DeliriumNCT02230605
Perioperative Cognitive Protection - Cognitive Exercise and Cognitive Reserve (The Neurobics Trial)
A study testing Mini-Mental State Examination, Self-Administered Gerocognitive Examination and Geriatric Depression Scale in people with Delirium, run by Ohio State University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Delirium
- What is being tested?
- Mini-Mental State Examination, Self-Administered Gerocognitive Examination and Geriatric Depression Scale
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 322 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to 20 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 60 years of age or older
- Capable and willing to consent
- Non-cardiac/non-neurological surgery with expected hospital stay of at least 72 H
- American Society of Anesthesiologists (ASA) physical status I-IV
- English speaking
- Willingness to use a provided tablet device
- 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.
Who cannot join
- Severe visual or auditory deficits
- Illiterate
- Surgery within the previous 6 months requiring general anesthesia
- Score < 26 on initial Mini Mental Status Exam (MMSE - modified version) (24 for patients with less than high school education)
- Positive pre-surgery Confusion Assessment Method test (CAM)
- Active depression as indicated by Geriatric Depression Scale screening test (score ≥ 10)
Show all 9Show fewer
- History of Axis I or II psychiatric disorders including bipolar disorder, schizophrenia, dementia, alcohol or drug abuse
- ASA physical status V, VI
- Planned postoperative intubation
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
About this study
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:
Read more
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.
Read the detailed description
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.
- Conditions
- Delirium
- Being tested
- Mini-Mental State Examination, Self-Administered Gerocognitive Examination, Geriatric Depression Scale, Charlson Comorbidity Index, Short Form 36 Health Survey
- Keywords
- Delirium, Post Operative Delirium, PD, POD, Anesthesia, Anesthesiology, Post Operative Recovery, Post Anesthesia Care Unit, PACU, Cognition, Cognitive Impairment, Memory, Thinking, Confusion Assessment Method, CAM, Neurobics, Neuroplasticity, Lumosity, Brain Games, Cognitive Exercise
- Medical subject headings
- Delirium, Emergence Delirium, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mini-Mental State ExaminationOther
Also called MMSE
To be completed at the Screening Visit and Post-Operative Day 7 Visit (or Discharge)
Self-Administered Gerocognitive ExaminationOther
Also called SAGE
To be completed at the Screening Visit and Post-Operative Day 7 Visit (or Discharge)
Geriatric Depression ScaleOther
Also called GDS
To be completed at the Screening Visit and at POD 90
Charlson Comorbidity IndexOther
Also called CCI
To be completed at the Screening Visit and at POD 90
Short Form 36 Health SurveyOther
Also called SF-36
To be completed at the Screening Visit
Confusion Assessment MethodOther
Also called CAM
To be completed at the Day 0 (Pre-Operative) Visit, Day 0 (Post-Operative) Visit, and Day 1-7 Visits at 7:30AM ± 1.5 hrs and 6:30PM ± 1.5 hrs. (or until hospital discharge)
Memorial Delirium Assessment ScaleOther
Also called MDAS
To be completed at the Day 0 (Pre-Operative) Visit, Day 0 (Post-Operative) Visit, and Day 1-7 Visits at 7:30AM ± 1.5 hrs and 6:30PM ± 1.5 hrs. (or until hospital discharge)
Postoperative Quality of Recovery ScaleOther
Also called PQRS
To be completed at Day 0 (Post-Operative) Visit, and Day 1-7 Visits at 6:30PM ± 1.5 hrs (or until hospital discharge). Will be completed POD 7 over the phone if patient already discharged. Will be completed on POD 30 and POD 90.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Exercise | Experimental | The cognitive exercises will consist of a series of computer games focusing on five categories: memory, speed, attention, flexibility and problem-solving. Participants will be expected to complete 1 hour of Lumosity exercise daily for a minimum of 8 days prior to surgery. Participants will be instructed to complete no less than 15 minutes of exercise at a time throughout each day. Each hour of exercise, participants will work through at least 1 game under each category. Research assessments will include Mini-Mental State Examination, Self-Administered Gerocognitive Examination, Geriatric Depression Scale, Charlson Comorbidity Index, Short Form 36 Health Survey, Confusion Assessment Method, Memorial Delirium Assessment Scale and Postoperative Quality of Recovery Scale. Receives: Other: Mini-Mental State Examination; Other: Self-Administered Gerocognitive Examination; Other: Geriatric Depression Scale; Other: Charlson Comorbidity Index; Other: Short Form 36 Health Survey; Other: Confusion Assessment Method; Other: Memorial Delirium Assessment Scale; Other: Postoperative Quality of Recovery Scale |
| Normal Activity | Placebo comparator | Participants randomized into the Normal Activity group will be encouraged to maintain their normal activity level prior to surgery. These participants are asked not to alter their normal daily routine of mental exertion (i.e. watching television, reading, puzzles, etc.) and not permitted to subscribe to Lumosity while in the research study. Research assessments will include Mini-Mental State Examination, Self-Administered Gerocognitive Examination, Geriatric Depression Scale, Charlson Comorbidity Index, Short Form 36 Health Survey, Confusion Assessment Method, Memorial Delirium Assessment Scale and Postoperative Quality of Recovery Scale. Receives: Other: Mini-Mental State Examination; Other: Self-Administered Gerocognitive Examination; Other: Geriatric Depression Scale; Other: Charlson Comorbidity Index; Other: Short Form 36 Health Survey; Other: Confusion Assessment Method; Other: Memorial Delirium Assessment Scale; Other: Postoperative Quality of Recovery Scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in the incidence of Post-Operative Delirium (%)
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. The incidence of PD will be compared between the control group and the intervention group as detected by the Confusion Assessment Method (CAM) / Memorial Delirium Assessment Scale (MDAS). Once a patient is positive, they will no longer be assessed.
