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Software-guided Cognitive Stimulation to Prevents Delirium (Prevedel)

Primary Purpose

Delirium in Old Age

Status
Completed
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Prevention software
Placebo
Sponsored by
University of Chile
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Delirium in Old Age focused on measuring Delirium, Prevention, Cognitive stimulation

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Hospital Clínico Universidad de Chile

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control

Experimental

Arm 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).

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).

Outcomes

Primary Outcome Measures

Difference in delirium incidence between both groups
Delirium will be assessed with CAM (the confusion assessment method) twice a day.

Secondary Outcome Measures

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

Full Information

First Posted
May 4, 2018
Last Updated
January 10, 2020
Sponsor
University of Chile
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1. Study Identification

Unique Protocol Identification Number
NCT03573843
Brief Title
Software-guided Cognitive Stimulation to Prevents Delirium
Acronym
Prevedel
Official Title
Cognitive Stimulation Guided by a Software to Prevent Delirium in Older Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
June 15, 2018 (Actual)
Primary Completion Date
August 31, 2018 (Actual)
Study Completion Date
October 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Chile

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Delirium in Old Age
Keywords
Delirium, Prevention, Cognitive stimulation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Placebo Comparator
Arm 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).
Arm Title
Experimental
Arm Type
Experimental
Arm 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).
Intervention Type
Other
Intervention Name(s)
Prevention software
Intervention Description
All patients will have a tablet with the software PREVEDEL between 09:00-19:00 hrs.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
All patients will have a tablet without the software PREVEDEL between 09:00-19:00 hrs.
Primary Outcome Measure Information:
Title
Difference in delirium incidence between both groups
Description
Delirium will be assessed with CAM (the confusion assessment method) twice a day.
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Length of stay
Description
The days of total hospital stay of the patients will be recorded
Time Frame
5 days
Title
Severity of delirium
Description
Delirium will be evaluated with CAM-S (the confusion assessment method Severity) whenever appropriate.
Time Frame
5 days
Title
Time of use of electronic device
Description
The usage time on the mobile device (with internal device registration) will be recorded.
Time Frame
5 days
Title
Functionality at discharge.
Description
Functionality at discharge will be assessed with Barthel Index test at discharge.
Time Frame
5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eduardo A Tobar, MD
Organizational Affiliation
University of Chile
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Clínico Universidad de Chile
City
Santiago
State/Province
International
ZIP/Postal Code
6677
Country
Chile

12. IPD Sharing Statement

Plan to Share IPD
No

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Software-guided Cognitive Stimulation to Prevents Delirium

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