.

    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.

  2. Number of Participants With Postoperative Cognitive Decline

    Time frame: Day of hospital discharge, an average of 1 week.

    Condition characterized by decrease in cognitive performance by one standard deviation after surgery, as compared to baseline. Measured by the Montreal Cognitive Assessment (MoCA).

  3. Postoperative Cognitive Dysfunction Measured Using the Montreal Cognitive Assessment (MoCA)

    Time frame: Measured at 1, 3 and 6 months postoperatively.

    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.

Other outcomes

  1. Postoperative Survey

    Time frame: Postoperative visit (usually within 1 month after discharge)

    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.

  2. Patient Satisfaction

    Time frame: Postoperative visit (usually within 1 month after discharge)

    Overall satisfaction with participating in the study. Measured on a scale of 0-100 with higher values representing higher satisfaction.

  3. Postoperative Survey (Cont)

    Time frame: Postoperative visit (usually within 1 month after discharge)

    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.

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Collaborators

  • Lumos Labs, Inc.

Registry information

Acronym: PEaPoD

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Sep 21, 2016
Registry last updated
Jun 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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