Perioperative Cognitive Protection - Cognitive Exercise and Cognitive Reserve (The Neurobics Trial)
| Status: | Recruiting |
|---|---|
| Conditions: | Neurology, Psychiatric |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 60 - Any |
| Updated: | 1/17/2019 |
| Start Date: | July 2015 |
| End Date: | December 2019 |
| Contact: | Michelle L Humeidan, MD, PhD |
| Email: | Michelle.Humeidan@osumc.edu |
| Phone: | 614.293.7308 |
Many individuals experience an acute change in thinking and reasoning skills after surgery.
This is called post-operative delirium (PD). PD symptoms typically start 1-3 days after
surgery. Advanced age has been identified as a risk factor for PD. The purpose of this study
is to determine if performing mental exercise, before surgery, will help reduce post-surgery
memory and thinking problems. Assuming a 30% incidence of PD and proposed 50% reduction of PD
in the intervention group (15% incidence), a total of 242 patients (1:1 ratio, 121 in each
group) will achieve 80% power to detect 50% reduction using chi-square test at a 5% type I
error rate. Assuming approximately 1/3 of consented patients either fail screening or do not
complete the study after consent, we expect to consent 358 patients.
At least 8 days before surgery, subjects complete a series of questionnaires to assess
baseline cognition level (or thinking ability) and status of overall well-being. At the
completion of the screening visit, qualifying subjects are randomized into two groups:
Participants randomized into the Cognitive Exercise group are expected to complete
tablet-based brain games provided by Lumosity. These subjects are given a handheld tablet for
the duration of the preoperative period. Participants in this group are expected to complete
a minimum of 10 hours within at least 8 days prior to surgery.
Participants randomized into the Normal Activity group are encouraged to carry out their
baseline daily activities, and do not have any study-related cognitive exercise expectations
before surgery. These subjects still complete the same questionnaires and assessments as the
Cognitive Exercise group throughout the study, however, are asked not to alter their normal
daily routine of mental exertion (i.e. watching television, reading, puzzles, etc.) and are
not permitted to subscribe to Lumosity while in the research study.
On the day of surgery, a baseline delirium evaluation (CAM - Confusion Assessment Method) is
taken before surgery. During surgery, research personnel monitor vital signs and medications
given. After surgery, another CAM evaluation is taken in the post-operative recovery room.
Throughout the subject's hospital stay, pain levels and medication usage are recorded. The
CAM and MDAS (Memorial Delirium Assessment Scale) are used to identify and determine severity
of PD. The evaluations are given twice daily, at at 7:30AM ± 1.5 hrs and 6:30PM ± 1.5 hrs,
for 7 days or until hospital discharge (whichever comes first). The Postoperative Quality of
Recovery Scale (PQRS) is used each post-operative day at 6:30PM ± 1.5 hrs until discharge,
and completed over the phone on POD 7 if patient discharged. The PQRS is also administered
over the phone on POD 30 and POD 90.
This is called post-operative delirium (PD). PD symptoms typically start 1-3 days after
surgery. Advanced age has been identified as a risk factor for PD. The purpose of this study
is to determine if performing mental exercise, before surgery, will help reduce post-surgery
memory and thinking problems. Assuming a 30% incidence of PD and proposed 50% reduction of PD
in the intervention group (15% incidence), a total of 242 patients (1:1 ratio, 121 in each
group) will achieve 80% power to detect 50% reduction using chi-square test at a 5% type I
error rate. Assuming approximately 1/3 of consented patients either fail screening or do not
complete the study after consent, we expect to consent 358 patients.
At least 8 days before surgery, subjects complete a series of questionnaires to assess
baseline cognition level (or thinking ability) and status of overall well-being. At the
completion of the screening visit, qualifying subjects are randomized into two groups:
Participants randomized into the Cognitive Exercise group are expected to complete
tablet-based brain games provided by Lumosity. These subjects are given a handheld tablet for
the duration of the preoperative period. Participants in this group are expected to complete
a minimum of 10 hours within at least 8 days prior to surgery.
Participants randomized into the Normal Activity group are encouraged to carry out their
baseline daily activities, and do not have any study-related cognitive exercise expectations
before surgery. These subjects still complete the same questionnaires and assessments as the
Cognitive Exercise group throughout the study, however, are asked not to alter their normal
daily routine of mental exertion (i.e. watching television, reading, puzzles, etc.) and are
not permitted to subscribe to Lumosity while in the research study.
On the day of surgery, a baseline delirium evaluation (CAM - Confusion Assessment Method) is
taken before surgery. During surgery, research personnel monitor vital signs and medications
given. After surgery, another CAM evaluation is taken in the post-operative recovery room.
