Software-guided Cognitive Stimulation to Prevents Delirium

NCT ID: NCT03573843

Last Updated: 2020-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-15

Study Completion Date

2019-10-30

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.

Detailed Description

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Conditions

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Delirium in Old Age

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Control

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).

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Experimental

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).

Group Type EXPERIMENTAL

Prevention software

Intervention Type OTHER

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

Interventions

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Prevention software

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

Intervention Type OTHER

Placebo

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

Intervention Type OTHER

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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Chile

OTHER

Sponsor Role lead

Responsible Party

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Eduardo Tobar

Associated professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eduardo A Tobar, MD

Role: STUDY_DIRECTOR

University of Chile

Locations

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Hospital Clínico Universidad de Chile

Santiago, International, Chile

Site Status

Countries

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Chile

Other Identifiers

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UCHID16AM0080

Identifier Type: -

Identifier Source: org_study_id

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