Delirium Clinical Trial
Official title:
Cognitive Training for the Prevention of Postoperative Delirium: a Pilot Study
NCT number | NCT02963961 |
Other study ID # | HUM00119087 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 6, 2017 |
Est. completion date | May 18, 2018 |
Verified date | March 2021 |
Source | University of Michigan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Postoperative delirium is a significant public health concern, affecting up to 70% of elderly patients presenting for surgery. Furthermore, postoperative delirium is associated with increased mortality, persistent cognitive decline, increased hospital length of stay, and elevated healthcare costs. Unfortunately, there is a lack of evidence-based strategies that consistently and effectively reduce the risk of delirium. In fact, although the American Geriatrics Society has released guidelines for the prevention of postoperative delirium, the evidence supporting many of the proposed preventive measures has been deemed low quality. Cognitive training exercises have been shown to improve cognitive function and functional status in community-dwelling elderly adults, and benefits may last for several months to years. Specifically, training exercises have led to improved performance in attention, short-term memory, and visuospatial processing; all of which are implicated as clinical features of delirium. Cognitive training has also strengthened connectivity in brain networks implicated in postoperative delirium. Thus, given these specific neurological benefits afforded, preoperative cognitive training may provide protection against the development of postoperative delirium. As such, the aim of this pilot study is to assess the feasibility of implementing a preoperative cognitive training program for surgical patients at high-risk for delirium and other associated complications.
Status | Completed |
Enrollment | 61 |
Est. completion date | May 18, 2018 |
Est. primary completion date | May 18, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years and older |
Eligibility | Inclusion Criteria: - Patients 60 years of age and older - Major noncardiac, non-major vascular, non-intracranial surgery - Daily access to computer and internet use prior to surgery Exclusion Criteria: - Pre-existing cognitive impairment (preoperative delirium and/or not having capacity to provide informed consent) - Severe auditory or visual impairment - Emergency surgery - No daily computer and internet access - Already participating in cognitive training exercises |
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan Medical School | Ann Arbor | Michigan |
Lead Sponsor | Collaborator |
---|---|
University of Michigan |
United States,
Kundu B, Sutterer DW, Emrich SM, Postle BR. Strengthened effective connectivity underlies transfer of working memory training to tests of short-term memory and attention. J Neurosci. 2013 May 15;33(20):8705-15. doi: 10.1523/JNEUROSCI.5565-12.2013. Erratum in: J Neurosci. 2013 Jun 19;33(25):10582. — View Citation
Rebok GW, Ball K, Guey LT, Jones RN, Kim HY, King JW, Marsiske M, Morris JN, Tennstedt SL, Unverzagt FW, Willis SL; ACTIVE Study Group. Ten-year effects of the advanced cognitive training for independent and vital elderly cognitive training trial on cognition and everyday functioning in older adults. J Am Geriatr Soc. 2014 Jan;62(1):16-24. doi: 10.1111/jgs.12607. Epub 2014 Jan 13. — View Citation
Weintraub S, Dikmen SS, Heaton RK, Tulsky DS, Zelazo PD, Bauer PJ, Carlozzi NE, Slotkin J, Blitz D, Wallner-Allen K, Fox NA, Beaumont JL, Mungas D, Nowinski CJ, Richler J, Deocampo JA, Anderson JE, Manly JJ, Borosh B, Havlik R, Conway K, Edwards E, Freund L, King JW, Moy C, Witt E, Gershon RC. Cognition assessment using the NIH Toolbox. Neurology. 2013 Mar 12;80(11 Suppl 3):S54-64. doi: 10.1212/WNL.0b013e3182872ded. — View Citation
Zelinski EM, Spina LM, Yaffe K, Ruff R, Kennison RF, Mahncke HW, Smith GE. Improvement in memory with plasticity-based adaptive cognitive training: results of the 3-month follow-up. J Am Geriatr Soc. 2011 Feb;59(2):258-65. doi: 10.1111/j.1532-5415.2010.03277.x. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Pain Severity (1) | Visual Analogue Scale (mm, 0-100, 0 = no pain, 100 = worst pain imaginable) | PACU through POD3 | |
Other | Pain Severity (2) | Behavioral Pain Scale (n, 3-12, 3 = no pain, 12 = maximum pain) | PACU through POD3 | |
Other | Postoperative Opioid Administration | Opioid consumption, converted to morphine equivalents (mg) per day | PACU through POD3 | |
