Trial Outcomes & Findings for Prevention of Early Postoperative Decline (NCT NCT02908464)
NCT ID: NCT02908464
Last Updated: 2020-06-16
Results Overview
Feasibility will be partly determined by evaluating enrollment. Enrolling \>50% of eligible patients is the target.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
45 participants
Primary outcome timeframe
Enrollment was assessed after enrollment was completed.
Results posted on
2020-06-16
Participant Flow
After participant enrollment, a baseline cognitive assessment was performed using the Montreal Cognitive Assessment (MoCA). If the patient achieved a score indicating the presence of severe baseline cognitive impairment (\<10), they were subsequently withdrawn.
Participant milestones
| Measure |
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.
Lumosity: 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.
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
23
|
|
Overall Study
COMPLETED
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
| Measure |
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.
Lumosity: 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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
|
Overall Study
Found ineligible after randomization
|
0
|
2
|
Baseline Characteristics
Prevention of Early Postoperative Decline
Baseline characteristics by cohort
| Measure |
Lumosity (CT Group)
n=20 Participants
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.
Lumosity: A neurocognitive training program designed to enhance cognitive abilities
|
Usual Care (Control Group)
n=20 Participants
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.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
70 years
STANDARD_DEVIATION 6 • n=5 Participants
|
69 years
STANDARD_DEVIATION 7 • n=7 Participants
|
70 years
STANDARD_DEVIATION 4.5 • n=5 Participants
|
|
Sex/Gender, Customized
Male
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · White
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · American Indian or Alaskan Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Multi-Racial
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Unknown
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race/Ethnicity · Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
40 participants
n=5 Participants
|
|
Language Status
Native born English speaker
|
17 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Language Status
Foreign born, English is second language
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Education Level
High school graduate or equivalent
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Education Level
Some college, associate's degree
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Education Level
Bachelor's degree
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Education Level
Master's degree
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Education Level
Doctoral degree
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Enrollment was assessed after enrollment was completed.Population: This population is of patients who after screening met the eligibility criteria and were approached for this study. The total count of participants depict the total number enrolled.
Feasibility will be partly determined by evaluating enrollment. Enrolling \>50% of eligible patients is the target.
Outcome measures
| Measure |
Overall Study Enrollment
n=69 Participants
This group includes the enrollment of patients in the Lumosity arm (CT Group), as well as the patients in the usual care arm (Control Group).
|
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.
|
|---|---|---|
|
Feasibility of Providing a Neurocognitive Training Program to Elderly Cardiac Surgical Patients - Enrollment
|
45 Participants
|
—
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Overall Study Enrollment
n=20 Participants
This group includes the enrollment of patients in the Lumosity arm (CT Group), as well as the patients in the usual care arm (Control Group).
|
Usual Care (Control Group)
n=20 Participants
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.
|
|---|---|---|
|
Feasibility of Providing a Neurocognitive Training Program to Elderly Cardiac Surgical Patients - Adherence
Pre-Hospital Training Adherence
|
39 percentage of minutes trained/prescribed
Interval 20.0 to 68.0
|
0 percentage of minutes trained/prescribed
Interval 0.0 to 0.0
|
|
Feasibility of Providing a Neurocognitive Training Program to Elderly Cardiac Surgical Patients - Adherence
In-Hospital Training Adherence
|
6 percentage of minutes trained/prescribed
Interval 0.0 to 37.0
|
0 percentage of minutes trained/prescribed
Interval 0.0 to 0.0
|
|
Feasibility of Providing a Neurocognitive Training Program to Elderly Cardiac Surgical Patients - Adherence
Post-Discharge Training Adherence
|
19 percentage of minutes trained/prescribed
Interval 0.0 to 56.0
|
0 percentage of minutes trained/prescribed
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Overall Study Enrollment
n=20 Participants
This group includes the enrollment of patients in the Lumosity arm (CT Group), as well as the patients in the usual care arm (Control Group).
|
Usual Care (Control Group)
n=20 Participants
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.
|
|---|---|---|
|
Number of Participants With Postoperative Delirium Measured by the Confusion Assessment Method (CAM)
Delrium present
|
5 Participants
|
3 Participants
|
|
Number of Participants With Postoperative Delirium Measured by the Confusion Assessment Method (CAM)
Delirium not present
|
15 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: Day of hospital discharge, an average of 1 week.Population: The discrepancy of participants analyzed comes from missed assessments due to unavailability of study staff.
