Software-guided Cognitive Stimulation to Prevents Delirium (Prevedel)

University of Chile

Status: Completed

Conditions: Delirium in Old Age

Treatments: Other: Placebo; Other: Prevention software

Study type: Interventional

Funder types: Other

Identifiers

NCT03573843

UCHID16AM0080

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

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).

Treatment:

Other: Placebo

Experimental

Experimental group

Description:

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).

Treatment:

Other: Prevention software