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Completed

NCT Number: NCT03573843

Software-guided Cognitive Stimulation to Prevents Delirium

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clínico Universidad de Chile

Santiago, International, 6677, Chile

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Prevention software

Other

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

Placebo

Other

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

Primary outcomes

  1. Difference in delirium incidence between both groups

    Time frame: 5 days

    Delirium will be assessed with CAM (the confusion assessment method) twice a day.

Secondary outcomes

  1. Length of stay

    Time frame: 5 days

    The days of total hospital stay of the patients will be recorded

  2. Severity of delirium

    Time frame: 5 days

    Delirium will be evaluated with CAM-S (the confusion assessment method Severity) whenever appropriate.

  3. Time of use of electronic device

    Time frame: 5 days

    The usage time on the mobile device (with internal device registration) will be recorded.

  4. Functionality at discharge.

    Time frame: 5 days

    Functionality at discharge will be assessed with Barthel Index test at discharge.

Sponsors and collaborators

Lead sponsor

University of Chile

Other

Registry information

Official study title

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

Acronym: Prevedel

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Jun 29, 2018
Registry last updated
Jan 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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