Software-guided Cognitive Stimulation to Prevents Delirium

Not Applicable

Completed

• Conditions: Delirium in Old Age

• Registration Number: NCT03573843
• Lead Sponsor: University of Chile

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-04
• Study Start: 2018-06-15
• Study First Submitted QC: 2018-06-19
• Study First Posted: 2018-06-29
• Primary Completion: 2018-08-31
• Study Completion: 2019-10-30
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-10
• Last Update Posted: 2020-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Difference in delirium incidence between both groups	5 days	Delirium will be assessed with CAM (the confusion assessment method) twice a day.

Secondary Outcome Measures

Name	Time	Method
Severity of delirium	5 days	Delirium will be evaluated with CAM-S (the confusion assessment method Severity) whenever appropriate.
Functionality at discharge.	5 days	Functionality at discharge will be assessed with Barthel Index test at discharge.
Time of use of electronic device	5 days	The usage time on the mobile device (with internal device registration) will be recorded.
Length of stay	5 days	The days of total hospital stay of the patients will be recorded

Trial Locations

Locations (1)

Hospital Clínico Universidad de Chile; 🇨🇱 Santiago, International, Chile