DementiaNCT06042413
Prediction and Prevention of Postoperative Mortality and Morbidity
A study testing Personalized CPC Prehabilitation, Cognitive Training and Meditation in people with Dementia and Postoperative Delirium (POD), run by University of Pittsburgh at 5 sites in United States.
Trial summary
This study will contribute to creating a prospective and automated preoperative risk assessment algorithm for predicting 30-day mortality, major adverse cardiac and cerebrovascular events (MACCE), and postoperative neurocognitive outcomes following elective cardiac and vascular surgery in older adults. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dementia, Postoperative Delirium (POD), Postoperative Neurocognitive Disorder
- What is being tested?
- Personalized CPC Prehabilitation, Cognitive Training and Meditation
- Type of treatment
- Pill or oral medicine, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,200 participants
- Where
- 5 sitesUnited States
- Study dates
- Nov 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Part I Inclusion Criteria:
- 65 years of age and older
- Scheduled for major cardiac surgeries including coronary artery bypass and valvular repair and/or vascular surgeries including carotid endarterectomy, aortic aneurysm repair, and major vascular surgeries
- Informed consent
- English speaking patients
Part II Inclusion Criteria:
- Enrolled in Aim 1 / Part I Preoperative Intervention Trial
- Scheduled for high-risk, cardiac or vascular surgery requiring intraoperative neurophysiological monitoring (IONM)
Part I Exclusion Criteria:
- Children (<18 years)
- Patients unable to provide consent
- Participants undergoing same day procedures or operations (discharged same day)
- Patients with severe preoperative medical diseases such as blindness or significant visual impairment, unresolved motor weakness, or any other perioperative events or complications that would have a bearing on the patient's ability to perform study tasks, neuropsychological tests, and proposed interventions
Part II Exclusion Criteria:
- Pregnant women
- Patients do not provide consent.
- Patients are unable to participate in cognitive and other behavioral assessment due to physical limitations
- Patients refuse any blood transfusions during surgery
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites
UPMC Montefiore Hospital
Pittsburgh, Pennsylvania, 15213
Senthil Sadhasivam, MD, 4126474484, sadhasivams@upmc.edu
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, 15213
Senthilkumar Sadhasivam, 317-948-3845, ssadhasivam@IUHealth.org
Alisha Maslanka, BS, CCRC, 412-864-6779, maslankaaa@upmc.edu
UPMC Shadyside Hospital
Pittsburgh, Pennsylvania, 15213
Senthil Sadhasivam, MD, 4126474484, sadhasivams@upmc.edu
UPMC Mercy Hospital
Pittsburgh, Pennsylvania, 15219
Senthil Sadhasivam, MD, 4126474484, sadhasivams@upmc.edu
UPMC Passavant Hospital
Pittsburgh, Pennsylvania, 15237
Senthil Sadhasivam, MD, 4126474484, sadhasivams@upmc.edu
About this study
Official title: Real-world and Innovative Multimodal Prediction and Prevention of Postoperative Mortality and Multi-morbidities
This study will contribute to creating a prospective and automated preoperative risk assessment algorithm for predicting 30-day mortality, major adverse cardiac and cerebrovascular events (MACCE), and postoperative neurocognitive outcomes following elective cardiac and vascular surgery in older adults. It will evaluate associations between perioperative factors and longer-term neurocognitive outcomes, including postoperative neurocognitive disorder and dementia. In addition, this study will assess scalable, multimodal preoperative and intraoperative interventions to improve perioperative outcomes.
This study will explore two main hypotheses:
Read more
- Preoperative personalized prehabilitation with proactive cognitive and behavioral interventions will improve postoperative cognitive outcomes, morbidity, and mortality in high-risk elderly surgical patients.
- Proactive bundled intraoperative interventions are superior to reactive standard of care in reducing postoperative cognitive outcomes, MACCE, and mortality.
Expected Outcome: Improved EHR algorithm will have higher predictive accuracy for MACCE and mortality while predicting postoperative cognitive outcomes.
