Software-guided Cognitive Stimulation to Prevents Delirium

Study Overview
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Brief Summary
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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.

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

Conditions
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Delirium in Old Age

Intervention / Treatment
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* Other: Prevention software
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>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). | Other: Placebo<br>* All patients will have a tablet without the software PREVEDEL between 09:00-19:00 hrs.<br>|
| Experimental: Experimental<br>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). | Other: Prevention software<br>* All patients will have a tablet with the software PREVEDEL between 09:00-19:00 hrs.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in delirium incidence between both groups | Delirium will be assessed with CAM (the confusion assessment method) twice a day. | 5 days | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Delirium, Prevention, Cognitive stimulation