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Clinical Trials/NCT03573843
NCT03573843
Completed
Not Applicable

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

University of Chile1 site in 1 country60 target enrollmentJune 15, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Delirium in Old Age
Sponsor
University of Chile
Enrollment
60
Locations
1
Primary Endpoint
Difference in delirium incidence between both groups
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 15, 2018
End Date
October 30, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Chile
Responsible Party
Principal Investigator
Principal Investigator

Eduardo Tobar

Associated professor

University of Chile

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Difference in delirium incidence between both groups

Time Frame: 5 days

Delirium will be assessed with CAM (the confusion assessment method) twice a day.

Secondary Outcomes

  • Severity of delirium(5 days)
  • Functionality at discharge.(5 days)
  • Time of use of electronic device(5 days)
  • Length of stay(5 days)

Study Sites (1)

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