Throughout the subject's hospital stay, pain levels and medication usage are recorded. The
CAM and MDAS (Memorial Delirium Assessment Scale) are used to identify and determine severity
of PD. The evaluations are given twice daily, at at 7:30AM ± 1.5 hrs and 6:30PM ± 1.5 hrs,
for 7 days or until hospital discharge (whichever comes first). The Postoperative Quality of
Recovery Scale (PQRS) is used each post-operative day at 6:30PM ± 1.5 hrs until discharge,
and completed over the phone on POD 7 if patient discharged. The PQRS is also administered
over the phone on POD 30 and POD 90.
Potential study participants will be identified one of two ways, either by the treating
physician in clinic when the decision is made to pursue surgery or by researchers monitoring
the OR schedule. When a potential participant is identified by the treating physician in
clinic, they will ask the patient if study personnel may call them to discuss the study. If
the patient agrees to be contacted, the surgeon will alert study personnel who will call the
patient to explain the study and arrange the initial study (screening) visit. Study personnel
will monitor the OR schedule and call any potential patients the surgeons have not already
identified in clinic. In this case, patients will be informed over the phone that their
surgeon has granted permission to contact them regarding the study. Surgeons will be made
aware when their patients have been approached over the phone, and updated accordingly if the
patient agrees to the screening visit and is subsequently enrolled in the study. All
screening visits will occur at the OSU Pre-operative Assessment Center (OPAC). When possible
the screening visit will co-inside with pre-operative testing per the Anesthesia Department
at OPAC.
Informed consent will occur at the initial screening visit which is to take place
approximately 2 weeks prior to surgery, but no less than 8 days pre-op. At this visit, a
member of the research team will obtain demographic information (gender, education level),
historical medical information, and information regarding medication usage. The researcher
will perform the Mini-Mental Status Exam (MMSE) - the modified version (see attached
document), Self Administered Gerocognitve Form (SAGE) - all four versions (see attached
questionnaires), Geriatric Depression Scale, Charlson Comorbidity Index, Postoperative
Quality Recovery Scale (PQRS), and Short-form 36 Health Related Quality of Life Measure.
Patients meeting inclusion criteria will be randomized to either the cognitive exercise or
control group. Patients in the cognitive exercise group will be given a tablet with
preinstalled access to Lumosity (Lumos Labs, San Francisco, CA, USA), a cognitive exercise
software application which will be used in this study. Each participant in the cognitive
exercise group will be expected to complete 1 hour of Lumosity brain exercise daily for a
minimum of 8 days prior to surgery, equaling an effective 'dose' at least 10 hours. Playing
time will be determined either by: (a) the actual in-game playing time; or (b) as calculated
by the research team during the Screening Visit (see the "Subject Diary"). The Lumosity
software allows for monitoring of participant compliance by researchers. Patients in the
control group will carry out their normal activities prior to surgery.
All patients will undergo surgery as planned. On the day of surgery, prior to proceeding to
the operating room, patients will be assessed with the Confusion Assessment Method (CAM) to
confirm no presence of delirium pre-operatively. In the Post-anesthesia Recovery Unit, a
different member of the research team (blinded to the patient's group assignment) will repeat
the CAM to assess for PD. While hospitalized, pain scores determined using the Verbal Analog
Scale and narcotic use will be obtained from the electronic medical record with at least 8
hour frequency (entered by registered nurses). All participants will be evaluated by a
blinded researcher using the combined CAM/Memorial Delirium Assessment Scale (MDAS) at 7:30AM
± 1.5 hrs and 6:30PM ± 1.5 hrs for PD on subsequent post-op days until discharge.
Additionally, the PQRS will be completed at each 6:30PM ± 1.5 hrs assessment. The PQRS, MMSE,
and SAGE will be repeated just prior to discharge or on POD 7. A different form for the SAGE
examination, as well as alternate number and word sequences for the PQRS and MMSE
assessments, will be used in order to reduce the potential influence of the learning effect.
At the end of this visit, active patient participation is complete. For subjects discharged
before POD 7, the PQRS will be given again via telephone. Follow-up visits will be conducted
on POD 30 and POD 90 via telephone. The PQRS will be obtained on POD 30, and the PQRS, GDS,
and SF-36 will be obtained on POD 90. The research team will also periodically check the
medical record during this time for readmissions and provider notes related to medical
events. Participation is complete after POD 90.
physician in clinic when the decision is made to pursue surgery or by researchers monitoring
the OR schedule. When a potential participant is identified by the treating physician in
clinic, they will ask the patient if study personnel may call them to discuss the study. If
the patient agrees to be contacted, the surgeon will alert study personnel who will call the
patient to explain the study and arrange the initial study (screening) visit. Study personnel
will monitor the OR schedule and call any potential patients the surgeons have not already
identified in clinic. In this case, patients will be informed over the phone that their
surgeon has granted permission to contact them regarding the study. Surgeons will be made
aware when their patients have been approached over the phone, and updated accordingly if the
patient agrees to the screening visit and is subsequently enrolled in the study. All
screening visits will occur at the OSU Pre-operative Assessment Center (OPAC). When possible
the screening visit will co-inside with pre-operative testing per the Anesthesia Department
at OPAC.
