Prevention of Early Postoperative Decline

Delirium Clinical Trial

— PEaPoD  

Official title:

Prevention of Early Postoperative Decline

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02908464
• Other study ID #: 2016P000145
• Status: Completed
• Phase: N/A
• Start date: November 2016
• Est. completion date: September 2019

Study information

• Verified date: June 2020
• Source: Beth Israel Deaconess Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: September 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Delirium
• Postoperative Cognitive Dysfunction

Intervention

Device:
• Lumosity
A neurocognitive training program designed to enhance cognitive abilities

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	Lumos Labs, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	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)
Other	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)
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.