Read the detailed description
This study will cover the following two specific aims:
Aim 1. A pragmatic, non-randomized study to assess the effectiveness of preoperative personalized prehabilitation with proactive cognitive and behavioral interventions versus standard of care on reducing postoperative cognitive outcomes (including postoperative delirium within 30 days, postoperative cognitive decline, and dementia), MACCE, and mortality in high-risk surgical elderly patients (≥65 years). Our Electronic Health Record (EHR)-based automated machine-learning risk prediction algorithm for postoperative mortality and MACCE has been developed using >1.25 million surgical patients' data and implemented with superior performance to comparators. This EHR algorithm will identify approximately 1,000 patients at high risk for 30-day mortality and MACCE who proceed to surgery for Aim 1. Participants will receive either standard of care (n=500) or CPC-guided personalized preoperative prehabilitation with proactive cognitive or behavioral interventions (physical exercise, cognitive training, enhanced social support, and depression support) (n=500), based on real-world clinical referral practices rather than randomization. Cognitive assessments will be performed at baseline, discharge, and at 1, 3, 6, and 12 months.
Aim 2 Hypothesis: Proactive bundled intraoperative interventions are superior to standard intraoperative care in reducing postoperative cognitive outcomes, MACCE, and mortality.
Expected Outcome: The refined EHR-based risk prediction algorithm will demonstrate improved accuracy for predicting MACCE, mortality, and postoperative cognitive outcomes.
- Conditions
- Dementia, Postoperative Delirium (POD), Postoperative Neurocognitive Disorder, Major Adverse Cardiac and Cerebrovascular Events, Perioperative Complications, Postoperative Cognitive Decline
- Being tested
- Personalized CPC Prehabilitation, Cognitive Training, Meditation, Daily Exercise, Enhanced Social Support
- Keywords
- MACCE, Cognitive decline, Perioperative brain health, Neurocognitive disorder, Postoperative delirium
- Medical subject headings
- Dementia, Emergence Delirium, Postoperative Cognitive Complications, Cognitive Dysfunction, Neurocognitive Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalized CPC PrehabilitationOther
Patients referred for elective surgery will be scheduled for a preoperative evaluation (3 to 6 weeks prior to surgery) and will receive standardized and personalized assessment and prehabilitation according to UPMC disease specific algorithms
Cognitive TrainingBehavioural
Participants will be provided with access to the Lumosity (Lumos Labs) software for installation on a home device. They will be trained to navigate the touchscreen tablet and guided through an introductory series of brain exercise games focused on 5 main categories: memory, speed, attention, flexibility, and problem-solving. Patients will be asked to complete a cognitive exercise dosage of a minimum of 20 minutes a day for ≥5 days prior to their date of surgery. Research coordinators and volunteers from UPMC's Hospital Elder Life Program (HELP) will reach out to participants daily for a quick social check-in and to remind them to perform their training. Compliance data will be retrieved from the Lumosity app.
MeditationBehavioural
A single guided meditation session with instructions will be provided using a smart device. The meditation session will last for at least 10 minutes daily starting at least 1-week prior to surgery. If the subject does not own a smart device, one will be provided or meditation will be completed in-person or over the phone.
Daily ExerciseBehavioural
Participants in the intervention group will meet with an occupational or physical therapist approximately 1-6 weeks before surgery who will discuss the potential benefits of exercise and give directions for an easy strength training exercise. Participants will then be provided with a video link for a guided exercise and encouraged to walk or perform a seated strength exercise for ≥ 5 minutes each day for at least 1 week before surgery and after surgery. Patient reported frequency, fitness app compliance and exercise duration with REDCap email or mobile link or over telephone will be collected before and after surgery. Patients will be cleared by an occupational or physical therapist to perform the upper-extremity exercises and will confirm the exercises are not contraindicated after surgery. An occupational or physical therapist will see subject again post-surgery to mitigate risk of injury.
Enhanced Social SupportBehavioural
Research coordinators and volunteers from the Hospital Elder Life Program (HELP) will contact participants prior to surgery to discuss concerns, provide regular social support, and remind participants to complete assigned cognitive exercises. The role of family members and caregivers in supporting the participant will also be discussed, and their involvement will be encouraged when appropriate.
Participants in the CPC preoperative intervention group may receive preoperative interventions to address depressive symptoms as part of CPC-guided prehabilitation, when clinically indicated.
Proactive Bundle InterventionsOther
Participants randomized to the proactive bundled intervention group (Group D) will receive routine intraoperative SSEP and EEG monitoring and proactive optimization of intraoperative physiology, including maintaining mean arterial pressure ≥65 mmHg, adequate oxygenation, opioid sparing analgesia, and avoidance of deep anesthesia and benzodiazepines.
