Software-guided Cognitive Stimulation to Prevents Delirium
- Conditions
- Delirium in Old Age
- Interventions
- Other: Prevention softwareOther: Placebo
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
Older patients > 65 y.o. Admitted to medicine room or intermediate care unit > 48 hrs, and informed consent to participate.
Delirium positive, neuroleptic use, dementia, and non-spanish speakers.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Experimental Prevention software Patients who meet the inclusion / exclusion criteria will be randomly assigned to the experimental group:They will continue to receive standard prevention measures: Detection of delirium, education of health care team and the patient's family, sleep hygiene plan, early mobilization, resolve sensory impairments, and delivery of information of temporal-spatial reorientation in continuously, plus the use of software installed on a mobile device designed to support the prevention of delirium (Prevention software). Control Placebo Patients who meet the inclusion / exclusion criteria will be randomly assigned to the Control group: They will continue to receive the standard prevention measures: delirium detection, treatment health team education and the patient's family, sleep hygiene plan, early mobilization , resolve sensorial deterioration, and delivery of information of temporal-spatial reorientation in a continuous manner, plus the use of a mobile device without installed delirium prevention software (placebo).
- 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