Informed consent will occur at the initial screening visit which is to take place
approximately 2 weeks prior to surgery, but no less than 8 days pre-op. At this visit, a
member of the research team will obtain demographic information (gender, education level),
historical medical information, and information regarding medication usage. The researcher
will perform the Mini-Mental Status Exam (MMSE) - the modified version (see attached
document), Self Administered Gerocognitve Form (SAGE) - all four versions (see attached
questionnaires), Geriatric Depression Scale, Charlson Comorbidity Index, Postoperative
Quality Recovery Scale (PQRS), and Short-form 36 Health Related Quality of Life Measure.
Patients meeting inclusion criteria will be randomized to either the cognitive exercise or
control group. Patients in the cognitive exercise group will be given a tablet with
preinstalled access to Lumosity (Lumos Labs, San Francisco, CA, USA), a cognitive exercise
software application which will be used in this study. Each participant in the cognitive
exercise group will be expected to complete 1 hour of Lumosity brain exercise daily for a
minimum of 8 days prior to surgery, equaling an effective 'dose' at least 10 hours. Playing
time will be determined either by: (a) the actual in-game playing time; or (b) as calculated
by the research team during the Screening Visit (see the "Subject Diary"). The Lumosity
software allows for monitoring of participant compliance by researchers. Patients in the
control group will carry out their normal activities prior to surgery.
All patients will undergo surgery as planned. On the day of surgery, prior to proceeding to
the operating room, patients will be assessed with the Confusion Assessment Method (CAM) to
confirm no presence of delirium pre-operatively. In the Post-anesthesia Recovery Unit, a
different member of the research team (blinded to the patient's group assignment) will repeat
the CAM to assess for PD. While hospitalized, pain scores determined using the Verbal Analog
Scale and narcotic use will be obtained from the electronic medical record with at least 8
hour frequency (entered by registered nurses). All participants will be evaluated by a
blinded researcher using the combined CAM/Memorial Delirium Assessment Scale (MDAS) at 7:30AM
± 1.5 hrs and 6:30PM ± 1.5 hrs for PD on subsequent post-op days until discharge.
Additionally, the PQRS will be completed at each 6:30PM ± 1.5 hrs assessment. The PQRS, MMSE,
and SAGE will be repeated just prior to discharge or on POD 7. A different form for the SAGE
examination, as well as alternate number and word sequences for the PQRS and MMSE
assessments, will be used in order to reduce the potential influence of the learning effect.
At the end of this visit, active patient participation is complete. For subjects discharged
before POD 7, the PQRS will be given again via telephone. Follow-up visits will be conducted
on POD 30 and POD 90 via telephone. The PQRS will be obtained on POD 30, and the PQRS, GDS,
and SF-36 will be obtained on POD 90. The research team will also periodically check the
medical record during this time for readmissions and provider notes related to medical
events. Participation is complete after POD 90.
Inclusion Criteria
1. 60 years of age or older
2. Capable and willing to consent
3. Non-cardiac/non-neurological surgery with expected hospital stay of at least 72 H
4. American Society of Anesthesiologists (ASA) physical status I-IV
5. English speaking
6. Willingness to use a provided tablet device
7. Willingness to commit at least 1 hour per day to experimental intervention (cognitive
activity/exercise) to complete a minimum of 10 hours within at least 8 days prior to
surgery.
Exclusion criteria
1. Severe visual or auditory deficits
2. Illiterate
3. Surgery within the previous 6 months requiring general anesthesia
4. Score < 26 on initial Mini Mental Status Exam (MMSE - modified version) (24 for
patients with less than high school education)
5. Positive pre-surgery Confusion Assessment Method test (CAM)
6. Active depression as indicated by Geriatric Depression Scale screening test (score ≥
10)
7. History of Axis I or II psychiatric disorders including bipolar disorder,
schizophrenia, dementia, alcohol or drug abuse
8. ASA physical status V, VI
9. Planned postoperative intubation
We found this trial at
1
site
410 W 10th Ave
Columbus, Ohio 43210
Columbus, Ohio 43210
(614) 293-8652
Phone: 614-293-7308
The Ohio State University, Wexner Medical Center Located in Columbus, The Ohio State University Wexner...
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