Primary | Percentage of Delirious Patients per Group | Each participant who has experienced at least one episode of delirium by the postoperative day 3 time point, as determined by daily Confusion Assessment Method (CAM) screening, will then be calculated in each group to provide delirium incidence (%). | By afternoon of postoperative day (POD) 3 | |
Secondary | Cognitive Function - Attention, Focus | The Flanker Inhibitory Control and Attention Test from the NIH Toolbox Cognition Battery will be used to assess attention and focus in each study group. Uncorrected standard score (n, 0-10, 0 = no correct answers, 10 = all items answered correctly and with median reaction time 500 milliseconds or faster on each trial) will be reported within individuals to assess for cognitive function change throughout the study period. | Baseline, immediate preoperative setting, and POD 3 | |
Secondary | Cognitive Function - Memory | The List Sorting Working Memory Test from the NIH Toolbox Cognition Battery will be used to assess working memory in each study group. Uncorrected standard score (n, 0-26, 0=no items correctly recalled and sequenced, 26=all items correctly recalled and sequenced) will be reported within individuals to assess for cognitive function change throughout the study period. | Baseline, immediate preoperative setting, and POD 3 | |
Secondary | Cognitive Function - Brain Processing Speed | The Pattern Comparison Processing Speed Test from NIH Toolbox Cognition Battery will be used to assess brain processing speed in each group. Uncorrected standard score (n, 0-130, 0=no items answered correctly , 130=all items answered correctly) will be reported within individuals to assess for cognitive function change throughout the study period. Age-adjusted and fully adjusted scaled scores (n) will also be reported | Baseline, immediate preoperative setting, and POD 3 | |
Secondary | Hospital Length of Stay | Length of hospital stay (n = number of days through study completion, up to 30 days) will be assessed in each group | ||
Secondary | Length of ICU Stay | Length of ICU stay (n = number of days through study completion, up to 30 days) will be assessed in each group | ||
Secondary | Physical Therapy (PT) Sessions | Percentage (%) of prescribed PT sessions participants are able to successfully complete during the first week after surgery | Within the first 7 days after surgery |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04551508 -
Delirium Screening 3 Methods Study
|
||
Recruiting |
NCT05891873 -
Delirium in the (Neuro)Intensive/Critical Care in the Adult and Paediatric Czech Populations
|
||
Recruiting |
NCT06027788 -
CTSN Embolic Protection Trial
|
N/A | |
Recruiting |
NCT04792983 -
Cognition and the Immunology of Postoperative Outcomes
|
||
Recruiting |
NCT06194474 -
Study on Biomarkers of Postoperative Delirium in Elderly Cardiac Surgery Patients
|
||
Completed |
NCT03095417 -
Improving the Recovery and Outcome Every Day After the ICU
|
N/A | |
Completed |
NCT05395559 -
Prevalence and Recognition of Cognitive Impairment in Hospitalized Patients: a Flash Mob Study
|
||
Terminated |
NCT03337282 -
Incidence and Characteristics of Postoperative Cognitive Dysfunction in Elderly Quebec Francophone Patients
|
||
Not yet recruiting |
NCT04846023 -
Pediatric Delirium Screening in the PICU Via EEG
|
N/A | |
Not yet recruiting |
NCT04538469 -
Absent Visitors: The Wider Implications of COVID-19 on Non-COVID Cardiothoracic ICU Patients, Relatives and Staff
|
||
Not yet recruiting |
NCT03807388 -
ReMindCare App for Patients From First Episode of Psychosis Unit.
|
N/A | |
Withdrawn |
NCT02673450 -
PER3 Clock Gene Polymorphism, Clock Gene Expression and Delirium in the Intensive Care Unit.
|
||
Recruiting |
NCT03256500 -
Transcranial Direct Current Stimulation for the Treatment of Delirium
|
N/A | |
Not yet recruiting |
NCT02892968 -
ED Ultrasonographic Regional Anesthesia to Prevent Incident Delirium in Hip Fracture Patients
|
N/A | |
Completed |
NCT02890927 -
Geriatric-CO-mAnagement for Cardiology Patients in the Hospital
|
N/A | |
Recruiting |
NCT03165539 -
Cerebral Oxygen Desaturation and Post-Operative Delirium in Thoracic Surgical Patients
|
||
Completed |
NCT02554253 -
The Impact of Ketamine on Postoperative Cognitive Dysfunction, Delirium, and Renal Dysfunction
|
Phase 2 | |
Completed |
NCT02518646 -
DElirium prediCtIon in the intenSIve Care Unit: Head to Head comparisON of Two Delirium Prediction Models
|
N/A | |
Recruiting |
NCT02305589 -
The Clinical Changes Before and After Sugammadex in the Patients Undergoing Hip Surgery on the Aspect of Delirium
|
N/A | |
Completed |
NCT02628925 -
Nu-DESC DK: The Danish Version of the Nursing Delirium Screening Scale
|
N/A |