Delirium, Postoperative Cognitive Dysfunction
Conditions
Keywords
Cardiac Surgery, Delirium, Postoperative Cognitive Dysfunction
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.
Interventions
DEVICELumosity
A neurocognitive training program designed to enhance cognitive abilities
Sponsors
Lumos Labs, Inc.
Beth Israel Deaconess Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of Providing a Neurocognitive Training Program to Elderly Cardiac Surgical Patients - Enrollment | Enrollment was assessed after enrollment was completed. | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Postoperative Cognitive Decline | 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). |
| Number of Participants With Postoperative Delirium Measured by the Confusion Assessment Method (CAM) | 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. |
| Postoperative Cognitive Dysfunction Measured Using the Montreal Cognitive Assessment (MoCA) | 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
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction | 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. |
| Postoperative Survey (Cont) | 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. |
| Postoperative Survey | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 20 |
| 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. | 20 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Found ineligible after randomization | 0 | 2 |
| Overall Study | Withdrawal by Subject | 2 | 1 |
Baseline characteristics
| Characteristic | Usual Care (Control Group) | Total | Lumosity (CT Group) |
|---|---|---|---|
| Age, Continuous | 69 years STANDARD_DEVIATION 7 | 70 years STANDARD_DEVIATION 4.5 | 70 years STANDARD_DEVIATION 6 |
| Education Level Bachelor's degree | 5 Participants | 13 Participants | 8 Participants |
| Education Level Doctoral degree | 4 Participants | 6 Participants | 2 Participants |
| Education Level High school graduate or equivalent | 5 Participants | 6 Participants | 1 Participants |
| Education Level Master's degree | 4 Participants | 9 Participants | 5 Participants |
| Education Level Some college, associate's degree | 2 Participants | 6 Participants | 4 Participants |
| Language Status Foreign born, English is second language | 1 Participants | 4 Participants | 3 Participants |
| Language Status Native born English speaker | 19 Participants | 36 Participants | 17 Participants |
| Race/Ethnicity, Customized Race/Ethnicity American Indian or Alaskan Native | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Asian | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Multi-Racial | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Other | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Race/Ethnicity Unknown | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Race/Ethnicity White | 19 Participants | 38 Participants | 19 Participants |
| Region of Enrollment United States | 20 participants | 40 participants | 20 participants |
| Sex/Gender, Customized Female | 5 Participants | 11 Participants | 6 Participants |
| Sex/Gender, Customized Male | 15 Participants | 29 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
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.
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).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Overall Study Enrollment | Feasibility of Providing a Neurocognitive Training Program to Elderly Cardiac Surgical Patients - Adherence | Pre-Hospital Training Adherence | 39 percentage of minutes trained/prescribed |
| Overall Study Enrollment | Feasibility of Providing a Neurocognitive Training Program to Elderly Cardiac Surgical Patients - Adherence | In-Hospital Training Adherence | 6 percentage of minutes trained/prescribed |
| Overall Study Enrollment | Feasibility of Providing a Neurocognitive Training Program to Elderly Cardiac Surgical Patients - Adherence | Post-Discharge Training Adherence | 19 percentage of minutes trained/prescribed |
| Usual Care (Control Group) | Feasibility of Providing a Neurocognitive Training Program to Elderly Cardiac Surgical Patients - Adherence | Pre-Hospital Training Adherence | 0 percentage of minutes trained/prescribed |
| Usual Care (Control Group) | Feasibility of Providing a Neurocognitive Training Program to Elderly Cardiac Surgical Patients - Adherence | In-Hospital Training Adherence | 0 percentage of minutes trained/prescribed |
| Usual Care (Control Group) | Feasibility of Providing a Neurocognitive Training Program to Elderly Cardiac Surgical Patients - Adherence | Post-Discharge Training Adherence | 0 percentage of minutes trained/prescribed |
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Overall Study Enrollment | Feasibility of Providing a Neurocognitive Training Program to Elderly Cardiac Surgical Patients - Enrollment | 45 Participants |
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).
Time frame: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Overall Study Enrollment | Number of Participants With Postoperative Cognitive Decline | Cognitive decline present | 9 Participants |
| Overall Study Enrollment | Number of Participants With Postoperative Cognitive Decline | Cognitive decline not present | 8 Participants |
| Usual Care (Control Group) | Number of Participants With Postoperative Cognitive Decline | Cognitive decline present | 7 Participants |
| Usual Care (Control Group) | Number of Participants With Postoperative Cognitive Decline | Cognitive decline not present | 12 Participants |
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.
Time frame: Defined as present or absent on any day from postoperative day 1 to postoperative day 7.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Overall Study Enrollment | Number of Participants With Postoperative Delirium Measured by the Confusion Assessment Method (CAM) | Delrium present | 5 Participants |
| Overall Study Enrollment | Number of Participants With Postoperative Delirium Measured by the Confusion Assessment Method (CAM) | Delirium not present | 15 Participants |
| Usual Care (Control Group) | Number of Participants With Postoperative Delirium Measured by the Confusion Assessment Method (CAM) | Delrium present | 3 Participants |
| Usual Care (Control Group) | Number of Participants With Postoperative Delirium Measured by the Confusion Assessment Method (CAM) | Delirium not present | 17 Participants |
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Overall Study Enrollment | 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 |
| Overall Study Enrollment | 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 |
| Overall Study Enrollment | 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 |
| Usual Care (Control Group) | Postoperative Cognitive Dysfunction Measured Using the Montreal Cognitive Assessment (MoCA) | Postoperative t-MoCA score (0-22, 22 best) Month 1 | 19.0 score on a scale |
| Usual Care (Control Group) | Postoperative Cognitive Dysfunction Measured Using the Montreal Cognitive Assessment (MoCA) | Postoperative t-MoCA score (0-22, 22 best) Month 3 | 21.0 score on a scale |
| Usual Care (Control Group) | Postoperative Cognitive Dysfunction Measured Using the Montreal Cognitive Assessment (MoCA) | Postoperative t-MoCA score (0-22, 22 best) Month 6 | 20.5 score on a scale |
Other Pre-specified
Patient Satisfaction
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)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Overall Study Enrollment | Patient Satisfaction | 90 scores on a scale |
| Usual Care (Control Group) | Patient Satisfaction | 74 scores on a scale |
Other Pre-specified
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.
Time frame: Postoperative visit (usually within 1 month after discharge)
Population: Complete study population
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Overall Study Enrollment | Postoperative Survey | I think my thinking ability improved | 78 Scores on a scale |
| Overall Study Enrollment | Postoperative Survey | I enjoyed playing the games | 85 Scores on a scale |
| Overall Study Enrollment | Postoperative Survey | I think my memory improved | 75 Scores on a scale |
| Overall Study Enrollment | Postoperative Survey | The program was easy to use | 87 Scores on a scale |
| Usual Care (Control Group) | Postoperative Survey | I think my memory improved | 51 Scores on a scale |
| Usual Care (Control Group) | Postoperative Survey | I think my thinking ability improved | 50 Scores on a scale |
| Usual Care (Control Group) | Postoperative Survey | I would be interested in CT for another surgery | 70 Scores on a scale |
Other Pre-specified
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.
Time frame: Postoperative visit (usually within 1 month after discharge)
Population: Question not asked of the CT group participants
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care (Control Group) | Postoperative Survey (Cont) | 17 Participants |