Cognitive Stimulation Guided by a Software to Prevent Delirium in Older Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Difference in delirium incidence between both groups
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Investigators
Eduardo Tobar
Associated professor
University of Chile