Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Lumos Labs, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lumosity (CT Group) | Experimental | 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. |
|
| Usual Care (Control Group) | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lumosity | Device | A neurocognitive training program designed to enhance cognitive abilities |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Brian O'Gara, MD | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30537982 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Among the 45 randomly assigned participants, 5 patients' participation was terminated and they were, therefore, excluded from subsequent analyses.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Count of Participants | Participants | Enrollment was assessed after enrollment was completed. |
|
Adverse Events were assessed through the 6 month follow up.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brian O'Gara, MD, MPH | Beth Israel Deaconess Medical Center | 617-754-3189 | bpogara@bidmc.harvard.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 25, 2017 | Feb 28, 2020 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D003693 | Delirium |
| D000079690 | Postoperative Cognitive Complications |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Defined as present or absent on any day from postoperative day 1 to postoperative day 7. |
| 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. |
| 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. |
| Postoperative visit (usually within 1 month after discharge) |
| 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) |
| 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) |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Language Status | Count of Participants | Participants |
|
| Education Level | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| 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. | Posted | Median | Inter-Quartile Range | percentage of minutes trained/prescribed | 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. | Posted | Count of Participants | Participants | 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). | The discrepancy of participants analyzed comes from missed assessments due to unavailability of study staff. | Posted | Count of Participants | Participants | 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. | 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. | Posted | Median | Inter-Quartile Range | score on a scale | Measured at 1, 3 and 6 months postoperatively. |
|
|
|
| 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. | Complete study population | Posted | Median | Inter-Quartile Range | Scores on a scale | Postoperative visit (usually within 1 month after discharge) |
|
|
|
| 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. | Posted | Median | Inter-Quartile Range | scores on a scale | Postoperative visit (usually within 1 month after discharge) |
|
|
|
| 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. | Question not asked of the CT group participants | Posted | Count of Participants | Participants | Postoperative visit (usually within 1 month after discharge) |
|
|
|
| 2 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | 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. | 0 | 20 | 0 | 20 | 0 | 20 |
Not provided
Not provided
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D060825 | Cognitive Dysfunction |
| D003072 | Cognition Disorders |
| Post-Discharge Training Adherence |
|
| Postoperative t-MoCA score (0-22, 22 best) Month 3 |
|
|
| Postoperative t-MoCA score (0-22, 22 best) Month 6 |
|
|
| I enjoyed playing the games |
|
|
| I think my memory improved |
|
|
| I think my thinking ability improved |
|
|
| I would be interested in CT for another surgery |
|
|