Software-guided Cognitive Stimulation to Prevents Delirium

Delirium in Old Age Clinical Trial

— Prevedel  

Official title:

Cognitive Stimulation Guided by a Software to Prevent Delirium in Older Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03573843
• Other study ID #: UCHID16AM0080
• Status: Completed
• Phase: N/A
• Start date: June 15, 2018
• Est. completion date: October 30, 2019

Study information

• Verified date: January 2020
• Source: University of Chile
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a pilot randomized controlled trial, comparing a group of older patients with standardized non-pharmacological delirium prevention plus a basic tablet versus a group with standardized non-pharmacological delirium prevention plus a tablet with a software of cognitive stimulation (PREVEDEL).

Software:It is a local development, including a interprofessional team of delirium healthcare experts, older patients and a team og engineers. The software was developed during the first year of this project and was inscribed for author rights.

Inclusion criteria: Older patients > 65 y.o. Admitted to medicine room or intermediate care unit > 48 hrs, and informed consent to participate.

Exclusion Criteria:Delirium positive, neuroleptic use, dementia, and non-spanish speakers.

The study was approved by ethical committee of Hospital Clinico University of Chile Standardized Non-pharmacological intervention: Health workers were previously educated in delirium, and environmental issues were implemented. This intervention coverage in nine different domains: orientation, early mobilization, environmental noise and light, sensorial deficit, sleep, hydratation, drug reduction, and family participation.

Intervention: All patients will have a tablet with or without the software PREVEDEL between 09:00-19:00 hrs.

Measures: delirium will be monitoring with CAM (Confusion Assessment Method) twice a day for 5 days.

Primary outcome: Delirium rate between both groups Secondary outcomes:Long of stay, severity od delirium, time of use of electronic device, and Barthel to discharge.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 30, 2019
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

Older patients > 65 y.o. Admitted to medicine room or intermediate care unit > 48 hrs, and informed consent to participate.

Exclusion Criteria:

Delirium positive, neuroleptic use, dementia, and non-spanish speakers.

Related Conditions & MeSH terms

• Delirium
• Delirium in Old Age

Intervention

Other:
• Prevention software
All patients will have a tablet with the software PREVEDEL between 09:00-19:00 hrs.
• Placebo
All patients will have a tablet without the software PREVEDEL between 09:00-19:00 hrs.

Locations

Country	Name	City	State
Chile	Hospital Clínico Universidad de Chile	Santiago	International

Sponsors (1)

Lead Sponsor	Collaborator
University of Chile

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in delirium incidence between both groups	Delirium will be assessed with CAM (the confusion assessment method) twice a day.	5 days
Secondary	Length of stay	The days of total hospital stay of the patients will be recorded	5 days
Secondary	Severity of delirium	Delirium will be evaluated with CAM-S (the confusion assessment method Severity) whenever appropriate.	5 days
Secondary	Time of use of electronic device	The usage time on the mobile device (with internal device registration) will be recorded.	5 days
Secondary	Functionality at discharge.	Functionality at discharge will be assessed with Barthel Index test at discharge.	5 days