If persistent focal changes in SSEP and EEG (i.e., changes in one hemisphere) occur, reactive measures will be implemented to increase cerebral perfusion, including ensuring hematocrit >30, maintaining anesthetic BIS >50-60, and initiating stroke management and thrombectomy if clinically indicated
Pre-operative Standard of CareProcedure or surgery
Participants will receive routine preoperative clinical care per institutional standard practice.
Intra-operative Standard of CareProcedure or surgery
This includes routine intraoperative SSEP and EEG monitoring. Physician oversight and interpretation of real-time neuromonitoring data will be performed using a combined on-site and remote model at UPMC. In the event that changes in EEG or SSEP are considered significant by the oversight neurophysiologists, the surgical team will be immediately informed so that immediate appropriate action can be taken to reverse the change.
| Study group | Role | What they receive |
|---|---|---|
| CPC Preoperative Intervention (Aim 1) | Experimental | Participants referred to the Center for Perioperative Care (CPC) by their surgical team will receive preoperative prehabilitation and proactive cognitive and behavioral interventions prior to surgery. Assignment to this group is not randomized and reflects real world clinical practice. Participants will receive standard intraoperative monitoring during surgery. Receives: Other: Personalized CPC Prehabilitation; Behavioral: Cognitive Training; Behavioral: Meditation; Behavioral: Daily Exercise; Behavioral: Enhanced Social Support; Procedure: Intra-operative Standard of Care |
| Preoperative Standard of Care (Aim 1) | Active comparator | Participants who do not receive CPC referral will receive standard preoperative care prior to surgery. Assignment to this group is not randomized. Participants will receive standard intraoperative monitoring during surgery. Receives: Procedure: Pre-operative Standard of Care; Procedure: Intra-operative Standard of Care |
| Proactive Bundled Intraoperative Interventions (Aim 2) | Experimental | Participants in Aim 2 are drawn from Aim 1 participants who meet IONM eligibility. Participants requiring intraoperative neurophysiological monitoring will be randomized on the day of surgery to receive proactive bundled intraoperative interventions in addition to standard intraoperative monitoring. Receives: Other: Proactive Bundle Interventions; Procedure: Intra-operative Standard of Care |
| Reactive Intraoperative Standard of Care (Aim 2) | Active comparator | Participants in Aim 2 are drawn from Aim 1 participants who meet IONM eligibility. Participants requiring intraoperative neurophysiological monitoring will be randomized on the day of surgery to receive reactive standard of care intraoperative management with routine SSEP and EEG monitoring. Receives: Procedure: Intra-operative Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Delirium (POD)
Postoperative delirium will be assessed using the Confusion Assessment Method (CAM). Participants will be classified as having delirium or not having delirium based on standard CAM criteria. A positive CAM indicates the presence of delirium.
Measured: At baseline screening, then up to 30 days post-operatively
Secondary outcomes (8)
Depression
Patient Health Questionnaire (PHQ-8) will be used to assess depression symptoms. Scores range from 0 to 27, with higher scores indicating more severe depression. Scoring is as follows: 1 to 4 minimal, 5 to 9 mild, 10 to 14 moderate, 15 to 19 moderately severe, and 20 to 27 severe depression.
Measured: at discharge and then at post-operative months of 1, 3, 6, and 12.
Dementia
Dementia severity will be assessed using the Clinical Dementia Rating scale (CDR). Scores range from 0 (none) to 3 (severe).
Measured: Post-operative months 6 and 12.
Postoperative Cognitive Decline (POCD)
Cognitive function will be assessed using the Montreal Cognitive Assessment (MoCA). Scores range from 0 to 30, with higher scores indicating better cognitive function. Postoperative cognitive decline will be defined as a decline in MoCA score compared with the preoperative baseline.
Measured: Post-operative months 1, 3, 6, and 12.
Postoperative Neurocognitive Disorder (PND)
Postoperative neurocognitive disorder will be assessed based on changes from preoperative baseline in standardized cognitive assessments, including the Montreal Cognitive Assessment (MoCA). Declines in cognitive performance relative to baseline will be used to identify postoperative neurocognitive disorder.
Measured: Post-operative months 1 and 3.
30-day Major Adverse Cardiac and Cerebrovascular Events (MACCE)
This outcome measures whether a participant experiences any major adverse cardiac or cerebrovascular event within 30 days after surgery. Events included in this composite outcome are death from any cause, myocardial infarction (heart attack), stroke, or cardiac arrest. Participants will be counted once if they experience one or more of these events during the 30 day postoperative period.
Measured: Within 30 days post-surgery.
