Effect of Early Cognitive Stimulation Interventions on Delirium and Cognitive Functions Among Critically Ill Patients

Delirium Clinical Trial

Official title:

Effect of Early Cognitive Stimulation Interventions on Delirium and Cognitive Functions Among Critically Ill Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06115863
• Other study ID #: prevention of delirium in ICU
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2023
• Est. completion date: November 2024

Study information

• Verified date: September 2023
• Source: Damanhour University
• Contact: Shaimaa Youssif Mohamed, Demonstrator
• Phone: 01090199505
• Email: shaimaa.youssif[@]nur.dmu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Delirium is an acute change in attention and awareness that develops over a relatively short time interval and associated with additional cognitive deficits such as memory deficit, disorientation, or perceptual disturbances.

Delirium negative impact has been widely documented in the medical literature. It has been associated with increased mortality and morbidity, longer hospital stays, increase health care costs, and a longer duration of MV.

Delirium in the ICU can be prevented and treated with a combination of pharmaceutical and non-pharmaceutical interventions.

Cognitive interventions, as part of a delirium prevention strategy, are specific therapies focusing on the domains of cognitive functioning impacted by delirium such as orientation, attention, registration, recall and language.

Cognitive stimulation interventions such as orienting patients to the date, time and place, visual and auditory stimulations that focused on specific domains (orientation and registration). In addition, cognitive stimulation included cognitive training and stimulation exercises that focus on specific domains (attention, language, recall, and registration) such as analyzing exercise, recalling exercise, and cognitive-training exercises by using mobile applications .

The involvement of family members in the cognitive stimulation of critically ill patients is an underutilized resource that may benefit patients as well as gain a sense of control and purpose.

Description:

Nurses have direct contact with patients 24 hours a day, so they are in an ideal position to prevent, detect, manage, and care for patients who have delirium. The identification of predisposing or precipitating variables must be a part of the nursing intervention in order to reduce the likelihood of delirium occurring. When possible, nurses can help identify at-risk individuals and lower risk. Although a regular nursing assessment and good observational skills combined with a strong therapeutic relationship can enable nurses to recognize sudden changes in attention or consciousness, which are typical indications of delirium.

Although the effects of cognitive stimulation interventions have been extensively studied in the prevention of delirium for ICU patients, there are few studies have implemented to assess its effects when it is applied early within the first 24 hours from ICU admission worldwide, and up to our knowledge there are no national studies that have been conducted to assess early effects of such interventions on delirium in ICU. Therefore, this study will be conducted to evaluate the effect of early cognitive stimulation interventions on delirium in critically ill patients.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 130
• Est. completion date: November 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Aged =18 years.

• Newly admitted patients not more than 24 hours.

• Patient's Richmond Agitation Sedation Scale (RASS) from -1 to +1.

Exclusion Criteria:

• Patient with pre-existing brain injury and cognitive impairment.

• Patient who is delirious on admission positive for Confusion Assessment Method for the ICU (CAM ICU).

• Patient with hearing and visual impairment.

• Patients who is Hemodynamically unstable.

Related Conditions & MeSH terms

• Critical Illness
• Delirium

Intervention

Other:
• Early Cognitive Stimulation Interventions
early cognitive stimulation interventions refer to multi-dimensions of stimulative evidenced-based interventions, which are done during the first 24 hours from patient admission to the ICU. They are designed to stimulate cognitive function domains that are impacted by delirium such as attention, registration, recall, and language.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Damanhour University

References & Publications (2)

Deemer K, Myhre B, Oviatt S, Parsons M, Watson M, Zjadewicz K, Soo A, Fiest K, Posadas-Calleja J. Occupational therapist-guided cognitive interventions in critically ill patients: a feasibility randomized controlled trial. Can J Anaesth. 2023 Jan;70(1):139-150. doi: 10.1007/s12630-022-02351-9. Epub 2022 Nov 16. — View Citation

Deemer K, Zjadewicz K, Fiest K, Oviatt S, Parsons M, Myhre B, Posadas-Calleja J. Effect of early cognitive interventions on delirium in critically ill patients: a systematic review. Can J Anaesth. 2020 Aug;67(8):1016-1034. doi: 10.1007/s12630-020-01670-z. Epub 2020 Apr 24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1. To assess the effect of early cognitive stimulation interventions on incidence of delirium among 65 critically ill patients by use CAM -ICU.	Critically ill patients who undergo early cognitive stimulation interventions have a significantly lower risk of incidence delirium than those who do not. Delirium will be assessed for patients by use the Confusion Assessment Method for the ICU (CAM-ICU).	5 day from patients' admission to ICU.
Primary	2. To investigate the effect of early cognitive stimulation interventions on concentration of cognitive function among 65 critically ill patients.	Critically ill patients who undergo early cognitive stimulation interventions show improved cognitive abilities compared to those who do not. the measurement tool for cognitive function is Johns Hopkins Adapted Cognitive Exam	5 days from patients' admission to ICU.
Secondary	1. To investigate the effect of early cognitive stimulation interventions on patient's length of ICU stay.	Critically ill patients who undergo early cognitive stimulation interventions have a significantly shorter length of ICU stay than those who do not.	immediately after the intervention.