CogMe for the Prevention and Early Detection of Delirium

NCT05311761 | Unknown

• 1 other identifier: 0589-21-RMB
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed as a prospective interventional study to evaluate the CogMe system for early detection and prevention of delirium. The study will collect physiological and cognitive measurements to evaluate the ability of the CogMe system to predict and detect delirium and to aid the development of future delirium prevention methods.

Conditions

Delirium

Keywords

Elderly; Acute hospitalization; Technology

Outcome Measures

Primary Outcomes (1)

• The detection of delirium by the CogMe system

  Time between the detection of delirium by the CogMe Data Analytics model and the first diagnosis of delirium based on the Confusion Assessment Method (CAM) instrument.

  24 hours

Study Arms (1)

CogMe Personal Assistant (PA)

EXPERIMENTAL

The CogMe PA is a dedicated application built by CogMe with the purpose of assessing the cognitive functions of patients and providing them with a short and stimulating interaction. The application runs on a standard tablet. The CogMe PA is designed to be easily understandable and usable also for older adults with little or no experience in mobile applications. The questions in the Q\&A session are based on validated cognitive tests shown to be associated with delirium and are built to assess the subjective wellbeing and cognitive function of the patients. The repeated use of the application will allow to detect any changes or anomalies during the hospitalization period.

Other: CogMe Personal Assistant (PA)

Interventions

CogMe Personal Assistant (PA) OTHER

Twice a day, in the morning and evening, the electronic tablet with the CogMe PA will be given to the patient by the research assistant. Patients will be asked to respond to a short question and answer (Q\&A) session of approximately 5-10 minutes duration. This intervention will continue throughout the hospitalization period, estimated at approximately 5 days.

CogMe Personal Assistant (PA)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Male and female patients aged 65 years of age and older.
• Patients with an expected length of hospitalization of 4 days or longer.
• Patients who are conscious and cognitively able to provide written informed consent as suggested by a score of 0 on 4AT screening.
• Patients who have no diagnosis of delirium prior to enrollment.

You may not qualify if:

• Male and female patients younger than 65 years of age.
• Patients with an expected length of hospitalization of less than 4 days.
• Patients with uncorrected visual or hearing impairment.
• Patients with impaired consciousness or cognitive impairment as determined by a score of 1 or more on 4AT screening.

Sponsors & Collaborators

• Rambam Health Care Campus: lead
• CogMe Ltd: collaborator

Study Sites (1)

Rambam Health Care Campus

Haifa, North, 3109601, Israel

RECRUITING

Related Publications (6)

• Inouye SK. Delirium in older persons. N Engl J Med. 2006 Mar 16;354(11):1157-65. doi: 10.1056/NEJMra052321. No abstract available.

  PMID: 16540616 RESULT

• Hshieh TT, Yang T, Gartaganis SL, Yue J, Inouye SK. Hospital Elder Life Program: Systematic Review and Meta-analysis of Effectiveness. Am J Geriatr Psychiatry. 2018 Oct;26(10):1015-1033. doi: 10.1016/j.jagp.2018.06.007. Epub 2018 Jun 26.

  PMID: 30076080 RESULT

• Yu KH, Beam AL, Kohane IS. Artificial intelligence in healthcare. Nat Biomed Eng. 2018 Oct;2(10):719-731. doi: 10.1038/s41551-018-0305-z. Epub 2018 Oct 10.

  PMID: 31015651 RESULT

• O'Keeffe ST, Lavan JN. Predicting delirium in elderly patients: development and validation of a risk-stratification model. Age Ageing. 1996 Jul;25(4):317-21. doi: 10.1093/ageing/25.4.317.

  PMID: 8831879 RESULT

• Inouye SK, Bogardus ST Jr, Baker DI, Leo-Summers L, Cooney LM Jr. The Hospital Elder Life Program: a model of care to prevent cognitive and functional decline in older hospitalized patients. Hospital Elder Life Program. J Am Geriatr Soc. 2000 Dec;48(12):1697-706. doi: 10.1111/j.1532-5415.2000.tb03885.x.

  PMID: 11129764 RESULT

• Inouye SK, van Dyck CH, Alessi CA, Balkin S, Siegal AP, Horwitz RI. Clarifying confusion: the confusion assessment method. A new method for detection of delirium. Ann Intern Med. 1990 Dec 15;113(12):941-8. doi: 10.7326/0003-4819-113-12-941.

  PMID: 2240918 RESULT

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Tzvi Dwolatzky, MD MBBCh

  Rambam Health Care Campus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tzvi Dwolatzky, MD MBBCh

CONTACT

+972502061183; t_dwolatzky@rambam.health.gov.il

Orit Meshulam

CONTACT

+972-47772952; o_meshulam@rambam.health.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Geriatrics

Model Details: Single arm single center prospective interventional study.

Study Record Dates

• First Submitted: March 7, 2022
• First Posted: April 5, 2022
• Study Start: March 1, 2022
• Primary Completion: June 30, 2024
• Study Completion: December 31, 2024
• Last Updated: September 5, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)