Measured: Post-Operative Period (Day 0 through Day 7 or Discharge, whichever comes first)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2014 (estimated)
- Study startJul 2015
- Primary completion20 May 2019
- Study completion20 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DeliriumStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 322 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michelle Humeidan, Ohio State University
- Investigators
- Michelle L Humeidan, MD,PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02230605
- Sponsor's protocol ID
- 2013H0388
- Status last verified
- Sep 2019
- First submitted
- 29 Aug 2014
- Last updated
- 11 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Humeidan ML, Reyes JC, Mavarez-Martinez A, Roeth C, Nguyen CM, Sheridan E, Zuleta-Alarcon A, Otey A, Abdel-Rasoul M, Bergese SD. Effect of Cognitive Prehabilitation on the Incidence of Postoperative Delirium Among Older Adults Undergoing Major Noncardiac Surgery: The Neurobics Randomized Clinical Trial. JAMA Surg. 2021 Feb 1;156(2):148-156. doi: 10.1001/jamasurg.2020.4371.
PubMed 33175114Humeidan ML, Otey A, Zuleta-Alarcon A, Mavarez-Martinez A, Stoicea N, Bergese S. Perioperative Cognitive Protection-Cognitive Exercise and Cognitive Reserve (The Neurobics Trial): A Single-blind Randomized Trial. Clin Ther. 2015 Dec 1;37(12):2641-50. doi: 10.1016/j.clinthera.2015.10.013. Epub 2015 Nov 17.
PubMed 26598177
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Cognitive Protection - Cognitive Exercise and Cognitive Reserve (The Neurobics Trial)
- ClinicalTrials.gov ID
- NCT02230605
- Acronym / sponsor ID
- 2013H0388
- Conditions
- Delirium
- Keywords
- Delirium, Post Operative Delirium, PD, POD, Anesthesia, Anesthesiology, Post Operative Recovery, Post Anesthesia Care Unit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 322 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- 20 May 2019 (actual)
- Study completion
- 20 Aug 2019 (actual)
- First posted
- 3 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Exercise | Experimental | Other: Mini-Mental State Examination, Other: Self-Administered Gerocognitive Examination, Other: Geriatric Depression Scale, Other: Charlson Comorbidity Index, Other: Short Form 36 Health Survey, Other: Confusion Assessment Method, Other: Memorial Delirium Assessment Scale, Other: Postoperative Quality of Recovery ScaleThe cognitive exercises will consist of a series of computer games focusing on five categories: memory, speed, attention, flexibility and problem-solving. Participants will be expected to complete 1 hour of Lumosity exercise daily for a minimum of 8 days prior to surgery. Participants will be instructed to complete no less than 15 minutes of exercise at a time throughout each day. Each hour of exercise, participants will work through at least 1 game under each category. Research assessments will include Mini-Mental State Examination, Self-Administered Gerocognitive Examination, Geriatric Depression Scale, Charlson Comorbidity Index, Short Form 36 Health Survey, Confusion Assessment Method, Memorial Delirium Assessment Scale and Postoperative Quality of Recovery Scale. |
| Normal Activity | Placebo comparator | Other: Mini-Mental State Examination, Other: Self-Administered Gerocognitive Examination, Other: Geriatric Depression Scale, Other: Charlson Comorbidity Index, Other: Short Form 36 Health Survey, Other: Confusion Assessment Method, Other: Memorial Delirium Assessment Scale, Other: Postoperative Quality of Recovery ScaleParticipants randomized into the Normal Activity group will be encouraged to maintain their normal activity level prior to surgery. These participants are asked not to alter their normal daily routine of mental exertion (i.e. watching television, reading, puzzles, etc.) and not permitted to subscribe to Lumosity while in the research study. Research assessments will include Mini-Mental State Examination, Self-Administered Gerocognitive Examination, Geriatric Depression Scale, Charlson Comorbidity Index, Short Form 36 Health Survey, Confusion Assessment Method, Memorial Delirium Assessment Scale and Postoperative Quality of Recovery Scale. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 60 years of age or older