Acute Kidney Injury (AKI)
Incidence of postoperative acute kidney injury (AKI) within 48 hours.
AKI is defined as below:
Increase in serum creatinine by ≥0.3 mg/dL (≥26.5 micromol/L) within 48 hours, or Increase in serum creatinine to ≥1.5 times preoperative baseline value.
Urine volume <0.5 mL/kg/hour for at least six hours
Measured: within 48 hours
Major Adverse Limb Events (MALE)
Incidence of major adverse limb events including surgical or catheter-based revascularization or amputation. MALE includes any open surgical revascularization procedure (i.e., femoral endarterectomy, bypass surgery, thrombectomy or embolectomy, etc), catheter directed lysis to the lower extremities, and above ankle amputation.
Measured: Post-operative months 1, 3, 6, and 12.
Postoperative Stroke
Incidence of postoperative stroke confirmed by clinical diagnosis.
Measured: Within 30 days post-surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2023
- Study startNov 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe 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
- Model description
- Up to 1,200 participants aged 65 years and older scheduled for elective cardiac or vascular surgery will be screened. Approximately 1,000 higher-risk participants who proceed to surgery will be included in Aim 1. Aim 1 is a pragmatic, non-randomized comparison in which approximately 500 participants receive CPC-guided preoperative prehabilitation and cognitive or behavioral interventions (Group A), and approximately 500 participants receive preoperative standard of care without CPC referral (Group B). Assignment is based on real-world clinical referral practices. Participants from Aim 1 who require intraoperative neurophysiological monitoring will be screened for Aim 2. Eligible participants (approximately 500) will be stratified by Aim 1 group and randomized 1:1 to reactive standard-of-care intraoperative management (Group C, n=250) or proactive bundled intraoperative interventions (Group D, n=250).
- Masking
- None (open label)
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Senthil Sadhasivam, University of Pittsburgh
- Investigators
- Senthilkumar Sadhasivam, MD, MPH, MBA, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06042413
- Sponsor's protocol ID
- STUDY25110125
- Status last verified
- Jun 2026
- First submitted
- 6 Sep 2023
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-world and Innovative Multimodal Prediction and Prevention of Postoperative Mortality and Multi-morbidities
- ClinicalTrials.gov ID
- NCT06042413
- Acronym / sponsor ID
- STUDY25110125
- Conditions
- Dementia, Postoperative Delirium (POD), Postoperative Neurocognitive Disorder, Major Adverse Cardiac and Cerebrovascular Events, Perioperative Complications, Postoperative Cognitive Decline
- Keywords
- MACCE, Cognitive decline, Perioperative brain health, Neurocognitive disorder, Postoperative delirium
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 18 Sep 2023 (actual)
- 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.
This study will contribute to creating a prospective and automated preoperative risk assessment algorithm for predicting 30-day mortality, major adverse cardiac and cerebrovascular events (MACCE), and postoperative neurocognitive outcomes following elective cardiac and vascular surgery in older adults. It will evaluate associations between perioperative factors and longer-term neurocognitive outcomes, including postoperative neurocognitive disorder and dementia. In addition, this study will assess scalable, multimodal preoperative and intraoperative interventions to improve perioperative outcomes.
This study will explore two main hypotheses:
- Preoperative personalized prehabilitation with proactive cognitive and behavioral interventions will improve postoperative cognitive outcomes, morbidity, and mortality in high-risk elderly surgical patients.
- Proactive bundled intraoperative interventions are superior to reactive standard of care in reducing postoperative cognitive outcomes, MACCE, and mortality.
Expected Outcome: Improved EHR algorithm will have higher predictive accuracy for MACCE and mortality while predicting postoperative cognitive outcomes.
Detailed description
This study will cover the following two specific aims:
Aim 1. A pragmatic, non-randomized study to assess the effectiveness of preoperative personalized prehabilitation with proactive cognitive and behavioral interventions versus standard of care on reducing postoperative cognitive outcomes (including postoperative delirium within 30 days, postoperative cognitive decline, and dementia), MACCE, and mortality in high-risk surgical elderly patients (≥65 years). Our Electronic Health Record (EHR)-based automated machine-learning risk prediction algorithm for postoperative mortality and MACCE has been developed using >1.25 million surgical patients' data and implemented with superior performance to comparators. This EHR algorithm will identify approximately 1,000 patients at high risk for 30-day mortality and MACCE who proceed to surgery for Aim 1. Participants will receive either standard of care (n=500) or CPC-guided personalized preoperative prehabilitation with proactive cognitive or behavioral interventions (physical exercise, cognitive training, enhanced social support, and depression support) (n=500), based on real-world clinical referral practices rather than randomization. Cognitive assessments will be performed at baseline, discharge, and at 1, 3, 6, and 12 months.
