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Software-guided Cognitive Stimulation to Prevents Delirium

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03573843
Acronym
Prevedel
Enrollment
60
Registered
2018-06-29
Start date
2018-06-15
Completion date
2019-10-30
Last updated
2020-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delirium in Old Age

Keywords

Delirium, Prevention, Cognitive stimulation

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.

Interventions

All patients will have a tablet with the software PREVEDEL between 09:00-19:00 hrs.

OTHERPlacebo

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

Sponsors

University of Chile
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
Difference in delirium incidence between both groups5 daysDelirium will be assessed with CAM (the confusion assessment method) twice a day.

Secondary

MeasureTime frameDescription
Length of stay5 daysThe days of total hospital stay of the patients will be recorded
Severity of delirium5 daysDelirium will be evaluated with CAM-S (the confusion assessment method Severity) whenever appropriate.
Time of use of electronic device5 daysThe usage time on the mobile device (with internal device registration) will be recorded.
Functionality at discharge.5 daysFunctionality at discharge will be assessed with Barthel Index test at discharge.

Countries

Chile

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026