Condition characterized by decrease in cognitive performance by one standard deviation after surgery, as compared to baseline. Measured by the Montreal Cognitive Assessment (MoCA).
Outcome measures
| Measure |
Overall Study Enrollment
n=17 Participants
This group includes the enrollment of patients in the Lumosity arm (CT Group), as well as the patients in the usual care arm (Control Group).
|
Usual Care (Control Group)
n=19 Participants
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.
|
|---|---|---|
|
Number of Participants With Postoperative Cognitive Decline
Cognitive decline present
|
9 Participants
|
7 Participants
|
|
Number of Participants With Postoperative Cognitive Decline
Cognitive decline not present
|
8 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: Measured at 1, 3 and 6 months postoperatively.Population: The number analyzed decreases and increases at different time points due to the inconsistency of utilizing telephone calls to obtain cognitive scores, and the difficulty of reliably reaching patients.
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.
Outcome measures
| Measure |
Overall Study Enrollment
n=17 Participants
This group includes the enrollment of patients in the Lumosity arm (CT Group), as well as the patients in the usual care arm (Control Group).
|
Usual Care (Control Group)
n=19 Participants
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.
|
|---|---|---|
|
Postoperative Cognitive Dysfunction Measured Using the Montreal Cognitive Assessment (MoCA)
Postoperative t-MoCA score (0-22, 22 best) Month 1
|
20.0 score on a scale
Interval 18.0 to 21.0
|
19.0 score on a scale
Interval 18.0 to 21.0
|
|
Postoperative Cognitive Dysfunction Measured Using the Montreal Cognitive Assessment (MoCA)
Postoperative t-MoCA score (0-22, 22 best) Month 3
|
20.0 score on a scale
Interval 19.0 to 21.0
|
21.0 score on a scale
Interval 20.0 to 21.0
|
|
Postoperative Cognitive Dysfunction Measured Using the Montreal Cognitive Assessment (MoCA)
Postoperative t-MoCA score (0-22, 22 best) Month 6
|
20.0 score on a scale
Interval 19.0 to 22.0
|
20.5 score on a scale
Interval 18.0 to 21.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Postoperative visit (usually within 1 month after discharge)Population: Complete study population
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.
Outcome measures
| Measure |
Overall Study Enrollment
n=20 Participants
This group includes the enrollment of patients in the Lumosity arm (CT Group), as well as the patients in the usual care arm (Control Group).
|
Usual Care (Control Group)
n=20 Participants
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.
|
|---|---|---|
|
Postoperative Survey
The program was easy to use
|
87 Scores on a scale
Interval 75.0 to 97.0
|
—
|
|
Postoperative Survey
I enjoyed playing the games
|
85 Scores on a scale
Interval 79.0 to 91.0
|
—
|
|
Postoperative Survey
I think my memory improved
|
75 Scores on a scale
Interval 54.0 to 82.0
|
51 Scores on a scale
Interval 49.0 to 54.0
|
|
Postoperative Survey
I think my thinking ability improved
|
78 Scores on a scale
Interval 64.0 to 83.0
|
50 Scores on a scale
Interval 41.0 to 68.0
|
|
Postoperative Survey
I would be interested in CT for another surgery
|
—
|
70 Scores on a scale
Interval 50.0 to 86.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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.
Outcome measures
| Measure |
Overall Study Enrollment
n=20 Participants
This group includes the enrollment of patients in the Lumosity arm (CT Group), as well as the patients in the usual care arm (Control Group).
|
Usual Care (Control Group)
n=20 Participants
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.
|
|---|---|---|
|
Patient Satisfaction
|
90 scores on a scale
Interval 78.0 to 94.0
|
74 scores on a scale
Interval 67.0 to 87.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Postoperative visit (usually within 1 month after discharge)Population: Question not asked of the CT group participants
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.
Outcome measures
| Measure |
Overall Study Enrollment
This group includes the enrollment of patients in the Lumosity arm (CT Group), as well as the patients in the usual care arm (Control Group).
|
Usual Care (Control Group)
n=20 Participants
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.
|
|---|---|---|
|
Postoperative Survey (Cont)
|
—
|
17 Participants
|
Adverse Events
Lumosity (CT Group)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Usual Care (Control Group)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Brian O'Gara, MD, MPH
Beth Israel Deaconess Medical Center
Phone: 617-754-3189
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place