- Capable and willing to consent
- Non-cardiac/non-neurological surgery with expected hospital stay of at least 72 H
- American Society of Anesthesiologists (ASA) physical status I-IV
- English speaking
Key exclusion criteria (9 listed)
- Severe visual or auditory deficits
- Illiterate
- Surgery within the previous 6 months requiring general anesthesia
- Score < 26 on initial Mini Mental Status Exam (MMSE - modified version) (24 for patients with less than high school education)
- Positive pre-surgery Confusion Assessment Method test (CAM)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mini-Mental State ExaminationAlso: MMSETo be completed at the Screening Visit and Post-Operative Day 7 Visit (or Discharge) | Other | Cognitive Exercise, Normal Activity |
| Self-Administered Gerocognitive ExaminationAlso: SAGETo be completed at the Screening Visit and Post-Operative Day 7 Visit (or Discharge) | Other | Cognitive Exercise, Normal Activity |
| Geriatric Depression ScaleAlso: GDSTo be completed at the Screening Visit and at POD 90 | Other | Cognitive Exercise, Normal Activity |
| Charlson Comorbidity IndexAlso: CCITo be completed at the Screening Visit and at POD 90 | Other | Cognitive Exercise, Normal Activity |
| Short Form 36 Health SurveyAlso: SF-36To be completed at the Screening Visit | Other | Cognitive Exercise, Normal Activity |
| Confusion Assessment MethodAlso: CAMTo be completed at the Day 0 (Pre-Operative) Visit, Day 0 (Post-Operative) Visit, and Day 1-7 Visits at 7:30AM ± 1.5 hrs and 6:30PM ± 1.5 hrs. (or until hospital discharge) | Other | Cognitive Exercise, Normal Activity |
| Memorial Delirium Assessment ScaleAlso: MDASTo be completed at the Day 0 (Pre-Operative) Visit, Day 0 (Post-Operative) Visit, and Day 1-7 Visits at 7:30AM ± 1.5 hrs and 6:30PM ± 1.5 hrs. (or until hospital discharge) | Other | Cognitive Exercise, Normal Activity |
| Postoperative Quality of Recovery ScaleAlso: PQRSTo be completed at Day 0 (Post-Operative) Visit, and Day 1-7 Visits at 6:30PM ± 1.5 hrs (or until hospital discharge). Will be completed POD 7 over the phone if patient already discharged. Will be completed on POD 30 and POD 90. | Other | Cognitive Exercise, Normal Activity |
Primary outcome
Reduction in the incidence of Post-Operative Delirium (%)
Time frame: Post-Operative Period (Day 0 through Day 7 or Discharge, whichever comes first)
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. The incidence of PD will be compared between the control group and the intervention group as detected by the Confusion Assessment Method (CAM) / Memorial Delirium Assessment Scale (MDAS). Once a patient is positive, they will no longer be assessed.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2019.
- Derived from this study: PubMed 33175114Humeidan ML, Reyes JC, Mavarez-Martinez A, Roeth C, Nguyen CM, Sheridan E, Zuleta-Alarcon A, Otey A, Abdel-Rasoul M, Bergese SD. Effect of Cognitive Prehabilitation on the Incidence of Postoperative Delirium Among Older Adults Undergoing Major Noncardiac Surgery: The Neurobics Randomized Clinical Trial. JAMA Surg. 2021 Feb 1;156(2):148-156. doi: 10.1001/jamasurg.2020.4371.
- Derived from this study: PubMed 26598177Humeidan ML, Otey A, Zuleta-Alarcon A, Mavarez-Martinez A, Stoicea N, Bergese S. Perioperative Cognitive Protection-Cognitive Exercise and Cognitive Reserve (The Neurobics Trial): A Single-blind Randomized Trial. Clin Ther. 2015 Dec 1;37(12):2641-50. doi: 10.1016/j.clinthera.2015.10.013. Epub 2015 Nov 17.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle L Humeidan, MD,PhD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mini-Mental State Examination, Self-Administered Gerocognitive Examination and Geriatric Depression Scale in people with Delirium, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in the incidence of Post-Operative Delirium (%) (time frame: Post-Operative Period (Day 0 through Day 7 or Discharge, whichever comes first)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02230605, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2019.