Aim 2 Hypothesis: Proactive bundled intraoperative interventions are superior to standard intraoperative care in reducing postoperative cognitive outcomes, MACCE, and mortality.
Expected Outcome: The refined EHR-based risk prediction algorithm will demonstrate improved accuracy for predicting MACCE, mortality, and postoperative cognitive outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Up to 1,200 participants aged 65 years and older scheduled for elective cardiac or vascular surgery will be screened. Approximately 1,000 higher-risk participants who proceed to surgery will be included in Aim 1. Aim 1 is a pragmatic, non-randomized comparison in which approximately 500 participants receive CPC-guided preoperative prehabilitation and cognitive or behavioral interventions (Group A), and approximately 500 participants receive preoperative standard of care without CPC referral (Group B). Assignment is based on real-world clinical referral practices. Participants from Aim 1 who require intraoperative neurophysiological monitoring will be screened for Aim 2. Eligible participants (approximately 500) will be stratified by Aim 1 group and randomized 1:1 to reactive standard-of-care intraoperative management (Group C, n=250) or proactive bundled intraoperative interventions (Group D, n=250).
| Arm | Type | Receives |
|---|---|---|
| CPC Preoperative Intervention (Aim 1) | Experimental | Other: Personalized CPC Prehabilitation, Behavioral: Cognitive Training, Behavioral: Meditation, Behavioral: Daily Exercise, Behavioral: Enhanced Social Support, Procedure: Intra-operative Standard of CareParticipants referred to the Center for Perioperative Care (CPC) by their surgical team will receive preoperative prehabilitation and proactive cognitive and behavioral interventions prior to surgery. Assignment to this group is not randomized and reflects real world clinical practice. Participants will receive standard intraoperative monitoring during surgery. |
| Preoperative Standard of Care (Aim 1) | Active comparator | Procedure: Pre-operative Standard of Care, Procedure: Intra-operative Standard of CareParticipants who do not receive CPC referral will receive standard preoperative care prior to surgery. Assignment to this group is not randomized. Participants will receive standard intraoperative monitoring during surgery. |
| Proactive Bundled Intraoperative Interventions (Aim 2) | Experimental | Other: Proactive Bundle Interventions, Procedure: Intra-operative Standard of CareParticipants in Aim 2 are drawn from Aim 1 participants who meet IONM eligibility. Participants requiring intraoperative neurophysiological monitoring will be randomized on the day of surgery to receive proactive bundled intraoperative interventions in addition to standard intraoperative monitoring. |
| Reactive Intraoperative Standard of Care (Aim 2) | Active comparator | Procedure: Intra-operative Standard of CareParticipants in Aim 2 are drawn from Aim 1 participants who meet IONM eligibility. Participants requiring intraoperative neurophysiological monitoring will be randomized on the day of surgery to receive reactive standard of care intraoperative management with routine SSEP and EEG monitoring. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
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 |
|---|---|---|
| Personalized CPC PrehabilitationPatients referred for elective surgery will be scheduled for a preoperative evaluation (3 to 6 weeks prior to surgery) and will receive standardized and personalized assessment and prehabilitation according to UPMC disease specific algorithms | Other | CPC Preoperative Intervention (Aim 1) |
| Cognitive TrainingParticipants will be provided with access to the Lumosity (Lumos Labs) software for installation on a home device. They will be trained to navigate the touchscreen tablet and guided through an introductory series of brain exercise games focused on 5 main categories: memory, speed, attention, flexibility, and problem-solving. Patients will be asked to complete a cognitive exercise dosage of a minimum of 20 minutes a day for ≥5 days prior to their date of surgery. Research coordinators and volunteers from UPMC's Hospital Elder Life Program (HELP) will reach out to participants daily for a quick social check-in and to remind them to perform their training. Compliance data will be retrieved from the Lumosity app. | Behavioural | CPC Preoperative Intervention (Aim 1) |
| MeditationA single guided meditation session with instructions will be provided using a smart device. The meditation session will last for at least 10 minutes daily starting at least 1-week prior to surgery. If the subject does not own a smart device, one will be provided or meditation will be completed in-person or over the phone. | Behavioural | CPC Preoperative Intervention (Aim 1) |
