Please select the eligibility criteria that correspond to the clinical trial below.
Title: Perioperative Cognitive Protection - Cognitive Exercise and Cognitive Reserve (The Neurobics Trial)
Brief 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. 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.


Options:
A: 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
B: Inclusion Criteria:

* Hospital admission for highly complex elective surgery

Exclusion Criteria:

* History of cognitive impairment.
* A low score in Mini-Mental State Examination (MMSE): \<23 points if the patient has 6 or more years of schooling, and \<18 points if the patient has \<6 years of schooling.
* Severe communication disorder and cultural language limitation (language other than Spanish).
* Delirium on admission or prior to the start of the intervention (measured with CAM).
* Patient enrolled in another study
C: Inclusion Criteria:

* Patients with an age equal or older than 65 years
* Hospitalized at the Acute Geriatric Unit of the "Complejo Hospitalario Universitario of Albacete"
* Valid signed informed consent by the patient or legal representative.

Exclusion Criteria:

* Agonic situation
* Non-Spanish speaking
* Severe cognitive decline (Reisberg´s Global Deterioration Scale = 7)
* Patients sharing the same room with a previously included participant
D: Patient Inclusion Criteria: medical patients who: are age ≥65, speak English or Spanish, live in the community prior to admission to the hospital, screen positive for dementia on well-validated scales (Montreal Cognitive Assessment {MoCA} ≤ 25 123-127 and AD8 \>2 128,129), and score 0.5 to 2.0 on the Clinical Dementia Rating Scale; and have a family CG as the designated study partner for the duration of the study.

Patient Exclusion Criteria: mild cognitive impairment (CDR 0.5 without functional or ADL impairments), severe dementia (CDR 3), any significant neurological condition associated with cognitive impairment other than dementia (e.g. brain tumor), a major acute psychiatric disorder, have no family caregiver to participate, are enrolled in hospice and/or have a life expectancy of six months or less, are admitted from a nursing home, or experience transfers to another unit for stays longer than 48 hours.

Family Inclusion Criteria: age 18 and above whose relatives meet inclusion criteria will be eligible if they can speak and read English or Spanish; and are related to the patient by blood, marriage, adoption, or affinity as a significant other (defined as or by the patient/legally authorized person as the primary person providing oversight and support on an ongoing basis); participate, at a minimum, in the initial assessment and development of FamPath; and able to recall at least two words on the MiniCog

Staff nurses (at the conclusion of the intervention at each site) who identify the intervention unit as the primary unit worked, and speak English or Spanish, will be included in focus groups

For the exploratory aim of assessing the cultural appropriateness of the intervention, we will recruit family caregivers who self-identify as black, Latino, Asian and white, randomly selected from the Fam-FFC sample. Approximately 10 percent of families from each ethnic group represented in the study will be approached for consent for participation in interviews. (If theoretical saturation is not reached, interviews will continue until saturation is reached). Additionally, the six nurse champions will be consented and interviewed after the study ends in his/her particular unit/setting to provide their perspective on the cultural appropriateness of Fam-FFC.

Answer: A