| Daily ExerciseParticipants in the intervention group will meet with an occupational or physical therapist approximately 1-6 weeks before surgery who will discuss the potential benefits of exercise and give directions for an easy strength training exercise. Participants will then be provided with a video link for a guided exercise and encouraged to walk or perform a seated strength exercise for ≥ 5 minutes each day for at least 1 week before surgery and after surgery. Patient reported frequency, fitness app compliance and exercise duration with REDCap email or mobile link or over telephone will be collected before and after surgery. Patients will be cleared by an occupational or physical therapist to perform the upper-extremity exercises and will confirm the exercises are not contraindicated after surgery. An occupational or physical therapist will see subject again post-surgery to mitigate risk of injury. | Behavioural | CPC Preoperative Intervention (Aim 1) |
| Enhanced Social SupportResearch coordinators and volunteers from the Hospital Elder Life Program (HELP) will contact participants prior to surgery to discuss concerns, provide regular social support, and remind participants to complete assigned cognitive exercises. The role of family members and caregivers in supporting the participant will also be discussed, and their involvement will be encouraged when appropriate. Participants in the CPC preoperative intervention group may receive preoperative interventions to address depressive symptoms as part of CPC-guided prehabilitation, when clinically indicated. | Behavioural | CPC Preoperative Intervention (Aim 1) |
| Proactive Bundle InterventionsParticipants randomized to the proactive bundled intervention group (Group D) will receive routine intraoperative SSEP and EEG monitoring and proactive optimization of intraoperative physiology, including maintaining mean arterial pressure ≥65 mmHg, adequate oxygenation, opioid sparing analgesia, and avoidance of deep anesthesia and benzodiazepines. If persistent focal changes in SSEP and EEG (i.e., changes in one hemisphere) occur, reactive measures will be implemented to increase cerebral perfusion, including ensuring hematocrit >30, maintaining anesthetic BIS >50-60, and initiating stroke management and thrombectomy if clinically indicated | Other | Proactive Bundled Intraoperative Interventions (Aim 2) |
| Pre-operative Standard of CareParticipants will receive routine preoperative clinical care per institutional standard practice. | Procedure or surgery | Preoperative Standard of Care (Aim 1) |
| Intra-operative Standard of CareThis includes routine intraoperative SSEP and EEG monitoring. Physician oversight and interpretation of real-time neuromonitoring data will be performed using a combined on-site and remote model at UPMC. In the event that changes in EEG or SSEP are considered significant by the oversight neurophysiologists, the surgical team will be immediately informed so that immediate appropriate action can be taken to reverse the change. | Procedure or surgery | CPC Preoperative Intervention (Aim 1), Preoperative Standard of Care (Aim 1), Proactive Bundled Intraoperative Interventions (Aim 2), Reactive Intraoperative Standard of Care (Aim 2) |
Primary outcome
Postoperative Delirium (POD)
Time frame: At baseline screening, then up to 30 days post-operatively
Postoperative delirium will be assessed using the Confusion Assessment Method (CAM). Participants will be classified as having delirium or not having delirium based on standard CAM criteria. A positive CAM indicates the presence of delirium.
8 secondary outcomes
Depression
Time frame: at discharge and then at post-operative months of 1, 3, 6, and 12.
Dementia
Time frame: Post-operative months 6 and 12.
Postoperative Cognitive Decline (POCD)
Time frame: Post-operative months 1, 3, 6, and 12.
Postoperative Neurocognitive Disorder (PND)
Time frame: Post-operative months 1 and 3.
30-day Major Adverse Cardiac and Cerebrovascular Events (MACCE)
Time frame: Within 30 days post-surgery.
Acute Kidney Injury (AKI)
Time frame: within 48 hours
Major Adverse Limb Events (MALE)
Time frame: Post-operative months 1, 3, 6, and 12.
Postoperative Stroke
Time frame: Within 30 days post-surgery.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Individual participant dataSharing planned: No
Related trials for Dementia
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
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.
Senthilkumar Sadhasivam, MD, MPH, MBA principal investigator
University of Pittsburgh
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Personalized CPC Prehabilitation, Cognitive Training and Meditation in people with Dementia and Postoperative Delirium (POD), run by University of Pittsburgh at 5 sites 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?
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: opening soon, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alisha Maslanka, BS, CCRC (4128646779, maslankaaa@upmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Delirium (POD) (time frame: At baseline screening, then up to 30 days post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Nov 2026.